Real Versus Sham Manual Therapy for RCRSP

Study Overview
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Brief Summary
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A convenience sample of subjects with RCRSP recruited through announcements at the Benemerita Universidad Autonoma de Puebla will be treated with an exercise program with sham or real manual therapy for 5 weeks. The hypothesis of the present study is that the addition of manual therapy to a therapeutic exercise program produces better benefits in comparison to the same exercise program with sham manual therapy procedures in the management of patients with RCRSP.

Detailed Description
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The objective of this study is to demonstrate that the combination of manual therapy and therapeutic exercise achieves better results in the management of the patient with shoulder pain. For this, manual therapy techniques in the thoracic region and in the shoulder together with a therapeutic exercise program will be applied. The investigators will compare this intervention protocol with placebo manual therapy techniques and the same therapeutic exercise protocol.

Official Title
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Real Versus Sham Manual Therapy in Addition to Therapeutic Exercise in the Treatment of Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Manual therapy thoracic spine
* Other: Manual therapy glenohumeral joint
* Other: Sham thoracic manual therapy
* Other: Sham glenohumeral manual therapy
* Other: Therapeutic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral shoulder pain of non-traumatic origing lasting more than three months. Pain evoked with active shoulder movements. Pain and weakness evoked with manual muscle strength tests for abduction and/or external rotation. Minimal or no rest pain (less than 3 points in a numeric pain rating scale). Exclusion Criteria: Other shoulder pathologies than RCRSP. Systemic diseases. Neural symptoms. Neck pain. Radiculopathy. To have been treated for shoulder pain in the last three months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real manual therapy<br>Real manual therapy directed to the thoracic spine and glenohumeral joint added to a therapeutic exercise program | Other: Manual therapy thoracic spine<br>* Manual therapy mobilization directed to the costovertebral joint.<br>Other: Manual therapy glenohumeral joint<br>* Manual therapy mobilization directed to the glenohumeral joint.<br>Other: Therapeutic exercise<br>* Therapeutic exercise program consisting on isometric exercise with progressive load.<br>|
| Sham Comparator: Sham thoracic manual therapy<br>Sham manual therapy directed to the thoracic spine with real manual therapy directed to the glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group | Other: Manual therapy glenohumeral joint<br>* Manual therapy mobilization directed to the glenohumeral joint.<br>Other: Sham thoracic manual therapy<br>* Sham manual therapy directed to the costovertebral joint.<br>Other: Therapeutic exercise<br>* Therapeutic exercise program consisting on isometric exercise with progressive load.<br>|
| Sham Comparator: Sham manual therapy<br>Sham manual therapy directed to the thoracic spine and glenohumeral joint added to the same therapeutic exercise program performed in the real manual therapy group | Other: Sham thoracic manual therapy<br>* Sham manual therapy directed to the costovertebral joint.<br>Other: Sham glenohumeral manual therapy<br>* Sham manual therapy directed to the glenohumeral joint.<br>Other: Therapeutic exercise<br>* Therapeutic exercise program consisting on isometric exercise with progressive load.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain and Disability Index (SPADI) | The SPADI points from 0 (no disability) to 130 (maximum degree of disability) | Change from Baseline at 17- week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured with a visual analogue scale | 10-cm scale where 0 is no pain and 10 is the worst pain imaginable | Change from Baseline at 17-week | 
| Pain-free range of movement of the shoulder | Flexion, extension, abduction, internal rotation and external rotation measured with a two-arm goniometer | Change from Baseline at 17-week |