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Clinical Trials/NCT03389334
NCT03389334
Completed
Not Applicable

Effects of Myofascial Release Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees

Loma Linda University1 site in 1 country7 target enrollmentMarch 29, 2018
ConditionsAmputation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation
Sponsor
Loma Linda University
Enrollment
7
Locations
1
Primary Endpoint
Low Back Pain
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this graduate research study is to explore the therapeutic benefits of Myofascial Release massage on lower limb amputees with pain levels, range of motion, and muscle strength.

Detailed Description

There are no other studies that address the effects of massage therapy as a treatment option for lower limb amputees suffering from lower back pain or the effects this has on muscle performance and/or range of motion. In addressing the physical, psychological, and social needs of a person living with limb loss, there should be a consideration for a multidisciplinary approach that could potentially include massage therapy as a fundamental standard of care. Therefore, the purpose of this graduate student research study is to test whether myofascial release massage can improve lower back pain levels in lower limb amputees and consequently improve quality of life and other measurable variables such as range of motion and muscle strength.

Registry
clinicaltrials.gov
Start Date
March 29, 2018
End Date
June 16, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heather Appling

Assistant Professor Department of Orthotics and Prosthetics

Loma Linda University

Eligibility Criteria

Inclusion Criteria

  • Pain in the lower back region
  • Trans-tibial, trans-femoral, knee disarticulation, or Symes amputees
  • Unilateral lower limb amputation
  • Subject willing to receive massage once a week over a 4 week span
  • Subject must be willing to abstain from over-the-counter and prescription pain medication 24 hours before each treatment

Exclusion Criteria

  • Open wounds within the treatment area
  • Bilateral lower limb amputees
  • Pregnant subjects (self-reported)
  • Lymphedema
  • Amputation distal to ankle
  • Subjects who currently receive regular massage treatments
  • Subjects taking anticoagulant medication
  • Subjects with allergies to coconut oil

Outcomes

Primary Outcomes

Low Back Pain

Time Frame: Change in low back pain between baseline and study completion at the fourth week (Visit 4).

Subject's lower back pain data will be collected through the Owestry Disability Index (ODI). It is valid and reliable in a variety of settings . Patients select statements that are most applicable to their current situation in the following areas: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function (if applicable), ability to stand, social life, sleep quality, and ability to travel. The questionnaire will take less than 5 minutes. Questionnaire is given at the beginning of the study and then will be compared with the responses after the 4 week treatment.

visual analog pain scale

Time Frame: Change in visual analog pain scale score between baseline and study completion at the fourth week (Visit 4).

A Visual Analog Scale, consisting of a 10 cm long horizontal line which represents various levels of pain with "No Pain" at one end and "Unbearable Pain" at the other will be given.

Secondary Outcomes

  • Muscle strength(Change in muscle strength score as measured by the MMT between baseline and study completion at the fourth week (Visit 4).)
  • Range of Motion(Change in range of motion as measured by goniometer between baseline and study completion at the fourth week (Visit 4).)

Study Sites (1)

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