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

NCT03389334 | Completed

• 1 other identifier: 5170458
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (2)

• Low Back Pain

  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.

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

• visual analog pain scale

  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.

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

Secondary Outcomes (2)

• Range of Motion

  Change in range of motion as measured by goniometer between baseline and study completion at the fourth week (Visit 4).

• Muscle strength

  Change in muscle strength score as measured by the MMT between baseline and study completion at the fourth week (Visit 4).

Study Arms (1)

massage group

EXPERIMENTAL

Subjects will complete the SF-36, ODI, demographics surveys and then will receive pre-treatment range of motion, muscle strength and visual analogue pain scale prior to massage. Then will have a 45-minute myofascial release massage. Then they will fill out the visual analogue pain scale again. (Approximately 90-minutes) The second and third visits: visual analogue scale prior to the treatment; 45-minute massage, by the same therapist who treated them during the initial visit, and will fill out a second visual analog pain scale following the treatment. (Approximately 60-minutes) The fourth visit: visual analogue pain scale and 45-minute massage; post-treatment SF-36, ODI surveys, visual analogue pain scale, post-treatment range of motion and muscle strength.

Other: massage

Interventions

massage OTHER

The techniques include myofascial release and manual active and passive stretching with the intention to lengthen overly contracted or shortened tissue, increase range of motion, and restore any malpositioning of structural landmarks as defined by its contralateral counterpart. By addressing the symptoms of the somatic dysfunction, you will in turn reduce the overall perceived pain in the body caused in these related tissues. The duration of each massage treatment session will be 45 minutes long and therapists will use a timer to ensure all subjects receive the same length of treatment. Patients will continue to receive treatment from the same therapist to maintain consistency of results.

massage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Universtiy

Loma Linda, California, 92350, United States

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Heather Appling, MSOP

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Orthotics and Prosthetics

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 3, 2018
• Study Start: March 29, 2018
• Primary Completion: June 16, 2018
• Study Completion: June 16, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)