back pain
Chronic non-specific low back pain (CNSLBP) is a major cause of disability worldwide. Conventional pharmacological treatments offer limited benefits and carry potential risks, prompting interest in alternative approaches, including homeopathy. The objective of this study was to evaluate the short-term efficacy and safety of a standardised homeopathic biotherapic (Lumbar Vertebra, LM2 potency) for CNSLBP.
A randomised, double-blind, crossover, placebo-controlled clinical trial was conducted with 120 participants diagnosed with CNSLBP. Participants received both the biotherapic and placebo in two treatment phases separated by a washout period. The primary outcome was pain intensity (numeric rating scale); secondary outcomes included functional disability (Oswestry Disability Index), adverse events and use of pain medications. Data were analysed using random effects generalised linear models.
Both the biotherapic and placebo interventions led to significant within-group reductions in pain and disability (p = 0.001 and p < 0.001 respectively). However, no statistically significant differences were observed between the two interventions for either outcome (pain: p = 0.435; disability: p = 0.840). The magnitude of change in pain intensity did not reach the pre-defined minimal clinically important difference (MCID), and mean pain scores at the study endpoint remained above the inclusion threshold. Adverse events were mild and comparable across groups.
The authors concluded that no specific effect of the Lumbar Vertebra LM2 biotherapic was demonstrated. Improvements are likely due to non-specific effects such as the therapeutic environment, patient expectations and placebo response. Clinicians should consider the substantial role of non-specific responses in CNSLBP and avoid medications with unfavourable risk–benefit profiles.
One the one hand, the authors from the Department of Medicine, Federal University of São Carlos, São Carlos, Sao Paulo, the School Health Unit, Federal University of São Carlos, São Carlos, Sao Paulo, and the epartment of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil should be congratulated for publishing a squarely negative result in the journal ‘Homeopathy’ that is known for publishing even the most implausible positive findings.
On the other hand, one might criticise them: why on earth did they ever conceive the hypothesis that homeopathy in general or “Lumbar Vertebra LM2 biotherapic” in particular might be effective for CNSLBP (the study did not receive any funding or financial support, apart from the study medications donated by HN-Cristiano Pharmacy (Santana, São Paulo, Brazil), which had no role in the study design, data collection, analysis, interpretation or discussion of the results)? I have never met a homeopaths who would make such a claim, and one could easily argue that such a trial is an unethical waste of resources.
The ‘Smallwood Report‘, entitled “The Role of Complementary and Alternative Medicine in the NHS” was published in October 2005. It recommended greater integration of so-called alternative medicine (SCAM) into the UK’s National Health Service and to address “effectiveness gaps” in treating chronic and psychosocial conditions, claiming potential cost savings.
Its core recommendations were:
- NICE assessment: Urged Health Ministers to task the National Institute for Health and Clinical Excellence (NICE) with a full review of the cost-effectiveness of therapies like acupuncture, chiropractic, osteopathy, herbal medicine, and homeopathy.
- Targeted applications: Suggested these SCAM options for lower back pain (manipulative therapies over conventional), asthma (homeopathy), common colds (echinacea), and other chronic issues where orthodox medicine falls short, potentially reducing absenteeism and NHS costs by hundreds of millions.
- Implementation steps: Promote GP referrals to SCAM, target deprived communities, prioritize research on cost-effectiveness/safety, address regulatory barriers, and use case studies showing reduced GP visits and secondary care savings.
At the time, I called its evidence “grossly misleading,” citing ignored Cochrane reviews showing no superiority for most of the claims. Many critics agreed with me, and the Lancet editor Richard Horton famoulsy called it “dangerous nonsense”.
As the recommendations were pure BS, it is comforting to note that – 20 years later – they have been largely ignored.
NICE assessments:
NICE has issued selective endorsements—e.g., acupuncture and manipulative therapies for low back pain—but stopped short of broad SCAM evaluations, often citing “insufficient evidence” or requiring further trials, directly countering the report’s call for comprehensive cost-effectiveness reviews. No large-scale NICE program emerged to validate the report’s claimed savings (hundreds of millions annually), and guidelines frequently dismiss or deprioritize unproven modalities like homeopathy.
NHS integration status:
- Limited GP referrals: Sporadic pilots exist (e.g., acupuncture in some pain clinics, osteopathy/chiropractic for musculoskeletal issues), often GP-led and adjunctive, but not systematic; social prescribing now favors mindfulness over traditional SCAM.
- Funding barriers: Most Integrated Care Boards (ICBs) classify SCAM as “low priority” absent robust evidence, funding only exceptional cases in palliative or pain management pathways; many services closed due to austerity post-2010.
- No deprived-community focus: The report’s equity push for high-need areas saw negligible uptake, with barriers like clinician resistance and regulatory hurdles persisting.
The report’s optimistic case studies (e.g., Glastonbury) proved anecdotal and unscaled, undermined by critiques highlighting flawed evidence (e.g., ignored Cochrane reviews). Today, NHS policy emphasizes evidence-based conventional care, with SCAM relegated to private or niche settings – realization sits at ~10-20% for endorsed therapies, 0% for broader vision.
In other words, ignoring the report has saved the NHS many millions. More importantly, it has prevented UK evidence-based healthcare from getting watered down by ineffective therapies.
Could that also have happened without my loud protests (e.g. here and here) at the time?
Nobody can know for sure?
But when I feel a little bit down, I tell myself that I had an important role in saving the UK millions!
The aim of this study was to determine the effectiveness of spinal manipulation and clinician-supported biopsychosocial self-management vs medical care for adults with increased risk of chronic disabling LBP.
This 2 × 2 factorial randomized clinical trial enrolled participants in 3 research clinics at the Universities of Minnesota and Pittsburgh from November 2018 to May 2023; final follow-up was in June 2024. Adults with acute or subacute LBP at moderate to high risk of chronicity based on the STarT Back tool were randomized to 1 of 4 groups, with interventions lasting up to 8 weeks. Statistical analysis was conducted from November 2024 to June 2025.
These interventions were:
- Spinal manipulation therapy (n = 201),
- supported self-management (n = 305),
- combined supported self-management with spinal manipulation (n = 193),
- guideline-based medical care (n = 301).
Physical therapists and chiropractors provided spinal manipulation and supported self-management.
The 2 primary outcomes averaged over a follow-up of 1 year were monthly low back disability (Roland-Morris Disability Questionnaire) and weekly pain intensity (numerical rating scale). Secondary analysis examined the proportion of participants achieving a 50% or higher reduction in the primary outcome measures.
Among the 1000 participants randomized (mean [SD] age, 47 [16] years; 58% female), 93% completed the trial. The omnibus test for differences across the 4 treatment groups was statistically significant for disability (P = .001; supported self-management, 4.7; spinal manipulation, 5.5; combined supported self-management with spinal manipulation, 4.8; medical care, 5.9) but not pain intensity (P = .16; supported self-management, 2.8; spinal manipulation, 3.0; combined supported self-management with spinal manipulation, 2.8; medical care, 3.0). Averaged over 12 months, LBP disability was significantly lower compared with medical care for supported self-management (mean difference, −1.2 [95% CI, −1.9 to −0.5]) and supported self-management with spinal manipulation (mean difference, −1.1 [95% CI, −1.9 to −0.3]) but not spinal manipulation alone (mean difference, −0.4 [95% CI, −1.2 to 0.4]). Group differences in pain intensity were not statistically significant; point estimates ranged from −0.2 to 0. Both supported self-management groups had higher proportions of patients achieving a 50% or greater reduction in disability (supported self-management, 67%; spinal manipulation, 54%; combined supported self-management with spinal manipulation, 65%; medical care, 54%).
The authors concluded that for patients with acute or subacute LBP at increased risk of chronic disabling LBP, clinician-supported biopsychosocial self-management showed statistically significant but small reductions in disability, but not pain, vs medical care over 1-year follow-up, and spinal manipulation alone showed no significant difference for either outcome.
These findings are very bad news for chiropractors (the profession that uses spinal manipulations more than any other): spinal manipulation does not generate effects that are in the least convincing. This is particularly remarkable, since the study was not blinded. It means that, even the undoubtedly powerful placebo effect associated with spinal manipulation did not render the outcome more favourable.
I said it many times, and I will say it again: For LBP, many therapies generate similarly marginally positive effects but no treatment is truly convincing. In this situation, we should choose one that is at least inexpensive and free of severe adverse effects. And that evidently cannot be spinal manipulation!
Non-specific low back pain is a common condition with substantial socioeconomic implications. Pulsed electromagnetic field (PEMF) therapy is said to generate benefits in pain reduction and improvement of physical function in patients with pain-associated disorders like osteoarthritis. However, studies had heterogeneous settings. The aim of this systematic review was to assess the effects of PEMF on pain and function on patients with non-specific low back pain.
