A Phase 1 interventional study of massage in Massage Effect, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-05.
Sponsored by National Taiwan University Hospital · Phase 1, Interventional, and Treatment
The investigators investigated the effect and predictors of effectiveness of massage in the treatment of patients with posterior shoulder stiffness. This is a randomized controlled trial study- massage and control (hand touch) two times a week for 4 weeks. A total of 60 patients with posterior shoulder tightness were randomized into 2 groups; 52 of them completed this study (29 for the massage and 23 for the control). Patient sex, age, body mass index, glenohumeral internal rotation range of motion (ROM), duration of symptom, functional status, and muscle stiffness were recorded. Additionally, for the massage group, patients with glenohumeral internal rotation improvement of 20 degrees after massage were considered responsive, and the others were considered nonresponsive. The influences of the aftermentioned factors on the effectiveness of massage were analyzed by multivariate logistric regression. The overall mean internal rotation ROM increased significantly after massage (from 31.9° to 54.9°; P \< 0.001) compared to the control (from 28.7° to 34.9°; P > 0.05). There were 22 patients in the responsive group and 7 in the nonresponsive group. Among the factors, duration of symptoms, FLEX-SF score, and posterior deltoid stiffness were significant predictors of effectiveness of massage. Massage was an effective treatment for subjects with posterior shoulder stiffness, but was less effective in patients with longer duration of symptoms, higher functional limitation, and less posterior deltoid stiffness.
National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
The inclusion criteria of patients with glenohumeral internal rotation limitation and posterior shoulder stiffness were: \[1\] limitation of internal rotation ROM compared to the sound side; \[2\] mild glenohumeral joint hypomobility according to joint play assessment; \[3\] stiffness in the posterior shoulder region.
Other: massage
Other: massage
For the massage group, a physical therapist with 8 years of clinical experience in manual therapy provided the massage on the posterior deltoid, infraspinatus, and teres minor of the involved shoulder for 18 minutes \[about 6 minutes for each muscle and order was random\] two times a week for 4 weeks. The techniques of massage included petrissage for 3 minutes and rolling for 3 minutes of soft tissues
Range of Motion
Time frame: pre and post-massage
muscle stiffness
Time frame: pre and post-massage
functional disability
Time frame: pre and post-massage
This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital