Myofascial Pain Syndrome - Lower BackNCT07593586
Trials to Determine the Effects of Mckenzie Extension Protocol With and Without Graston Technique on Pain Intensity, Range of Motion and Functional Disability in Patients With Lumbar Myofascial Pain Syndrome
A study testing Mckenzie Extension Protocol with Graston technique and Mckenzie Extension Protocol without Graston technique in people with Myofascial Pain Syndrome - Lower Back, run by Green International University at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to learn if the Mckenzie Extension Protocol with and without Graston technique works to treat Lumbar Myofascial Pain Syndrome.This clinical trial compares the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myofascial Pain Syndrome - Lower Back
- What is being tested?
- Mckenzie Extension Protocol with Graston technique and Mckenzie Extension Protocol without Graston technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2025to 4 May 2026
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-55 years old
- Both gender male or female
- History of chronic low back pain (CLBP) caused by lumbar myofascial pain (LMP), with a duration greater than 6 months
- Myofacial trigger points(MTrPs) located in the corresponding lumbar muscles, such as the quadratus lumborum muscle
- Mechanical stimulation of MTrPs produced intense local and referred pain, differing from pain expected from nerve root compression alone
Who cannot join
- Serious fractures or tumours
- Ankylosing spondylitis
- Nerve root compromise
- Severe or unstable cardiopulmonary diseases
- Cervical or thoracic pain rather than lumbar pain
- Sickle cell disease
Show all 10Show fewer
- Previous back surgery
- Severe osteoporosis
- Spinal instability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mckenzie Extension Protocol With and Without Graston Technique on Pain Intensity, Range of Motion and Functional Disability in Patients With Lumbar Myofascial Pain Syndrome
The goal of this clinical trial is to learn if the Mckenzie Extension Protocol with and without Graston technique works to treat Lumbar Myofascial Pain Syndrome.This clinical trial compares the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome.Adults with Lumbar Myofascial Pain were included in this study. A total of 70 participants were divided into two groups with 35 patients in each group.
One group received Mckenzie Extension Protocol with Graston technique and the other group received Mckenzie Extension Protocol without Graston technique . Pain was assessed using the visual analogue scale and functional disability was measured using modified oswestry disability index . Range of motion was also evaluated before and after treatment by universal goniometer.
Read the detailed description
Lumbar myofascial pain syndrome (LMPS) is one of the most common causes of chronic low back pain, and is a musculoskeletal disorder characterized by localized pain due to trigger points, palpable intramuscular taut bands, and referred pain. The MTrPs are hyperirritable spots, usually within a taut band of muscle fibers or in the muscle fascia, which are painful on compression and can give rise to characteristic referred pain, motor dysfunction, and autonomic phenomena .Conservative management through manual therapy is widely used, but comparative effectiveness of different techniques remains unclear. This randomized clinical trial was designed to compare the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome. A total of 70 participants diagnosed with Lumbar Myofascial Pain Syndrome were recruited . All the screened and willing participants were randomly allocated to two groups by lottery method with 35 patients in each group. (Group A: Experimental group /GT group, Group B: Comparative Group / MEP group) . Group A participants received the Graston technique with the McKenzie extension protocol. The same exercise program will be applied to the patients in both groups, three days a week, for four weeks. The exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance.
The stretching exercise will be prescribed three times a day, for three sets of ten repetitions, with each stretch lasting 15 to 30 seconds. The number of repetitions will be checked weekly and increased gradually according to tolerance.
To treat the affected areas of patients in the intervention group, a Graston instrument will be applied to the superficial and deep fascia of the erector spinae, gluteus maximus, gluteus medius, and hamstrings by the physiotherapist. Initially, patients will be asked to kneel directly on the bed and lean forward. In this position, the superficial and deep fascia of the erector spinae will be treated. The Graston technique will then be applied to the gluteus maximus and gluteus medius in the hip and knee flexion position, with the patient in a side-lying position, and will be performed in the prone position for the hamstring muscles.
