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

NCT ID: NCT03111225

Last Updated: 2019-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-06

Study Completion Date

2017-09-17

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.

Conditions

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Complex Regional Pain Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The observation stage is a case- control study, the treatment stage is an A-B-A design.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

massage

Intervention Type DIAGNOSTIC_TEST

a 15 minutes thoracic massage will be added to the regular physical therapy treatment

healthy controls

healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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massage

a 15 minutes thoracic massage will be added to the regular physical therapy treatment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reuth Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Reuth Research Institute

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Jeaques Vatine, Prof

Role: PRINCIPAL_INVESTIGATOR

Reuth Rehabilitation Hospital

Locations

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Reuth Rehabilitation Hospital

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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2016-2

Identifier Type: -

Identifier Source: org_study_id

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