A systematic literature search of randomized controlled trials in PubMed, MEDLINE, EMBASE, Cochrane Library, and PEDro was performed (from inception until 15/5/2023). Outcome measures assessed pain and function.
Nine randomized controlled trials with 420 participants (n = 420) were included. The studies compared PEMF vs. placebo-PEMF, PEMF and conventional physical therapy vs. conventional physical therapy alone, PEMF and conventional physical therapy vs. placebo-PEMF and conventional physical therapy, PEMF vs. high-intensity laser therapy (HILT) vs. conventional physical therapy, and osteopathic manipulative treatment (OMT) and PEMF vs. PEMF alone vs. placebo-PEMF vs. OMT alone. Five of the nine included studies showed statistically significant pain reduction and improvement in physical function in comparison to their control groups (p < 0.05). There was substantial heterogeneity among the groups of the study, with a wide range of duration (10-30 min), treatments per week (2-7/week), applied frequencies (3-50 Hz), and intensities (2mT-150mT). No serious adverse event had been reported in any study. The included studies showed solid methodological quality, with an overall score of 7.2 points according to the PEDro scale.
The authors concluded that the results of the present systematic review suggest that the use of PEMF for patients with non-specific low back pain is beneficial in terms of pain reduction and enhancement of physical function, particularly if used as an addition to conventional physical therapy modalities. It has also been shown that PEMF is a safe therapy for the treatment of non-specific low back pain. Further high-quality studies with larger sample sizes and standardized protocols are necessary. The studies should also focus on determining the optimal parameters of frequency and intensity to advance PEMF application for all pain disorders.
PEMF therapy is a non-invasive treatment widely used by physiotherapist and some practitioners of so-called alternative medicine (SCAM). It applies low-frequency electromagnetic waves to the body. PEMF therapy acts like a wireless charger for your body, sending pulses of energy that penetrate deep into your tissues to jumpstart cellular recovery. Because your body contains conductive fluids (like blood) and charged ions (like calcium and potassium), the PEMF device is said to induce very small electrical currents within your tissues. In turn, the induced current is claimed to stimulate the mitochondria. This, according to proponents, boosts the production of ATP. The pulses are also said to influence the movement of ions across cell membranes, particularly calcium which triggers a cascade of beneficial biochemical reactions, such as the release of nitric oxide, which dilates blood vessels to improve circulation. Lastly, PEMF are claimed to help “calm” the chemical signals that cause chronic inflammation, switching the cellular environment from a state of stress to a state of healing.
While these assumptions look like wild extrapolations, the more crucial question is whether PEMF is clinically effective. The present review seems to tell us that it works for back pain. Yet, I am not convinced.
Most of the RCTs are not of good quality. Many did not blind patients or therapists. Only 2 made a direct comparison against a placebo, and those did not blind patients or check the success of blinding them. As the authors noted, there is plenty of heterogeneity in the included RCTs. All this adds up to a high level of uncertainty about the effectiveness of PEMF.
In summary, I fear that the authors of this review are too optimistic and lack critical thinking in evaluating the existing evidence. My conclusion therefore differs from theirs:
Many RCTs suggest that PEMF is effective for non-specific low back pain. Yet, due to serious limitations of the primary studies, no firm conclusion can be drawn.
The authors found very low‐certainty evidence (downgraded for study limitations, inconsistency, and imprecision) that SMT may result in a medium reduction in pain compared to no treatment at one month (MD ‐13.99, 95% CI ‐27.33 to ‐0.66; I2 = 89%; 4 studies, 325 participants), but the evidence is very uncertain. They found low‐certainty evidence (downgraded for study limitations and imprecision) that SMT may result in a large improvement in functional status compared to no treatment at one month (SMD ‐0.84, 95% CI ‐1.32 to ‐0.35; I2 = 71%; 4 studies, 312 participants).
SMT versus other conservative interventions
Low‐certainty evidence (downgraded for inconsistency) indicated that SMT may result in little to no difference in pain (MD ‐4.72, 95% CI ‐8.26 to ‐1.17; I2 = 89%; 31 studies, 4109 participants) and may result in a small improvement in functional status (SMD ‐0.25, 95% CI ‐0.38 to ‐0.11; I2 = 73%; 28 studies, 3940 participants) compared to other conservative interventions at one month.
