High-intensity Laser Therapy and Mulligan Mobilization for Patients With Chronic Nonspecific Low Back Pain

April 22, 2026 updated by: Anas Radi Hassan Alashram

Effects of Combined High-intensity Laser Therapy and Mulligan Mobilization on Patients With Chronic Nonspecific Low Back Pain: A Pilot Randomized Controlled Trial

The goal of this clinical trial is to evaluate whether combining high-intensity laser therapy with Mulligan mobilization techniques can effectively treat chronic non-specific low back pain in adult patients aged 18-60 years, including both males and females.

The main questions it aims to answer are:

Does the combined intervention reduce pain intensity more effectively than standard or single-modality treatment? Does the combined intervention improve functional disability and lumbar range of motion?

Researchers will compare high-intensity laser therapy combined with Mulligan mobilization to [control group: Mulligan alone] to determine whether the combined approach produces superior clinical outcomes.

Participants will:

Receive high-intensity laser therapy according to a standardized treatment protocol Undergo Mulligan mobilization techniques administered by a trained therapist Attend multiple treatment sessions over a defined intervention period Complete assessments of pain intensity, functional disability, and lumbar range of motion before and after treatment

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic non-specific low back pain is a prevalent musculoskeletal condition associated with pain, reduced functional capacity, and decreased quality of life. Conservative management often includes manual therapy and physical modalities; however, the optimal combination of these approaches remains unclear.

High-intensity laser therapy (HILT) has been proposed to provide analgesic and anti-inflammatory effects and to promote tissue healing. Mulligan mobilization techniques, particularly sustained natural apophyseal glides (SNAGs), are commonly used to restore pain-free movement and improve spinal function. While both interventions have shown individual benefits, evidence regarding their combined effect is limited.

This pilot randomized controlled trial aims to explore the feasibility and preliminary clinical effectiveness of combining HILT with Mulligan mobilization in adults with chronic non-specific low back pain. The study will evaluate changes in pain intensity, functional disability, and lumbar range of motion following the intervention period.

Participants will be randomly allocated to intervention groups, and outcomes will be assessed at baseline and post-intervention using standardized clinical measures. Findings from this pilot study will help inform the design of larger trials and clarify whether a multimodal approach incorporating HILT and Mulligan techniques offers added clinical value in this population.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and female participants aged 18-60 years
  • Diagnosis of chronic non-specific low back pain (pain persisting for ≥3 months)
  • Pain localized between the lower costal margins and gluteal folds, with or without referred pain
  • Baseline pain intensity of ≥3 on the Numeric Pain Rating Scale (NPRS)
  • Ability to understand and follow instructions and provide informed consent
  • Not currently receiving other forms of physiotherapy or structured treatment for low back pain during the study period

Exclusion Criteria:

  • Specific spinal pathology (e.g., fracture, tumor, infection, inflammatory diseases such as ankylosing spondylitis)
  • History of spinal surgery
  • Neurological deficits or signs of nerve root compression (e.g., severe radiculopathy)
  • Pregnancy
  • Severe osteoporosis or other contraindications to manual therapy
  • Contraindications to high-intensity laser therapy (e.g., malignancy in the treatment area, photosensitivity disorders)
  • Current use of medications that significantly affect pain perception (e.g., high-dose opioids)
  • Participation in another clinical trial within the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mulligan Mobilization
Mulligan Mobilization alone
Other: Mulligan Mobilization
Mulligan Mobilization alone
Experimental: High-intensity laser therapy and Mulligan mobilization
Combined high-intensity laser therapy and Mulligan mobilization
Device: High-intensity laser therapy and Mulligan mobilization
Combined high-intensity laser therapy and Mulligan mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Change from baseline NPRS at 4-week

The Numeric Pain Rating Scale (NPRS) is a self-reported measure used to assess pain intensity. It typically consists of an 11-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst imaginable pain." Participants are asked to select the number that best reflects their current level of pain, or their average pain over a specified period.

The NPRS is widely used in clinical and research settings due to its simplicity, reliability, and validity in measuring pain intensity in individuals with musculoskeletal conditions, including chronic low back pain. Changes in NPRS scores over time are used to evaluate the effectiveness of therapeutic interventions, with a reduction of approximately 2 points often considered clinically meaningful.
Change from baseline NPRS at 4-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Change from baseline ODI at 4-week

The Oswestry Disability Index (ODI) is a validated self-reported questionnaire used to assess functional disability related to low back pain. It consists of 10 sections evaluating different aspects of daily living, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking.

Each section is scored on a 6-point scale (0-5), with higher scores indicating greater disability. The total score is calculated by summing the section scores and converting them into a percentage, where 0% represents no disability and 100% represents maximum disability.

The ODI is widely used in both clinical practice and research due to its reliability, validity, and sensitivity to change in patients with low back pain. It is commonly used to monitor patient progress and evaluate the effectiveness of interventions over time.
Change from baseline ODI at 4-week
Lumbar Flexion Range of Motion (ROM)
Time Frame: Change from baseline Lumbar Flexion Range of Motion (ROM) at 4-week

Lumbar Flexion Range of Motion (ROM) refers to the degree of forward bending movement of the lumbar spine. It is commonly measured in degrees using instruments such as a goniometer, inclinometer, or dual inclinometer technique.

During assessment, the participant is typically asked to bend forward as far as possible from a standing position while keeping the knees straight. The angle of movement is then recorded in degrees, reflecting the flexibility and mobility of the lumbar spine.

Lumbar flexion ROM is an important clinical outcome in patients with low back pain, as reduced flexion is often associated with pain, stiffness, and functional limitations. Improvements in lumbar flexion degree following intervention indicate enhanced spinal mobility and functional capacity.
Change from baseline Lumbar Flexion Range of Motion (ROM) at 4-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anas Radi Hassan Alashram

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 19, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAD/1199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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