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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 17, 2017

Detailed Description

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.

Interventions

  • Diagnostic Test: massage
    • a 15 minutes thoracic massage will be added to the regular physical therapy treatment

Arms, Groups and Cohorts

  • Experimental: CRPS patients
    • 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.
  • No Intervention: healthy controls
    • healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)

Clinical Trial Outcome Measures

Primary Measures

  • Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
    • Time Frame: 10 minutes
    • Questionnaire that examines upper limb function

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Reuth Rehabilitation Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Reuth Research Institute, Professor – Reuth Rehabilitation Hospital
  • Overall Official(s)
    • Jean-Jeaques Vatine, Prof, Principal Investigator, Reuth Rehabilitation Hospital

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