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

Primary Purpose

Complex Regional Pain Syndromes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
massage
Sponsored by
Reuth Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndromes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Reuth Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CRPS patients

healthy controls

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Questionnaire that examines upper limb function

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2017
Last Updated
September 5, 2019
Sponsor
Reuth Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03111225
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2016 (Actual)
Primary Completion Date
September 17, 2017 (Actual)
Study Completion Date
September 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reuth Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The observation stage is a case- control study, the treatment stage is an A-B-A design.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CRPS patients
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy controls
Arm Type
No Intervention
Arm Description
healthy controls that will be examined for trigger points in the thoracic muscles (and will be compared to the CRPS patients)
Intervention Type
Diagnostic Test
Intervention Name(s)
massage
Intervention Description
a 15 minutes thoracic massage will be added to the regular physical therapy treatment
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
Questionnaire that examines upper limb function
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Goniometer
Description
shoulder flexion range of motion
Time Frame
1 minute
Title
CRPS severity score (CSS)
Description
form filled by an MD after an interview and examination of a patient
Time Frame
20 minutes
Title
skin rolling test
Time Frame
1 minute
Title
trigger point examination
Time Frame
5 minutes
Title
NPRS
Description
Numerical Pain Rating Scale
Time Frame
1 minute
Title
Pressure algometer
Description
pressure pain threshold
Time Frame
10 minutes
Title
Allodynia in scapula, arm and forearm
Description
von Frey filaments
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jeaques Vatine, Prof
Organizational Affiliation
Reuth Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reuth Rehabilitation Hospital
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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

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