Clinical trial NCT03111225: Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome
Official title: Thoracic Paraspinal Soft Tissue Mobilizations in Treatment of Patients With Upper Limb Complex Regional Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complex Regional Pain Syndromes
Lead sponsor: Reuth Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The observation stage is a case- control study, the treatment stage is an A-B-A design.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: Goniometer
timeFrame: 1 minute
measure: CRPS severity score (CSS)
timeFrame: 20 minutes
measure: skin rolling test
timeFrame: 1 minute
measure: trigger point examination
timeFrame: 5 minutes
measure: NPRS
timeFrame: 1 minute
measure: Pressure algometer
timeFrame: 10 minutes
measure: Allodynia in scapula, arm and forearm
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Reuth Rehabilitation Hospital
Study officials:
affiliation: Reuth Rehabilitation Hospital
name: Jean-Jeaques Vatine, Prof
role: PRINCIPAL_INVESTIGATOR
References: