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

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

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Other: massage

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: massage group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	In order to determine whether subjects had any improvement in their range of motion (ROM) investigators will measure their hip and knee joint (if applicable). Investigators will use a standard 12 inch plastic goniometer to measure and record the angles at each joint. The specific goniometer was manufactured by Ever Ready First Aid Medical Supply Corp. in Brooklyn, NY. This tool can measure up to 360 degrees in 1 degree increments and has been calibrated according to the International Standards of Measurement.	Change in range of motion as measured by goniometer between baseline and study completion at the fourth week (Visit 4).
Muscle strength	Regarding muscle strength, investigators will perform a Manual Muscle Test (MMT) according to the 9th edition of Daniels & Worthington's Muscle Testing. The specific techniques described in this text focus the MMT on joint movements rather than individual muscles (for example knee extension vs. rectus femoris). The most common procedure is called the break test, in which the limb is placed and held at the end of the available range (for one-joint muscles) or at mid-range (for two-joint muscles) and manual resistance is applied by the therapist in the direction of the line of pull of the muscle(s) being tested. A numerical and qualitative score is then assigned to the muscle(s) ranging from 5: Normal (N) to 0: No activity (0).	Change in muscle strength score as measured by the MMT between baseline and study completion at the fourth week (Visit 4).

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Heather Appling, MSOP, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): June 16, 2018
• Study Completion (Actual): June 16, 2018

Study Registration Dates

• First Submitted: December 13, 2017
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 24, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 5170458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No