AmputationNCT03389334
Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees
A study testing massage in people with Amputation, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2018to 16 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change in visual analog pain scale score between baseline and study completion at the fourth week (Visit 4).
Secondary outcomes (2)
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.
Measured: 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).
Measured: Change in muscle strength score as measured by the MMT between baseline and study completion at the fourth week (Visit 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start29 Mar 2018
- Primary completion16 Jun 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Appling, Loma Linda University
- Investigators
- Heather Appling, MSOP, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389334
- Sponsor's protocol ID
- 5170458
- Status last verified
- Sep 2018
- First submitted
- 13 Dec 2017
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Myofascial Release Massage on Pain Levels, Range of Motion, and Muscle Strength in Unilateral Lower Limb Amputees
- ClinicalTrials.gov ID
- NCT03389334
- Acronym / sponsor ID
- 5170458
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 3 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| massage group | Experimental | Other: massageSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Open wounds within the treatment area
- Bilateral lower limb amputees
- Pregnant subjects (self-reported)
- Lymphedema
- Amputation distal to ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massageThe 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. | Other | massage group |
Primary outcome
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.
2 secondary outcomes
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Appling, MSOP principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage in people with Amputation, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Back Pain (time frame: Change in low back pain between baseline and study completion at the fourth week (Visit 4).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.