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

NCT07593586 | Completed DMC

• 1 other identifier: GIU/REC/26-31
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Myofascial Pain Syndrome - Lower Back

Keywords

Lumbar myofascial pain syndrome; McKenzie extension protocol; Graston technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Range of motion by universal goniometer

  Baseline, 6th week and 12th week post intervention

• Functional disability by modified oswestry disability index

  Baseline, 6th week and 12th week post intervention

Study Arms (2)

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.

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.

Procedure: Mckenzie Extension Protocol without Graston technique

Interventions

Mckenzie Extension Protocol with Graston technique PROCEDURE

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 with Graston technique

Mckenzie Extension Protocol without Graston technique PROCEDURE

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.

Mckenzie Extension Protocol without Graston technique

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Green International University: lead

Study Sites (1)

Johar pain relief center

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI 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

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: April 28, 2025
• Primary Completion: April 29, 2026
• Study Completion: May 4, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It will be available after the completion of the study.
• 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.

Locations

PA (1)