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Trigger Point Pain, MyofascialNCT05158556

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

A study testing Myofascial Release Technique and Instrument Assisted Soft tissue Mobilization in people with Trigger Point Pain, Myofascial, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 55 years
Conditions the study is for
Trigger Point Pain, Myofascial
What is being tested?
Myofascial Release Technique and Instrument Assisted Soft tissue Mobilization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 sitePakistan
Study dates
15 Feb 2021to 20 Jan 2022
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 30 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • History of spinal surgeries
  • Trauma
  • Acute Fractures
  • Tuberculosis spine
  • Wounds, Infections or any other cause of back pain.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Muzaffar Khan Surgical Hospital

    Rawalpindi, Punjab Province, 43600

Other trials in Pakistan

About this study

Official title: Gender Based Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization on Trigger Points in Lumbar Region

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.

Read the 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.

Being tested
Myofascial Release Technique, Instrument Assisted Soft tissue Mobilization
Keywords
trigger point,, myofascial release, instrument assisted soft tissue mobilization, range of motion, pain
Medical subject headings
Myofascial Pain Syndromes, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Myofascial Release TechniqueOther

    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 MobilizationOther

    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.

Study groups in NCT05158556
Study groupRoleWhat they receive
myofascial release techniqueExperimentalMyofascial 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
Receives: Other: Myofascial Release Technique; Other: Instrument Assisted Soft tissue Mobilization
Instrument Assisted Soft Tissue MobilizationExperimentalinstrument 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.
Receives: Other: Myofascial Release Technique; Other: Instrument Assisted Soft tissue Mobilization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: for 6 weeks

  2. 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.

    Measured: for 6 weeks

  3. 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.

    Measured: for 6 weeks

  4. 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.

    Measured: for 6 weeks

  5. 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.

    Measured: for 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2021
  2. Study start15 Feb 2021
  3. Primary completion20 Jan 2022
  4. Study completion20 Jan 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05158556
Sponsor's protocol ID
REC-00936 Irum Nosheen
Status last verified
Mar 2022
First submitted
13 Dec 2021
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Myofascial Release Technique and Instrument Assisted Soft tissue Mobilization in people with Trigger Point Pain, Myofascial, run by Riphah International University at 1 site in Pakistan.

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 3 inclusion and 5 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 10 Mar 2022. 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 Pakistan. 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?

Numeric Pain Rating Scale (time frame: for 6 weeks). The study lists 5 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 10 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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