The largest Graston instrument (GT1), designed to treat soft tissue restrictions over large surface areas, will be used. A lubricating cream will be applied to facilitate smooth gliding of the instrument over the tissues. The Graston technique will be applied for 20 seconds at a 45° angle parallel to the muscle fibers for each treated muscle, followed by an additional 20 seconds at a 45° angle perpendicular to the muscle fibers. The total treatment time will be approximately 40 seconds per muscle.
Patients will be informed that they may experience pain, bruising, or small red spots (petechiae) in the treated area. If severe pain occurs after treatment, ice will be applied for 15-20 minutes. The Graston technique will be administered three times a week for four weeks.
Group B received Mckenzie Extension Protocol without Graston technique . The McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement. Outcome measures were assessed at baseline and post-intervention.
Pain was assessed using the visual analogue scale and functional disability was measured using modified Oswestry disability index. Range of motion was also evaluated before and after treatment by universal goniometer. The primary objective of this study is To determine the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome. The findings will help clinicians select the most effective manual therapy approach for managing Lumbar Myofascial Pain Syndrome.
- Conditions
- Myofascial Pain Syndrome - Lower Back
- Being tested
- Mckenzie Extension Protocol with Graston technique, Mckenzie Extension Protocol without Graston technique
- Keywords
- Lumbar myofascial pain syndrome, McKenzie extension protocol, Graston technique
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie Extension Protocol with Graston techniqueProcedure or surgery
The exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance.
The stretching exercise will be prescribed three times a day, for three sets of ten repetitions, with each stretch lasting 15 to 30 seconds. The number of repetitions will be checked weekly and increased gradually according to tolerance.
To treat the affected areas of patients in the intervention group, a Graston instrument will be applied to the superficial and deep fascia of the erector spinae, gluteus maximus, gluteus medius, and hamstrings by the physiotherapist. Initially, patients will be asked to kneel directly on the bed and lean forward. In this position, the superficial and deep fascia of the erector spinae will be treated.
Mckenzie Extension Protocol without Graston techniqueProcedure or surgery
The McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement.
| Study group | Role | What they receive |
|---|---|---|
| Mckenzie Extension Protocol with Graston technique | Experimental | Group A participants received the Graston technique with the McKenzie extension protocol. The same exercise program will be applied to the patients in both groups, three days a week, for four weeks. The exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance. The Graston technique will then be applied to the gluteus maximus and gluteus medius in the hip and knee flexion position, with the patient in a side-lying position, and will be performed in the prone position for the hamstring muscles. Receives: Procedure: Mckenzie Extension Protocol with Graston technique |
| Mckenzie Extension Protocol without Graston technique | Active comparator | The McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement. Receives: Procedure: Mckenzie Extension Protocol without Graston technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain by visual analogue scale
The Visual Analog Scale (VAS) is a 100 mm line used to measure pain intensity, with endpoints representing the worst and best possible pain, allowing tracking of changes over time or comparison between patients.
Measured: Baseline, 6th week and 12th week post intervention
Secondary outcomes (2)
Range of motion by universal goniometer
Lumbar range of motion (ROM) will be measured using a standard goniometer to assess flexion, extension, and lateral bending. In healthy adults, normal lumbar flexion ranges from 40°-60°, extension from 20°-35°, and lateral bending from 15°-20° on each side. Participants will perform maximum trunk movements while standing comfortably, with the goniometer's axis placed at the L3 level, one arm aligned with the pelvis and the other with the thoracic spine. Each movement will be measured three times, and the average value will be used for analysis. Hip flexion, which normally ranges from 110°-120°, will be assessed in the supine position, with the axis at the greater trochanter, the stationary arm along the trunk, and the movable arm along the femur, recording the mean of three readings for accuracy and reliability.
Measured: Baseline, 6th week and 12th week post intervention
Functional disability by modified oswestry disability index
One popular self-report tool for gauging the extent to which low back pain impairs a person's functional capacity and quality of life is the Modified Oswestry Disability Index (ODI). On a scale from 0 to 5 or 6, the respondent scores their level of disability for each of the ten parts that cover different everyday tasks. A higher percentage indicates a greater degree of disability, as the results are combined and expressed as a whole
Measured: Baseline, 6th week and 12th week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start28 Apr 2025
- Primary completion29 Apr 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - Lower BackStudies of the same condition, open and under way.
- 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
- Model description
- This is a randomized, parallel-group interventional study. Participants with Lumbar Myofascial Pain Syndrome were randomly assigned in a 1:1 ratio to one of two treatment arms. Group A received Mckenzie Extension Protocol with Graston technique and the group B received Mckenzie Extension Protocol without Graston technique. Both interventions were administered for the specifiec treatment period to compare their effectiveness on pain reduction and improvement in lumbar range of motion and functional disability.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa Nazir Khan, Green International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593586
- Sponsor's protocol ID
- GIU/REC/26-31
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mckenzie Extension Protocol With and Without Graston Technique on Pain Intensity, Range of Motion and Functional Disability in Patients With Lumbar Myofascial Pain Syndrome
- ClinicalTrials.gov ID
- NCT07593586
- Acronym / sponsor ID
- GIU/REC/26-31
- Conditions
- Myofascial Pain Syndrome - Lower Back
- Keywords
- Lumbar myofascial pain syndrome, McKenzie extension protocol, Graston technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Green International UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 18 May 2026 (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 goal of this clinical trial is to learn if the Mckenzie Extension Protocol with and without Graston technique works to treat Lumbar Myofascial Pain Syndrome.This clinical trial compares the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome.Adults with Lumbar Myofascial Pain were included in this study. A total of 70 participants were divided into two groups with 35 patients in each group.
One group received Mckenzie Extension Protocol with Graston technique and the other group received Mckenzie Extension Protocol without Graston technique . Pain was assessed using the visual analogue scale and functional disability was measured using modified oswestry disability index . Range of motion was also evaluated before and after treatment by universal goniometer.
Detailed description
Lumbar myofascial pain syndrome (LMPS) is one of the most common causes of chronic low back pain, and is a musculoskeletal disorder characterized by localized pain due to trigger points, palpable intramuscular taut bands, and referred pain. The MTrPs are hyperirritable spots, usually within a taut band of muscle fibers or in the muscle fascia, which are painful on compression and can give rise to characteristic referred pain, motor dysfunction, and autonomic phenomena .Conservative management through manual therapy is widely used, but comparative effectiveness of different techniques remains unclear. This randomized clinical trial was designed to compare the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome. A total of 70 participants diagnosed with Lumbar Myofascial Pain Syndrome were recruited . All the screened and willing participants were randomly allocated to two groups by lottery method with 35 patients in each group. (Group A: Experimental group /GT group, Group B: Comparative Group / MEP group) . Group A participants received the Graston technique with the McKenzie extension protocol. The same exercise program will be applied to the patients in both groups, three days a week, for four weeks. The exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance.
The stretching exercise will be prescribed three times a day, for three sets of ten repetitions, with each stretch lasting 15 to 30 seconds. The number of repetitions will be checked weekly and increased gradually according to tolerance.
To treat the affected areas of patients in the intervention group, a Graston instrument will be applied to the superficial and deep fascia of the erector spinae, gluteus maximus, gluteus medius, and hamstrings by the physiotherapist. Initially, patients will be asked to kneel directly on the bed and lean forward. In this position, the superficial and deep fascia of the erector spinae will be treated. The Graston technique will then be applied to the gluteus maximus and gluteus medius in the hip and knee flexion position, with the patient in a side-lying position, and will be performed in the prone position for the hamstring muscles.
The largest Graston instrument (GT1), designed to treat soft tissue restrictions over large surface areas, will be used. A lubricating cream will be applied to facilitate smooth gliding of the instrument over the tissues. The Graston technique will be applied for 20 seconds at a 45° angle parallel to the muscle fibers for each treated muscle, followed by an additional 20 seconds at a 45° angle perpendicular to the muscle fibers. The total treatment time will be approximately 40 seconds per muscle.
Patients will be informed that they may experience pain, bruising, or small red spots (petechiae) in the treated area. If severe pain occurs after treatment, ice will be applied for 15-20 minutes. The Graston technique will be administered three times a week for four weeks.