These effects, however, should be interpreted with caution due to the substantial statistical heterogeneity for which there is no clear explanation.
Less than half of the studies (47%) reported on adverse events, of which 12 studies reported these systematically. Adverse events in the SMT group were limited to muscle soreness, stiffness, and/or transient increase in pain. None of the studies registered any serious complications related to either the experimental or control group treatment. The evidence is very uncertain about the adverse effects of SMT.
Authors’ conclusions: When SMT is compared to sham SMT/placebo, it may result in a small improvement in pain and medium improvement in functional status in adults with chronic low back pain. When compared to no treatment, SMT may result in a medium improvement in pain and a large improvement in functional status. When compared to other conservative interventions, SMT may result in little to no difference in pain and a small improvement in functional status. The evidence is of low to very low certainty, largely due to the fact that the effects of SMT were examined in trials conducted in different settings and populations, with different types of SMT technique, dosage, and frequency of treatment. Continuing to conduct RCTs in the same manner will neither strengthen the evidence nor our confidence in it.
Once again, it has been confirmed that most trials of SMT are, because of their failure to report adverse effects, in violation of ethical standards. But the importance of this excellent review lies elsewhere. Despite 76 published RCTs, there is huge uncertainty about the benefits of SAM. What should we make of this fact?
In my view, it highlights that:
- the studies are often of poor quality;
- the effect of SMT are so small that they are negligibel;
- patients with back pain should look for treatments that are safe and effective;
- the choice can therefore not be SMT.
Low back pain (LBP) is a significant public health issue due to its high prevalence and associated disability burden. Clinical practice guidelines recommend non-pharmacological/non-surgical interventions for managing pain and function in people with LBP. This overview of Cochrane review is aimed ato providing accessible, high-quality evidence on the effects of non-pharmacological and non-surgical interventions for people with LBP and to highlight areas of remaining uncertainty and gaps in the evidence regarding the effects of these interventions for people with LBP.
the team searched the Cochrane Database of Systematic Reviews from inception to 15 April 2023, to identify Cochrane reviews of randomised controlled trials testing the effect of non-pharmacological/non-surgical interventions, unrestricted by language. Major outcomes were pain intensity, function and safety. Two authors independently assessed eligibility, extracted data and assessed the quality of the reviews using AMSTAR 2 (A MeaSurement Tool to Assess Systematic Reviews) and the certainty of the evidence using GRADE. The primary comparison was placebo/sham.
A total of 31 Cochrane reviews were included of 644 trials that randomised 97,183 adults with LBP. The team had high confidence in the findings of 19 reviews, moderate confidence in the findings of two reviews, and low confidence in the findings of 10 reviews. They present results for non-pharmacological/non-surgical interventions compared to placebo/sham or no treatment/usual care at short-term (≤ three months) follow-up. Placebo/sham comparisons Acute/subacute LBP Compared to placebo, there is probably no difference in function (at one-week follow-up) for spinal manipulation (standardised mean difference (SMD) -0.08, 95% confidence interval (CI) -0.37 to 0.21; 2 trials, 205 participants; moderate-certainty evidence). Data for safety were reported only for heated back wrap. Compared to placebo, heated back wrap may result in skin pinkness (6/128 participants versus 1/130; 2 trials; low-certainty evidence). Chronic LBP Compared to sham acupuncture, acupuncture probably provides a small improvement in function (SMD -0.38, 95% CI -0.69 to -0.07; 3 trials, 957 participants; moderate-certainty evidence). Compared to sham traction, there is probably no difference in pain intensity for traction (0 to 100 scale, mean difference (MD) -4, 95% CI -17.7 to 9.7; 1 trial, 60 participants; moderate-certainty evidence). Data for safety were reported only for acupuncture. There may be no difference between acupuncture and sham acupuncture for safety outcomes (risk ratio (RR) 0.68, 95% CI 0.42 to 1.10; I2 = 0%; 4 trials, 465 participants; low-certainty evidence). No treatment/usual care comparisons Acute/subacute LBP Compared to advice to rest, advice to stay active probably provides a small reduction in pain intensity (SMD -0.22, 95% CI -0.02 to -0.41; 2 trials, 401 participants; moderate-certainty evidence). Compared