- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05158556
Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization in Lumbar Region
Gender Based Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization on Trigger Points in Lumbar Region
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Trigger points are hyper-irritable points, appear as nodules on palpation, discrete and focal spots in the taut band of skeletal muscles. Usually these points are sensitive to pressure, if direct compression is applied over them, that can evoke jump sign, tenderness and pain is produced locally but it is referred to surrounding areas. There are many types of trigger points on the basis of location, chronicity and tenderness. They are classified as central, satellite, diffuse, inactive,and active. The trigger points can be developed by repetitive overuse injuries or sustained loading like lifting heavy weight, carrying babies, bags, briefcase etc. It can also be manifested by poor posture or prolonged period of inactivity such as bed rest or sitting causing pain, reduced range of motion, muscle tightness. When there are number of trigger points in muscles causing micro-cramps resulting in myofascial pain syndrome. Trigger points are the areas of contracted muscles causing restriction of in blood flow within the tissues. She claimed that by applying sustained pressure over trigger points with thumbs, knuckles and elbow followed by stretching of the muscle produced much better results compared to trigger point injections. Myofascial trigger points in lumbar region play an important role in genesis of mechanical low back pain. The hyper-irritable spots usually present within the taut band of skeletal muscles which on compression can give rise to characteristics like; referred pain, autonomic phenomena like (sweating, vasoconstriction and pilomotor activity) and motor dysfunction. It is essential to inquire the gender differences in pain perception level because many diseases like migraine, rheumatoid arthritis, and low back pain are more common among females than males. Females not only report more pain but they also experience more intense pain in their body parts as compared to males. Factors like psychological and physiological contribute in difference in pain perception among females and male. A study suggests that females show greater perception towards pain threshold as compared to males.
Myofascial release technique is usually considered as alternative of medicine therapy highly recommended to treat immobility of skeletal muscles and pain by improving blood circulation and oxygen in these muscles and is non-invasive method. Moreover, it produces stretch reflex in muscles. By applying sustained pressure for 30 seconds over the trigger points until the patient's pain intensity is decreased considerably. As this pressure applied would help to break the adhesive fibres connection within the muscle helping to push out the blood containing waste products and toxins because after 30 seconds fresh blood containing nutrients will flow and trigger points are released.
Instrument assisted soft tissue mobilization (IASTM) is also a professional practice to treat soft tissues. Moreover, IASTM mainly decreases pain sensitivity and pain threshold of myofascial trigger points. It is applied by using the instrument made up of stainless steel with edges and contours according to different body locations allowing deeper penetration treating soft tissue disorders. Instrument assisted soft tissue mobilization is master intervention using specialized tool to manipulate the skin , muscles, myofascial, tendons by various direct compressive strokes. IASTM technique is very effective as it effectively break the restrictions in fascia and scar tissue. Adhesions may developed within the soft tissue after surgery, immobilization, strain, are broken down by using this instrument allowing full restoration of function.
The tool I am using in my study for instrument assisted soft tissue mobilization technique is M2T Blade technique is a multifunctional instrument invented by Adam Broger consisting of many planes and is very effective in treating pain and spasm. M2T Blade is a new invention and it is beneficial in reducing myofascial pain. Its efficacy is proven over soft tissues that it releases fascial tightness. Moreover it also improves range of motion of a joint. Highly loaded blades are designed to provide a specific distribution is given. The three-dimensional analysis methodology is used here.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Rawalpindi, Punjab, Pakistan, 43600
- Muzaffar Khan Surgical Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with at least one active trigger point in lumbar region.
- Office workers sitting in office > 5 hours a day.
- Targeting both deep and superficial muscles.
Exclusion Criteria:
- History of spinal surgeries
- Trauma
- Acute Fractures
- Tuberculosis spine
- Wounds, Infections or any other cause of back pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: myofascial release technique
Myofascial Release Technique will be applied with forearm/ ulnar border of palm.
deep pressure will be applied and glided medially towards the thoraco-lumbar region.ins
|
Myofascial Release Technique will be applied with forearm/ ulnar border of palm.
Deep pressure will be applied and glided medially towards the thoraco-lumbar region.
instrument assisted soft tissue mobilization is done via M2T Blade. it is a multifunctional instrument consisting of many planes and is very effective in treating pain and spasm.
Its efficacy is proven over soft tissues that it releases fascial tightness.
|
Experimental: Instrument Assisted Soft Tissue Mobilization
instrument assisted soft tissue mobilization is done via M2T Blade. it is a multifunctional instrument consisting of many planes and is very effective in treating pain and spasm.
Its efficacy is proven over soft tissues that it releases fascial tightness.
|
Myofascial Release Technique will be applied with forearm/ ulnar border of palm.
Deep pressure will be applied and glided medially towards the thoraco-lumbar region.
instrument assisted soft tissue mobilization is done via M2T Blade. it is a multifunctional instrument consisting of many planes and is very effective in treating pain and spasm.
Its efficacy is proven over soft tissues that it releases fascial tightness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: for 6 weeks
|
Numeric Pain Rating Scale is an 11 point tool used to assess the pain intensity among people.
Its value ranges from 0 to 10, where 0 means no pain and 10 means worst possible pain.
It is a reliable and valid tool (r=0.96, its validity correlations range from 0.86 to 0.95.Assesment was performed at the base line and after 6-weeks.
|
for 6 weeks
|
Pain Sensitivity Questionnaire
Time Frame: for 6 weeks
|
Pain sensitivity questionnaire is a valid and reliable tool used to measure pain perception in different populations.
Cronbach's alpha value for the Pain Sensitivity Questionnaire was 0.92.
Assesment was performed at the base line and after 6-weeks.
|
for 6 weeks
|
inclinometer
Time Frame: for 6 weeks
|
An inclinometer is a device used by physical therapist to measure range of motion for spinal posture.
An inclinometer gives more accurate, precise and reproducible Range of motion measurements than goniometer.
It is a reliable and valid tool r=0.93, validity=0.92.
Assesment was performed at the base line and after 6-weeks.
|
for 6 weeks
|
Modified Somatic Perception Questionnaire
Time Frame: for 6 weeks
|
Modified Somatic Perception Questionnaire is a self-report scale consists of 13 items.
It helps to find out the complaints that are associated with psychological responses.
The scale has ICC value 0.72.
Assesment was performed at the base line and after 6-weeks.
|
for 6 weeks
|
algometer
Time Frame: for 6 weeks
|
Algometer is a reliable and valid tool used to measure the pressure pain threshold.
intraclass correlation coefficient value =0.91.
Assesment was performed at the base line and after 6-weeks.
|
for 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Maria khalid, MS-OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-00936 Irum Nosheen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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