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Completed

NCT Number: NCT03111225

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reuth Rehabilitation Hospital

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

massage

Diagnostic Test

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

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

    Time frame: 10 minutes

    Questionnaire that examines upper limb function

Secondary outcomes

  1. Goniometer

    Time frame: 1 minute

    shoulder flexion range of motion

  2. CRPS severity score (CSS)

    Time frame: 20 minutes

    form filled by an MD after an interview and examination of a patient

  3. skin rolling test

    Time frame: 1 minute

  4. trigger point examination

    Time frame: 5 minutes

  5. NPRS

    Time frame: 1 minute

    Numerical Pain Rating Scale

  6. Pressure algometer

    Time frame: 10 minutes

    pressure pain threshold

  7. Allodynia in scapula, arm and forearm

    Time frame: 5 minutes

    von Frey filaments

Sponsors and collaborators

Lead sponsor

Reuth Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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