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Completed

NCT Number: NCT03389334

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.

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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda Universtiy

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. Range of Motion

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

    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.

  2. Muscle strength

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

    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).

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 3, 2018
Registry last updated
Sep 25, 2018

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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