to advice to rest, advice to stay active probably provides a small improvement in function (SMD -0.29, 95% CI -0.09 to -0.49; 2 trials, 400 participants; moderate-certainty evidence). Data for safety were reported only for massage. There may be no difference between massage and usual care for safety (risk difference 0, 95% CI -0.07 to 0.07; 1 trial, 51 participants; low-certainty evidence). Chronic LBP Compared to no treatment, acupuncture probably provides a medium reduction in pain intensity (0 to 100 scale, mean difference (MD) -10.1, 95% CI -16.8 to -3.4; 3 trials, 144 participants; moderate-certainty evidence), and a small improvement in function (SMD -0.39, 95% CI -0.72 to -0.06; 3 trials, 144 participants; moderate-certainty evidence). Compared to usual care, acupuncture probably provides a small improvement in function (MD 9.4, 95% CI 6.15 to 12.65; 1 trial, 734 participants; moderate-certainty evidence). Compared to no treatment/usual care, exercise therapies probably provide a small to medium reduction in pain intensity (0 to 100 scale, MD -15.2, 95% CI -18.3 to -12.2; 35 trials, 2746 participants; moderate-certainty evidence), and probably provide a small improvement in function (0 to 100 scale, MD -6.8, 95% CI -8.3 to -5.3; 38 trials, 2942 participants; moderate-certainty evidence). Compared to usual care, multidisciplinary therapies probably provide a medium reduction in pain intensity (SMD -0.55, 95% CI -0.83 to -0.28; 9 trials, 879 participants; moderate-certainty evidence), and probably provide a small improvement in function (SMD -0.41, 95% CI -0.62 to -0.19; 9 trials, 939 participants; moderate-certainty evidence). Compared to no treatment, psychological therapies using operant approaches probably provide a small reduction in pain intensity (SMD -0.43, 95% CI -0.75 to -0.11; 3 trials, 153 participants; moderate-certainty evidence). Compared to usual care, psychological therapies (including progressive muscle relaxation and behavioural approaches) probably provide a small reduction in pain intensity (0 to 100 scale, MD -5.18, 95% CI -9.79 to -0.57; 2 trials, 330 participants; moderate-certainty evidence), but there is probably no difference in function (SMD -0.2, 95% CI -0.41 to 0.02; 2 trials, 330 participants; moderate-certainty evidence). It is uncertain whether there is a difference between non-pharmacological/non-surgical interventions and no treatment/usual care for safety (very low-certainty evidence).
The authors concluded that spinal manipulation probably makes no difference to function compared to placebo for people with acute/subacute LBP. Acupuncture probably improves function slightly for people with chronic LBP, compared to sham acupuncture. There is probably no difference between traction and sham traction for pain intensity in people with chronic LBP. Compared to advice to rest, advice to stay active probably reduces pain intensity slightly and improves function slightly for people with acute LBP. Acupuncture probably reduces pain intensity, and improves function slightly for people with chronic LBP, compared to no treatment. Acupuncture probably improves function slightly for people with chronic LBP, compared to usual care. Exercise therapies probably reduce pain intensity, and improve function slightly for people with chronic LBP, compared to no treatment/usual care. Multidisciplinary therapies probably reduce pain intensity, and improve function slightly for people with chronic LBP, compared to usual care. Compared to usual care, psychological therapies probably reduce pain intensity slightly, but probably make no difference to function for people with chronic LBP.
The findings of this overview might surprise some chiropractors, however, it did not surprise me at all*. I have stated more often than I care to remember that, for LBP, we currently have no approach that is truly convincing. One form of so-called alternative medicine (SCAM) seems to be roughly as effective (or ineffective) as the next. Where they might differ is safety and cost. On both of these measures chiropractic spinal manipulation is less convincing than some of the other options available, as we have discussed ad nauseam on this blog.
So, in a nutshell, the message to LBP patients can be put simply: stay away from chiros, keep active and, if you insist, use whatever other form of SCAM that you fancy, that is safe and inexpensive.
PS
*I was, however, surprised that the authors had low confidence in the findings of 10 of the 31 reviews. Cochrane reviews should be the most reliable evidence available to date!!!
Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments offer limited efficacy and carry substantial risks, warranting the development of safe and effective alternatives. This multicenter, randomized, placebo-controlled phase 3 trial evaluated the efficacy and safety of the herbal extract VER-01 in CLBP.