Group B received Mckenzie Extension Protocol without Graston technique . The McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement. Outcome measures were assessed at baseline and post-intervention.
Pain was assessed using the visual analogue scale and functional disability was measured using modified Oswestry disability index. Range of motion was also evaluated before and after treatment by universal goniometer. The primary objective of this study is To determine the Effects of Mckenzie Extension Protocol with and without Graston technique on Pain intensity, Range of Motion and functional Disability in Patients with Lumbar Myofascial Pain Syndrome. The findings will help clinicians select the most effective manual therapy approach for managing Lumbar Myofascial Pain Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group interventional study. Participants with Lumbar Myofascial Pain Syndrome were randomly assigned in a 1:1 ratio to one of two treatment arms. Group A received Mckenzie Extension Protocol with Graston technique and the group B received Mckenzie Extension Protocol without Graston technique. Both interventions were administered for the specifiec treatment period to compare their effectiveness on pain reduction and improvement in lumbar range of motion and functional disability.
| Arm | Type | Receives |
|---|---|---|
| Mckenzie Extension Protocol with Graston technique | Experimental | Procedure: Mckenzie Extension Protocol with Graston techniqueGroup A participants received the Graston technique with the McKenzie extension protocol. The same exercise program will be applied to the patients in both groups, three days a week, for four weeks. The exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance. The Graston technique will then be applied to the gluteus maximus and gluteus medius in the hip and knee flexion position, with the patient in a side-lying position, and will be performed in the prone position for the hamstring muscles. |
| Mckenzie Extension Protocol without Graston technique | Active comparator | Procedure: Mckenzie Extension Protocol without Graston techniqueThe McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18-55 years old
Key exclusion criteria (10 listed)
- Serious fractures or tumours
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 |
|---|---|---|
| Mckenzie Extension Protocol with Graston techniqueThe exercise program will include exercises for stretching the lower back muscles including knee to chest, double knee to chest, straight leg raises, cat and camel, and quadratus lumborum stretch. The program will be prescribed and supervised by a physiotherapist and will be adapted according to each patient's tolerance. The stretching exercise will be prescribed three times a day, for three sets of ten repetitions, with each stretch lasting 15 to 30 seconds. The number of repetitions will be checked weekly and increased gradually according to tolerance. To treat the affected areas of patients in the intervention group, a Graston instrument will be applied to the superficial and deep fascia of the erector spinae, gluteus maximus, gluteus medius, and hamstrings by the physiotherapist. Initially, patients will be asked to kneel directly on the bed and lean forward. In this position, the superficial and deep fascia of the erector spinae will be treated. | Procedure or surgery | Mckenzie Extension Protocol with Graston technique |
| Mckenzie Extension Protocol without Graston techniqueThe McKenzie exercise approach will focus on addressing posterior derangement, which is a common occurrence in patients with low back pain. The reductive force used in this approach will be extension. The expected response to McKenzie exercises will include centralization of symptoms, reduction or elimination of pain, a possible temporary increase in centralized pain, increased range of motion in extension, and overall reduction of derangement. | Procedure or surgery | Mckenzie Extension Protocol without Graston technique |
Primary outcome
Pain by visual analogue scale
Time frame: Baseline, 6th week and 12th week post intervention
The Visual Analog Scale (VAS) is a 100 mm line used to measure pain intensity, with endpoints representing the worst and best possible pain, allowing tracking of changes over time or comparison between patients.
2 secondary outcomes
Range of motion by universal goniometer
Time frame: Baseline, 6th week and 12th week post intervention
Functional disability by modified oswestry disability index
Time frame: Baseline, 6th week and 12th week post intervention
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 18 May 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie Extension Protocol with Graston technique and Mckenzie Extension Protocol without Graston technique in people with Myofascial Pain Syndrome - Lower Back, run by Green 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 5 inclusion and 10 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 18 May 2026. 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?
Pain by visual analogue scale (time frame: Baseline, 6th week and 12th week post intervention). 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 18 May 2026.