- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01022827
Shoulder Muscle Massage Shoulder Stiffness
January 3, 2012 updated by: National Taiwan University Hospital
Effects and Predictors of Effectiveness of Shoulder Muscle Massage for Patients With Posterior Shoulder Stiffness
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a limited ROM of internal rotation (internal rotation ROM < 20% to the sound side), and
- pain and stiffness in the shoulder region for at least 3 months.
Exclusion Criteria:
- surgery on the particular shoulder,
- rheumatoid arthritis,
- stroke with residual shoulder involvement,
- fracture of the shoulder complex,
- rotator cuff deficiency, and
- resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: posterior shoulder stiffness massage group
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.
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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
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Placebo Comparator: posterior shoulder stiffness placebo group
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Range of Motion
Time Frame: pre and post-massage
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pre and post-massage
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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muscle stiffness
Time Frame: pre and post-massage
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pre and post-massage
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functional disability
Time Frame: pre and post-massage
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pre and post-massage
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jiu-jenq Lin, PhD, School of Physical Therapy, National Taiwan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 30, 2009
First Posted (Estimate)
December 1, 2009
Study Record Updates
Last Update Posted (Estimate)
January 5, 2012
Last Update Submitted That Met QC Criteria
January 3, 2012
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 200905041R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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