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.
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
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.
- Conditions
- Trigger Point Pain, Myofascial
- 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 group | Role | What they receive |
|---|---|---|
| myofascial release technique | Experimental | 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 Receives: Other: Myofascial Release Technique; Other: Instrument Assisted Soft tissue Mobilization |
| Instrument Assisted Soft Tissue Mobilization | Experimental | 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. 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.
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
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
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
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
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.
- First posted15 Dec 2021
- Study start15 Feb 2021
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger Point Pain, MyofascialStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria khalid, Ms-OMPT, Principal investigator, Riphah International University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Based Comparison of Myofascial Release Technique and Instrument Assisted Soft Tissue Mobilization on Trigger Points in Lumbar Region
- ClinicalTrials.gov ID
- NCT05158556
- Acronym / sponsor ID
- REC-00936 Irum Nosheen
- Conditions
- Trigger Point Pain, Myofascial
- Keywords
- trigger point,, myofascial release, instrument assisted soft tissue mobilization, range of motion, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 15 Dec 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myofascial release technique | Experimental | Other: Myofascial Release Technique, Other: Instrument Assisted Soft tissue MobilizationMyofascial 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 | Experimental | Other: Myofascial Release Technique, Other: Instrument Assisted Soft tissue Mobilizationinstrument 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- History of spinal surgeries
- Trauma
- Acute Fractures
- Tuberculosis spine
- Wounds, Infections or any other cause of back pain.
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 |
|---|---|---|
| Myofascial Release TechniqueMyofascial Release Technique will be applied with forearm/ ulnar border of palm. Deep pressure will be applied and glided medially towards the thoraco-lumbar region. | Other | Instrument Assisted Soft Tissue Mobilization, myofascial release technique |
| Instrument Assisted Soft tissue Mobilizationinstrument 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. | Other | Instrument Assisted Soft Tissue Mobilization, myofascial release technique |
Primary outcome
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.
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.
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.
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.
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.
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 10 Mar 2022.
- 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.
maria khalid, Ms-OMPT principal investigator
Riphah International 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 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.