OBJECTIVE: To compare the effectiveness of intratissue percutaneous microelectrolysis (IPM) in addition to shoulder exercise program on pain intensity and disability in individuals with rotator cuff tendinopathy.
STUDY DESIGN: Two parallel arms, single-blind superiority randomized controlled trial. SITE: Outpatient clinic (Alcides Carneiro University Hospital).
PARTICIPANTS: Forty-two individuals with rotator cuff tendinopathy were randomly allocated (1:1) into 2 groups: IPM associated with exercises (IPM+Ex) and exercises only (Ex).
INTERVENTIONS: Both groups underwent a therapeutic exercise program (6 in-person sessions) conducted by a physiotherapist, but only the IPM+Ex group received additional treatment with IPM (6 sessions). Linear mixed models were used to compare groups.
MAIN OUTCOME MEASURES: Pain intensity was measured with the Numerical Pain Rating Scale and shoulder disability with the Shoulder Pain and Disability Index. The outcomes were evaluated (blinded assessor) at baseline and 8 weeks after the intervention protocol. The secondary outcomes included adverse effects, frequency of the weekly home exercises, and overall perceived effect.
RESULTS: Forty individuals completed the 8-week follow-up. There were statistically significant within-group changes in both IPM+Ex and Ex for pain (IPM+Ex: mean difference -3.19; 95% CI: -4.45 to -1.94; Ex: mean difference: -3.99; 95% CI: -5.27 to -2.72) and disability (IPM+Ex: mean difference -35.76; 95% CI: -47.77 to -23.76; Ex: mean difference: -38.26; 95% CI: -50.45 to -26.07). We found no between-group significant differences in either pain (mean difference: -1.23; 95% CI: -2.54, 0.07) or disability (mean difference 7.17; 95% CI: -7.02, 21.35). We found no differences between the groups (P<.05) regarding adverse effects, frequency of the weekly home exercises, and overall perceived effect.
CONCLUSION: Applying IPM along with therapeutic exercises does not have additional effects on pain intensity and disability in individuals with rotator cuff tendinopathy.
| Discipline Area | Score |
|---|---|
| Rehab Clinician (OT/PT) |  |
| Physician |  |
Rehab Clinician (OT/PT) rater
Useful to know that exercise remains the most effective intervention.
Rehab Clinician (OT/PT) rater
The key strengths are: 1. this study was registered prospectively; 2. adhered to the CONSORT guidelines; 3. the assessors were blinded; and 4. the intervention protocol was based on shoulder exercises and intratissue percutaneous microelectrolysis (IPM) that is feasible for clinical practice. However, applying IPM along with therapeutic exercises does not have additional effects on pain intensity and disability in individuals with rotator cuff tendinopathy. Therefore, these results may represent the clinical responses encountered by physical therapists in the treatment of pain and disability related to chronic rotator cuff tendinopathy.
Rehab Clinician (OT/PT) rater
This clinical trial was under-powered to detect a minimally clinically important difference (MCID) of between-group mean pain difference of 1.1. The between-group mean pain difference was -1.23 but the 95% CI was wide, -2.54 to 0.07, as shown in Table 2. The point estimate of primary outcome exceeded the MCID, implying inadequate sample size for detecting a difference favoring the intervention group! Paradoxically, the between-group mean pain difference should be 0.80 rather than 1.23 according to the “time effect” (-3.99 vs -3.19)! Were there any typos?
, McMaster University