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

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 Overview

• Status: Completed
• Conditions: Complex Regional Pain Syndromes
• Intervention / Treatment: Diagnostic test: massage

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.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Reuth Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: massage; a 15 minutes thoracic massage will be added to the regular physical therapy treatment
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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Reuth Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2016
• Primary Completion (Actual): September 17, 2017
• Study Completion (Actual): September 17, 2017

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2019
• Last Update Submitted That Met QC Criteria: September 5, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Autonomic Nervous System Diseases; Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Somatoform Disorders
• Other Study ID Numbers: 2016-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No