It enrolled 820 adults with CLBP (VER-01, n = 394; placebo, n = 426) and included a double-blind 12-week treatment phase (phase A), a 6-month open-label extension (phase B), followed by either a 6-month continuation (phase C) or randomized withdrawal (phase D). The primary endpoint of phase A was a change in mean numeric rating scale (NRS) pain intensity, with a change in total neuropathic pain symptom inventory (NPSI) score as a key secondary endpoint in participants with a neuropathic pain component (PainDETECT > 18). The primary endpoint for phase D was time to treatment failure.
The study met its primary endpoint in phase A, with a mean pain reduction of -1.9 NRS points in the VER-01 group (mean difference (MD) versus placebo = -0.6, 95% confidence interval (CI) = -0.9 to -0.3; P < 0.001). Pain further decreased to -2.9 NRS points in phase B, with effects sustained through phase C. The study also met its key secondary endpoint of phase A, with a mean NPSI decrease of -14.4 (standard error, 3.3) points from baseline in the VER-01 arm (MD versus placebo = -7.3, 95% CI = -13.2 to -1.3; P = 0.017). Although phase D did not meet its primary endpoint (hazard ratio = 0.75, 95% CI = 0.44-1.27; P = 0.288), pain increased significantly more with placebo upon withdrawal (MD = 0.5, 95% CI = 0.0-1.0; P = 0.034). In phase A, the incidence of adverse events-mostly mild to moderate and transient-was higher with VER-01 than with placebo (83.3% versus 67.3%; P < 0.001). VER-01 was well-tolerated, with no signs of dependence or withdrawal.
The authors of this well-designed trial concluded that this phase 3 study provides robust evidence supporting the efficacy and safety of VER-01 in the treatment of CLBP. These findings highlight the importance of further research with VER-01 in other chronic pain conditions and suggest that VER-01 could play an important role in modern pain management.
VER-01 was developed by the German biopharmaceutical company Vertanical. It is a standardized full-spectrum extract from a specific Cannabis sativa strain (DKJ127 L). This means it contains a defined mix of the plant’s compounds, including cannabinoids (such as low levels of THC—tetrahydrocannabinol—and trace amounts of CBD and cannabigerol), terpenes, and other bioactive compounds like beta-caryophyllene and alpha-bisabolol. It is designed to harness the synergistic “entourage effect” of these compounds.
The extract has also recently been shown to be superior to opioids. An RCT concluded that VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.
PS
Given the option of either having spinal manipulation (or any other form of unproven so-called alternative medicine) or a safe and standardised cannabis extract, I certainly know what I would choose!
PPS
Vertanical has submitted marketing applications for approval in several European countries (where it is expected to be sold under the brand name Exilby if approved). The company is also preparing for a late-stage trial in the US to support a subsequent filing with the FDA. If approved, VER-01 would be the first full-spectrum cannabis extract authorized specifically for chronic low back pain and potentially a new class of medicine for chronic pain management.
Gua Sha is a form of so-called alternative medicine (SCAM) that I have reoprted about before, e.g.:
- Gua sha: who cares how it works, when it is unproven that it works?
- Gua sha, a reasonable therapy?
- Gua Sha: torture or treatment?
Chronic nonspecific low back pain (CNSLBP) is associated with thoracolumbar fascia (TLF) dysfunction. However, the structural effects of Gua Sha, a Traditional Chinese Medicine technique, remain unclear.
This study aimed to explore the acute and short-term effects of Gua Sha therapy on TLF thickness, pain intensity, and related physiological parameters in patients with CNSLBP.
Thirty-two participants with CNSLBP were randomized to receive Gua Sha or hot pack therapy, a commonly used conservative treatment for low back pain, once a week for 4 weeks. The effects of the two treatments were compared. TLF thickness, pain, and related parameters were measured at baseline and immediately after the first and fourth interventions. A 2 (group) × 3 (time) repeated measures ANOVA was used for data analysis.
With increasing intervention, both groups showed significant improvements in pain intensity and dysfunction (P < .001), significant reductions in tissue hardness and pressure pain threshold (P < .05), and significant increases in skin temperature and lumbar flexibility (P < .001). However, only the Gua Sha group significantly reduced TLF thickness immediately after the first intervention (MD = 0.388, 95% CI: 0.101-0.675; P = .01) and immediately after the fourth session (MD = 0.607, 95% CI: 0.199-1.015, P = .005). The heart rate variability-related indicators did not reach statistical significance (P > .05), but their trends were favorable.
