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

NCT ID: NCT03389334

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2018-06-16

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.

Conditions

Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

massage

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Heather Appling

Assistant Professor Department of Orthotics and Prosthetics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Appling, MSOP

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda Universtiy

Loma Linda, California, United States

Countries

United States

Other Identifiers

5170458

Identifier Type: -

Identifier Source: org_study_id