Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome

Study Overview
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Brief Summary
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This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.

Detailed Description
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This study examines the prevalence of trigger points in muscles in the thorax in upper limb Complex Regional Pain Syndrome (CRPS) patients, compared to healthy subjects. The muscles that will be examined are: Subclavius, Pectoralis minor, Rhomboids, Infraspinatus and Serratus superior posterior. In addition, we will examine if adding treatment to muscles in the thoracic area (to the regular physical therapy treatment) will alleviate some of the sensitivity in the upper limb in CRPS patients.This will be examined in an A-B-A design: at first the patients will be examined. Then they will recieve conventional physiotherapy treatment for a month. After a month, they will be examined again, and then they will recieve soft tissue massage to the thoracic area for 15 minutes in addition to the conventional physiotherapy treatment. After a month of the combined treatment, the patients will be examined a third and final time.

Official Title
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Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome

Conditions
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Complex Regional Pain Syndromes

Intervention / Treatment
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* Diagnostic Test: massage


Participation Criteria
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Eligibility Criteria
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Inclusions Criteria for cases in stage 1 and all subjects of stage 2: Age between 18-70 CRPS diagnosed by board certified specialist in rehabilitation or pain medicine Constant chronic pain for ≥six months preceding the trial; Spontaneous pain in a day of first evaluation (numeric pain rating scale (NPRS) ≥4/10) Stimulated pain is not attributable to other causes, such as peripheral inflammation. Inclusions Criteria for controls in stage 1: Age between 18-70 Do not suffer from any medical issues or chronic pain Exclusion criteria for all subjects in stages 1 and 2: Tumors Participation in another interventional clinical trial. History of major psychiatric or neurological illness (like stroke). Rheumatoid arthritis or other major rheumatologic disorders. Fibromyalgia or any other systemic illness. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The observation stage is a case- control study, the treatment stage is an A-B-A design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRPS patients<br>CRPS patients that will be examined for trigger points in the thoracic muscles. 10 out of the 23 will also be included in the intervention stage and will recieve a month of conventional physiotherapy, and a month of conventional physiotherapy with addition of massage to the thoracic area. | Diagnostic Test: massage<br>* a 15 minutes thoracic massage will be added to the regular physical therapy treatment<br>|
| No Intervention: healthy controls<br>healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire | Questionnaire that examines upper limb function | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goniometer | shoulder flexion range of motion | 1 minute | 
| CRPS severity score (CSS) | form filled by an MD after an interview and examination of a patient | 20 minutes | 
| skin rolling test |  | 1 minute | 
| trigger point examination |  | 5 minutes | 
| NPRS | Numerical Pain Rating Scale | 1 minute | 
| Pressure algometer | pressure pain threshold | 10 minutes | 
| Allodynia in scapula, arm and forearm | von Frey filaments | 5 minutes |