The authors concluded that Gua Sha can effectively relieve pain, improve function, and regulate tissue mechanical properties in CNSLBP patients and its effects may be achieved through multiple pathways. Although the single and 4-session interventions were not significantly better than heat in improving fascial thickness, it performs better in pain and flexibility clinical outcomes, supporting its potential value as a complementary therapy. Future studies with larger samples and longer periods are needed to clarify its mechanism of action and optimize treatment options.
Gua sha, sometimes referred to as “scraping”, “spooning” or “coining”, is a traditional Chinese treatment that has
spread to several other Asian countries. It has long been popular in Vietnam and is now also becoming well-known in the West. The treatment consists of scraping the skin with a smooth edge placed against the pre-oiled skin surface, pressed down firmly, and then moved downwards along muscles or meridians. According to its proponents, gua sha stimulates the flow of the vital energy ‘chi’ and releases unhealthy bodily matter from blood stasis within sore, tired, stiff or injured muscle areas.
It is easy to imagine that Gua Sha is associated with sizable placebo effects. This means one needs to think carefully about how to control for tham in clinical trials, if we want to know whether the treatment works beyond placebo. I am not sure how to achieve this, but I am quite certain that the current study failed to do it. Thus its results merely showed that Gua Sha is just as useless as another therapy thay is unproven for CNSLBP.
And what about the thoracolumbar fascia thickness? I think that its significance is entirely speculative. Moreover, the reliability of its measurement seems questionable. Most likely, it is yet another red herring in a paper already more than full of fishy stuff.
PS
I stated it many times before, but I must say it again: almost any odd SCAM (e.g. chiropractic!) works a little for back pain – particularly if you test it in lousy studies and don’t control for placebo effects.
The United States spends more money on the care of back and neck pain than any other health condition. Despite this, the cost-effectiveness for many recommended treatments is unclear. Our primary objective for this project was to estimate the cost-effectiveness of spinal manipulative therapy (SMT), supervised exercise therapy (ET), and home exercise and advice (HEA) for spinal pain in the U.S.
The researchers analyzed cost and clinical outcome data from eight randomized trials conducted in the U.S. using an individual participant data meta-analysis approach. They calculated cost-effectiveness from the societal and healthcare perspective of various comparisons between SMT, ET, and HEA. Incremental cost-effectiveness ratios (ICERs) were calculated using quality-adjusted life years as the main outcome.
The 8 trials included a total of 1803 participants and 1488 (83%) provided complete data. Incremental cost-effectiveness ratios and probabilities of cost-effectiveness varied substantially between studies; thus, the reseaarchers did not conduct meta-analysis and report findings from individual trials.
Cost-effectiveness findings were favorable for SMT compared to HEA for acute neck pain (ICERs below $50k/QALY) and when added to HEA for chronic back-related leg pain and chronic neck pain in older adults (better outcomes and lower costs). However, SMT was not likely cost-effective compared to HEA for chronic back pain in adults or when added to HEA for older adults (higher costs and worse outcomes).
Findings for SMT were favorable when compared to ET in adults with chronic back pain and when added to ET for chronic neck pain in adults (better outcomes and lower costs) and chronic back pain in adolescents (ICERs below $50k/QALY). However, SMT is not likely cost-effective when compared to ET for chronic neck pain in adults (ICERs below $70k/QALY for exercise) and findings were inconsistent across outcomes in older adults with chronic back pain.
Finally, ET may be cost-effective compared to HEA for adults with chronic neck pain (ICERs largely between $100-$200k/QALY), but not for chronic back pain or when added to HEA for older adults with chronic neck or back pain (higher costs and worse outcomes).
The authors concluded that overall based on willingness to pay thresholds of $50-$200k/QALY, there was moderate to high probability that spinal manipulation is cost-effective relative to HEA for neck pain and back-related leg pain, but not for chronic back pain. There was also moderate to high probability spinal manipulation was cost-effective relative to exercise therapy for chronic back pain but findings were mixed for neck pain and more favorable in older adults. Cost-effectiveness findings for exercise therapy were mostly not favorable relative to less intensive home exercise programs as costs were higher, and outcomes were often worse.
