Results of a feasibility randomized controlled trial of osteopathy on neck-shoulder pain in computer users

Participants

• Numbers: 30 people (8 female and 11 male)
• Criteria of inclusion: adults (age 18-65 years), who use a computer as a part of their job for an average time of 5 hours a day for at least a year, having experienced pain between neck and shoulders for a time inferior to 3 months, without a specific diagnosis or a clear onset for that pain, without any neurological, rheumatological or other medical conditions that may mimic that pain between neck and shoulders, no use of analgesics at the time of recruitment, no neurologic symptoms (eg, paresthesia or hypoesthesia), absence of pacemakers and no allergy to adhesives, no previous experience of OMT and no clear understanding of what OMT is
• Groups of study: 3 groups obtained by randomization
  • Group 1: OMT, 10 people (6 female and 4 male, mean age 41.6 years)
  • Group 2: sham treatment, 10 people (6 female and 4 male, mean age 37.9 years)
  • Group 3: no treatment, 10 people (6 female and 4 male, mean age 39.5 years)

Interventions and evaluations

• Various inclusion criteria were evaluated through telephone interview (eg, pain information)
• Data collection through demographic and occupational questionnaire
• Evaluation at the visit of the body composition (weight, muscle mass, fat mass and BMI) through bioimpedenziometry and neurological evaluation to rule out neurological deficits
• At the first visit, after the treatment and after 2-4 days, evaluation of pain intensity in both superior trapezius muscles through NRS, of pain threshold of the superior trapezius muscles and of the C7 vertebra through PPT, followed by the evaluation of work efficiency through the execution of a writing task on the computer (copying a book for 15 minutes)
  • during the writing task, the muscle function of high trapezius muscles was evaluated by sEMG at minutes 1, 5, 10 and 15 for 30 seconds each time
• At the end of the study (1 week after the second evaluation) evaluation of pain intensity through NRS and of satisfaction for the treatment
• Final evaluation on the feasibility of a full-scale RCT through 14 methodological evaluations
• 1 session of OMT or sham treatment 20 minutes after the execution of the writing task
• OMT: evaluation and personalized treatment based on the participants
  • Techniques used: rotation harmonic technique for the all spine, soft tissue technique, inhibition, posterior-anterior thrust, traction with flexion and mobilization of the cervical spine
• Sham treatment: evaluation similar to OMT, but without diagnostic purposes, and light touch on bony prominences (acromion, clavicle, scapula, mastoid processes, lateral epicondyles, iliac spine, great trochanters, tibial tuberosity, lateral malleoli) for 1 minute
• No treatment: the participants reported to have practiced Pilates, postural awareness techniques, paracetamol, movement, stretching, heat, rest and change of position
• OMT and sham treatment performed by an osteopath with 10 years of clinical and academic experience
  participants were instructed not to consume alcohol or smoke for the 6 hours preceding data collection, and to avoid heavy meals and caffeine for 2 hours before data collection
• The group with no treatment was instructed not to receive any manual treatment during the study, in particular after the first writing task

Results

• Primary outcomes: the assessment of the feasibility of a full-scale RCT has been successful on all the parameters considered. In particular, it has been highlighted that sEMG was more a disturbing element than a useful outcome, as its results did not correlate to the validated instruments of pain measurement. Furthermore, it emerged that quality of life can be a useful outcome and that it would be good to have more staff to reduce bias related to the non-blindness of the practitioners (only the participants did not know which group they belonged to). No adverse effects were reported, except for a case of temporary muscle soreness
• Secondary outcomes: OMT favored the increase in pain threshold measured through PPT of both superior trapezius muscles and of the C7 vertebra in a statistically significant manner compared to sham treatment and no treatment, both in the immediate and 2-4 days after the intervention (with the exception of the evaluation of C7). A large effect size (the relevance of the effect obtained) was obtained with regard to the trapezius muscles and a medium one with regard to C7. There were no particularly different results between sham treatment and no treatment.
  Likewise, OMT favored a decrease in pain measured through NRS in both superior trapeziuses, both in the immediate and 2-4 days after the intervention and also after a further week. However, in the second follow-up OMT showed a statistically significant difference only against no treatment. In addition, while the effect size was large in the immediate, it was of little importance at the two follow-ups.
  As for muscle function, there were no differences in the immediate, however they emerged after 2-4 days, always in favor of OMT but only in the trapezius of the dominant hand and with an irrelevant effect size. Nevertheless, there was a difference in sham treatment compared to no treatment. The satisfaction questionnaire showed a general satisfaction of the participants, who, more than anything, did not fully appreciate the data collection and treatment location.

• further analysis: some significant corelations emerged, for example, between the level of education, the BMI, the type of computer used, age and sex, on one side, and the NRS and PPT values on the other side. Moreover, the NRS and PPT values resulted correlated to each other.

Discussion

The study showed that a large-scale RCT is feasible. However, further actions are needed, including using a location closer to a classic osteopathic practice, better checking that participants would not know what osteopathy is and would not recognize the treatment they have received, and remove the use of sEMG in favor of a questionnaire evaluating quality of life. OMT showed to be able to increase the pain threshold and decrease the perceived pain at the level of superior trapeziuses and C7 vertebra in a much better way than no treatment or sham treatment.

On the basis of these results, it is necessary to define a pilot study that would really serve as a baseline study for full-scale RCT.