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

Complex Regional Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03111225
• Other study ID #: 2016-2
• Status: Completed
• Phase: N/A
• Start date: June 6, 2016
• Est. completion date: September 17, 2017

Study information

• Verified date: September 2019
• Source: Reuth Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 17, 2017
• Est. primary completion date: September 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complex Regional Pain Syndromes
• Reflex Sympathetic Dystrophy
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Israel	Reuth Rehabilitation Hospital	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Reuth Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	Questionnaire that examines upper limb function	10 minutes
Secondary	Goniometer	shoulder flexion range of motion	1 minute
Secondary	CRPS severity score (CSS)	form filled by an MD after an interview and examination of a patient	20 minutes
Secondary	skin rolling test		1 minute
Secondary	trigger point examination		5 minutes
Secondary	NPRS	Numerical Pain Rating Scale	1 minute
Secondary	Pressure algometer	pressure pain threshold	10 minutes
Secondary	Allodynia in scapula, arm and forearm	von Frey filaments	5 minutes