The authors admit that their analyses have several limitations: Randomized clinical trials are often designed to detect important differences in disease-specific clinical outcomes that are most likely to be impacted by the treatments assessed (e.g., pain severity, disability). Important measures for assessing cost-effectiveness include general health outcomes like changes in QALYs, healthcare use, and missed work. These measures were collected alongside disease-specific measures, but the trials were not powered to detect important differences in cost-effectiveness outcomes. Participants self-reported their use of healthcare and medications along with number of missed workdays. We did not have access to administrative data for healthcare use or costs. While access to administrative data would have reduced potential measurement error for these variables, it is not without limitations due to the high variability in coverage and re-imbursement policies for healthcare procedures across insurance products in the U.S. Costs for reduced productivity due to spinal pain included missed work in and outside of the home, but costs due to reduced productivity while still at work (i.e., presenteeism) were not included. This is an important limitation as costs due to reduced productivity while at work consistently account for a large proportion of total costs in spinal pain burden of illness studies. Finally, all studies were conducted in the U.S. with resources valued using U.S. prices and findings are not likely generalizable to populations or healthcare systems in other countries.
The authors stress that additional studies are needed to assess the cost-effectiveness of these approaches relative to medical care, the most common treatment approach in the US , as well as other guideline recommended treatments such as massage, acupuncture, mindfulness-based stress reduction, tai chi, yoga, and cognitive behavioral therapy
In view of these limitations and the fact that just 8 trials could be included, the relatively firm comclusions are surprising, in my view. To me, much of the data look unconvincing, somewhat random, inconsistent and implausible. could it be that the authors were trying to generate and emphacize positive results? After all, most of them are affiliated to the “Integrative Health and Wellbeing Research Program Earl E. Bakken Center for Spirituality & Healing, University of Minnesota”!
This systematic review was aimed at evaluating if musculoskeletal manipulations (MMs), including osteopathic manipulation and chiropractic care, are effective to improve quality of life, pain intensity and function in older adults with musculoskeletal disorders.
Randomised controlled trials, controlled non-randomised trials and open label trials evaluating the efficacy and safety of MM such as osteopathic manipulation, chiropractic manipulation, myofascial release, craniosacral therapy, as monotherapy or adjunctive therapies in older people (age ≥65 years) with musculoskeletal disorders. The main outcomes included pain intensity, functionality and quality of life. Additionally, other related outcomes were considered, such as medical use duration, mood, mobility, motion, strength and endurance. Finally, we considered any adverse events.
Selection and data extraction were performed independently by two authors. The effect estimates for each study were performed using Review Manager V.5.14. Continuous outcomes were analysed using the mean difference (95% CI). The methodological quality of the included studies was assessed using the Cochrane Risk of Bias tool 2 (RoB 2). No meta-analysis was performed.
Five parallel randomised controlled trials were included, with a total sample size of 676 participants (41.6% women with a mean age of 77.3 years): 34 with chronic pain, 265 with neck pain and 377 with low back pain. MMs were not effective in patients with chronic pain, neither in pain intensity nor in functionality.
For neck pain, considering the main outcomes, only in one of the two studies was there a statistically significant improvement in neck pain intensity only at week 12 for spinal manipulative treatment (SMT)+home exercise (HE) compared with HE alone (ES=-0.90 (95% CI -1.46 to -0.34); p=0.002).
For low back pain, SMT+HE showed a statistically significant reduction in pain at 12 weeks compared with HE (ES=-0.79 (95% CI -1.39 to -0.19) p=0.010.
For neck pain and low back pain, no statistically significant improvement in functional status and quality of life was observed with MM compared with any control group.
RoB 2 showed a high risk of bias in three studies and some concerns in the others. At the domain level, the lowest risk was observed in the randomisation process (80% with some concerns). All five studies reported adverse events, none of which were serious.
The authors concluded that this systematic review highlights the need for further investigation into complementary therapies, particularly osteopathy, for chronic pain management and prevention in elderly individuals. The results of the current work emphasise that there is a need to further investigate this topic and move the focus more on the promotion of healthy and management behaviours (eg, more physical activity, self-efficacy and adaptive coping, less healthcare utilisation, medication use) and less on the pain symptoms. The fundamental need for complementary medicine, and in particular MM such as chiropractic care and osteopathic manipulative treatment, is the development of clinical trials and RCTs to assess efficacy on quality of life, pain, functionality and general health of the elderly patient. These will help us to determine where MM can be significant.
This, it seems to me, is merely a polite way of stating that neither chiropractic nor osteopathy are supported by sound evidence, and that therapeutic claims by chiropractors and osteopaths are usually hugely exaggerated. Therefore, the prudent thing to do, if you are suffering from back or neck pain, is to use treatments that are less expensive and less likely to cause severe, sometimes life-threatening adverse effects.
