The objective of this RCT was to compare the effects of
- spinal thrust-manipulation + electrical dry needling + various medications (TMEDN-group)
- to non-thrust peripheral joint/soft-tissue mobilization + exercise + interferential current + various medications(NTMEX-group)
on pain and disability in patients with subacromial pain syndrome (SAPS).
Patients with SAPS were randomized into the TMEDN group (n=73) or the NTMEX group (n=72). Primary outcomes included the shoulder pain and disability index (SPADI) and the numeric pain rating scale (NPRS). Secondary outcomes included Global Rating of Change (GROC) and medication intake. The treatment period was 6 weeks; with follow-up at 2 weeks, 4 weeks, and 3 months.
At 3 months, the TMEDN group experienced significantly greater reductions in shoulder pain and disability compared to the NTMEX group. Effect sizes were large in favour of the TMEDN group. At 3 months, a greater proportion of patients within the TMEDN group achieved a successful outcome (GROC≥+5) and stopped taking medication.
The authors concluded that cervicothoracic and upper rib thrust-manipulation combined with electrical dry needling resulted in greater reductions in pain, disability and medication intake than non-thrust peripheral joint/soft-tissue mobilization, exercise and interferential current in patients with SAPS. These effects were maintained at 3 months.
The authors of this trial have impressive looking affiliations:
- American Academy of Manipulative Therapy Fellowship in Orthopaedic Manual Physical Therapy, Montgomery, AL.
- Montgomery Osteopractic Physiotherapy & Acupuncture Clinic, Montgomery, AL.
- Research Physical Therapy Specialists, Columbia, SC.
- Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.
- Cátedra de Clínica, Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain.
- Copper Queen Community Hospital, Bisbee, AZ.
- BenchMark Physical Therapy, Atlanta, GA.
- Eastside Medical Care Center, El Paso, TX.
- Department of Physical Therapy, Georgia State University, Atlanta, GA.
- Tybee Wellness & Osteopractic, Tybee Island, Georgia, GA.
If one expected a well-designed study from all this collective expertise, one would have been disappointed.
Any such clinical trial should be answering a simple question: is therapy XX effective? It is about pinning an observed effect on to a treatment. It is about establishing cause and effect. It is about finding an answer to a clinically relevant question.
The above study does none of that. Even if we accepted its result as valid, it could be interpreted as meaning one of many different things, for instance:
- Acupuncture was effective.
- Dry needling was effective.
- The electrical current was effective.
- Mobilisation made things worse.
- Exercise made things worse.
- one or multiple positive or negative interactions between the therapies.
- The drugs in the experimental group were more effective than those taken by controls.
- The experimental group adhered to their drug prescriptions better than controls.
- Any mixture of the above.
So, the reader of this paper can chose which of the interpretations he or she prefers. I suggest that:
- Any researcher who designs a foreseeably nonsensical trial should go back to school.
- Any ethics committee that passes such a study needs to retire.
- Any funder who gives money for it wastes scarce resources.
- Any reviewer who recommends publication needs to learn about trial design.
- Any editor who publishes such a trial needs to go.
The point I am trying to make is that conducting a clinical trial comes with responsibilities. Poorly designed studies are not just a waste of resources, they are a disservice to patients, they undermine the public’s trust in science and they are unethical.