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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome - Lower Back
• Intervention / Treatment: Procedure: Mckenzie Extension Protocol with Graston technique; Procedure: Mckenzie Extension Protocol without Graston technique

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Johar pain relief center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
  • Previous back surgery
  • Severe osteoporosis
  • Spinal instability
  • Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mckenzie Extension Protocol with Graston technique; 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.	Procedure: Mckenzie Extension Protocol with Graston technique; 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6th week and 12th week post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Baseline, 6th week and 12th week post intervention

Collaborators and Investigators

• Sponsor: Green International University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Actual): April 29, 2026
• Study Completion (Actual): May 4, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Graston technique; Lumbar myofascial pain syndrome; McKenzie extension protocol
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: GIU/REC/26-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the results publication will be shared.
• IPD Sharing Time Frame: It will be available after the completion of the study.
• IPD Sharing Access Criteria: Data requests should be sent to the corresponding author. Access will be granted to qualified researchers for approved research proposals. Data will be de-identified before sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No