Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial

Participants

• Number: 70 people (39 female and 31 male, mean age 45.6 years).

• Criteria of inclusion: adults (age between 25 and 70 years), duration of shoulder pain (pain localized around: glenohumeral joint, acromioclavicular joint, sternoclavicular joint or scapulothoracic connections) between 6 weeks and 12 months, pain intensity during the week prior to recruitment of at least 40% on VAS.
• Criteria of exclusion: shoulder or chest operation; shoulder, sternum, or clavicle fracture; shoulder dislocation during the past 6 months; adhesive capsulitis or frozen shoulder; rotator cuff rupture; rheumatoid arthritis; peripheral paralysis of the upper extremities; acute inflammatory processes; neoplasms; central nervous system disorders; osteoarthritis at the shoulder joints of the 3rd or 4th degree.

• Groups of study: 2 groups obtained by randomization (stratified on the basis of the practitioner who applied OMT)
  • Group 1: OMT, 36 people (20 female and 16 male, mean age 45.7 years).
  • Gruppo 2: OMT, 36 people (20 female and 16 male, mean age 45.7 years).
  • Participants were recruited in various ways and knew they would receive osteopathic treatments.

Interventions and evaluations

• Assessment of worst pain intensity and average pain experienced the previous week by VAS (0 = no pain; 100 = worst possible pain), pain frequency by Likert scale (5 choices, ie, never, rarely, occasionally, often, always), and shoulder-specific pain and disability by SPADI.
  • The OMT group was evaluated at the beginning of each visit, 2 weeks after the last visit, and after another 8 weeks.
  • The control group was evaluated at the first visit and after 8 weeks.
• Evaluation of Quality of Life through questionnaire SF-36.
  • The OMT group was evaluated at the first visit, at week 4, at week 10, and after another 8 weeks.
  • The control group was evaluated at the first visit and after 8 weeks.
• Five fortnightly OMT sessions of 40-60 minutes.
• OMT: standardized osteopathic assessment looking for somatic dysfunction to define personalized treatment
  • The practitioners applied the techniques they deemed appropriate for each of the patients
• Waiting list: during the study, people did not receive any treatment. Only after 8 weeks, once the OMT group had finished receiving treatments, did people in the control group receive OMT.
• OMT performed by 3 osteopaths (Heilpraktiker with 6 years of osteopathic studies with final clinical examination).
• Participants were allowed to use medication to manage shoulder pain when needed.

Results

• Primary outcomes: while the control group showed no differences between the beginning and the end of the study, the OMT group showed a statistically significant reduction in pain (both maximum and average pain experienced the previous week) between the first and last sessions. In the follow-up period, the OMT group showed a continuous trend of decreasing pain.
  Regarding pain frequency, in the OMT group 33 participants experienced some improvement, while 3 participants showed no change at all. In the control group, on the other hand, only 8 participants experienced some improvement, while 26 showed no change. These different results between OMT group and control group were  statistically significant.
• Secondary outcomes: pain and disability specific to the shoulder, measured by SPADI were found to have decreased statistically significantly for the OMT group both between the first and last sessions and in comparison with the control group.
  Regarding the physical component (eg, pain, daily activities) of quality of life, both groups witnessed a statistically significant improvement of it, although the improvement was greater in the OMT group. There were no differences in relation to the mental component (eg, stress levels) between the two groups.
• Further analyses: the reduction in pain intensity was evaluated for each of the 3 osteopaths. This analysis showed that the 3 osteopaths induced the same decrease in shoulder pain in their patients.
  Osteopathic evaluation found somatic dysfunction mainly at the level of the respiratory diaphragm (70% of participants), the dorsal spine (67% of participants), and the glenohumeral and acromioclavicular joints. No adverse effects emerged during the study other than some fatigue reported occasionally on the day of treatment.

Discussion

OMT induced statistically but mostly clinically significant improvements in shoulder pain. Such improvements persisted also after the end of the study with a positive trend. The SPADI and SF-36 confirmed the results obtained by simple pain assessment, thus reinforcing the usefulness of an osteopathic approach based on promoting health and not  on suppressing symptoms so much.

The stratified analysis on the 3 osteopaths showed homogeneity in their approach and effectiveness.

The control group saw pain continue throughout the 8 weeks of the study, reflecting the chronicity of the problem and confirming the choice of good inclusion and exclusion criteria. In fact, the age and duration limits in relation to pain made it possible to exclude possible confounding factors: for example, people with possible age-related joint degeneration or acute pain that might have spontaneously changed during the study, thus altering the results (eg, bias of regression to the mean). A negative effect of being on a waiting list can then be ruled out, as participants were already scheduled for free osteopathic visits at the end of the study.

Unfortunately, it was not possible to adequately collect the medications used by the participants during the study. In addition, since participants wanted to receive osteopathic treatment themselves, effects due to expectations (although this is an effect peculiar to actual clinical practice), or “confirmation bias”, in achieving pain reduction cannot be ruled out.