NCT07556926

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 19, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

April 19, 2026

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    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 Outcomes (2)

  • Oswestry Disability Index (ODI)

    Change from baseline ODI at 4-week

  • Lumbar Flexion Range of Motion (ROM)

    Change from baseline Lumbar Flexion Range of Motion (ROM) at 4-week

Study Arms (2)

Mulligan Mobilization

ACTIVE COMPARATOR

Mulligan Mobilization alone

Other: Mulligan Mobilization

High-intensity laser therapy and Mulligan mobilization

EXPERIMENTAL

Combined high-intensity laser therapy and Mulligan mobilization

Device: High-intensity laser therapy and Mulligan mobilization

Interventions

Combined high-intensity laser therapy and Mulligan mobilization

High-intensity laser therapy and Mulligan mobilization

Mulligan Mobilization alone

Mulligan Mobilization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middle East University

Amman, Jordan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anas Radi Alashram, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2026

First Posted

April 29, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations