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Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization in Lumbar Region

Primary Purpose

Trigger Point Pain, Myofascial

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial Release Technique
Instrument Assisted Soft tissue Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial focused on measuring trigger point,, myofascial release, instrument assisted soft tissue mobilization, range of motion, pain

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Muzaffar Khan Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

myofascial release technique

Instrument Assisted Soft Tissue Mobilization

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale
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.
Pain Sensitivity Questionnaire
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.
inclinometer
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.
Modified Somatic Perception Questionnaire
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.
algometer
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.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2021
Last Updated
March 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05158556
Brief Title
Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization in Lumbar Region
Official Title
Gender Based Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization on Trigger Points in Lumbar Region
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
January 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Trigger point are hyper-irritable points, appear as nodules on palpation, discrete and focal spots in the taut band of skeletal muscles. Myofascial release technique and instrument assisted soft tissue mobilization both techniques are used to break the adhesions and mobilize the soft tissue, releasing the trigger points. The study will contribute in comparing the level of pain threshold perceived by males and females in our society. .Moreover, finding a noninvasive effective treatment that is non-exhaustive for the therapist and non-painful for the patient.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Point Pain, Myofascial
Keywords
trigger point,, myofascial release, instrument assisted soft tissue mobilization, range of motion, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myofascial release technique
Arm Type
Experimental
Arm Description
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
Arm Title
Instrument Assisted Soft Tissue Mobilization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Release Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Instrument Assisted Soft tissue Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
for 6 weeks
Title
Pain Sensitivity Questionnaire
Description
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.
Time Frame
for 6 weeks
Title
inclinometer
Description
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.
Time Frame
for 6 weeks
Title
Modified Somatic Perception Questionnaire
Description
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.
Time Frame
for 6 weeks
Title
algometer
Description
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.
Time Frame
for 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
maria khalid, Ms-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muzaffar Khan Surgical Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
43600
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization in Lumbar Region

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