NCT06240845

Brief Summary

To Compare the effects of high-level laser therapy (HLLT) and low-level laser therapy (LLLT) on pain in patients with lumbar radiculopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

January 28, 2024

Last Update Submit

January 28, 2024

Conditions

Keywords

HLLT, Laser therapy , LLLT, Lumber radiculopathy, Sciatica

Outcome Measures

Primary Outcomes (4)

  • Pain Level

    Visual Analogue scale

    6 weeks

  • Rang of motion

    Straight Leg Raise

    6 weeks

  • Level of Disability

    Oswestry Disability Index (ODI)

    6 weeks

  • To measure Quality of Life

    Health Questionnaire (EQ-5D-5L)

    6 weeks

Study Arms (2)

High Level Laser Therapy

EXPERIMENTAL

This group received High-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.

Other: High-level laser therapy

Low Level Laser Therapy

EXPERIMENTAL

This group received Low-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.

Other: Low-level laser therapy

Interventions

This group received High-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.

High Level Laser Therapy

This group received Low-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.

Low Level Laser Therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both genders male and female will be included.
  • Patients aged 40-65 years will be included.
  • Patients with a diagnosis of lumbar radiculopathy confirmed by clinical evaluation by a physician or physiotherapist.
  • Patients with a history of radicular leg pain and/or numbness or tingling sensation in the leg.
  • a positive score on the Straight Leg Raise (pain between 35 degrees and 75 degrees), pain limiting functional ability, and scores at least 3/10 on the VAS, restricted lumbar range of motion - 25% flexion, 20% extension.
  • Patients who have not received any form of treatment for lumbar radiculopathy within the past 3 months

You may not qualify if:

  • Patients with a history of spinal surgery in the last 2 years or spinal deformity.
  • Patients with a history of fracture or dislocation of the lumbar spine.
  • Patients with a diagnosis of any other neurological disorder or neuropathy.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other medical condition that may interfere i.e. inflammatory rheumatic disease, cardiac pacemaker, continuing that may interfere with the study outcomes or put them at risk with the study outcomes or put them at risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faiq Medical Complex

Faisalābad, Punjab Province, 54000, Pakistan

Location

Independent University Hospital

Faisalābad, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • Kolu E, Buyukavci R, Akturk S, Eren F, Ersoy Y. Comparison of high-intensity laser therapy and combination of transcutaneous nerve stimulation and ultrasound treatment in patients with chronic lumbar radiculopathy: A randomized single-blind study. Pak J Med Sci. 2018 May-Jun;34(3):530-534. doi: 10.12669/pjms.343.14345.

    PMID: 30034410BACKGROUND
  • Ince S, Eyvaz N, Dundar U, Toktas H, Yesil H, Eroglu S, Adar S. Clinical Efficiency of High-Intensity Laser Therapy in Patients With Cervical Radiculopathy: A 12-Week Follow-up, Randomized, Placebo-Controlled Trial. Am J Phys Med Rehabil. 2024 Jan 1;103(1):3-12. doi: 10.1097/PHM.0000000000002275. Epub 2023 May 1.

    PMID: 37204965BACKGROUND
  • Konstantinovic LM, Cutovic MR, Milovanovic AN, Jovic SJ, Dragin AS, Letic MDj, Miler VM. Low-level laser therapy for acute neck pain with radiculopathy: a double-blind placebo-controlled randomized study. Pain Med. 2010 Aug;11(8):1169-78. doi: 10.1111/j.1526-4637.2010.00907.x.

    PMID: 20704667BACKGROUND
  • Ahmed I, Bandpei MAM, Gilani SA, Ahmad A, Zaidi F. Effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy: A Double-Blind Randomized Controlled Trial. J Healthc Eng. 2022 Feb 27;2022:6437523. doi: 10.1155/2022/6437523. eCollection 2022.

    PMID: 35265302BACKGROUND
  • Ahmed I, Mohseni Bandpei MA, Gilani SA, Ahmad A, Zaidi F. Correlation Analysis Between Pain Intensity, Functional Disability and Range of Motion Using Low-Level Laser Therapy in Patients With Discogenic Lumbar Radiculopathy: A Cross-sectional Study. J Lasers Med Sci. 2022 Jun 6;13:e26. doi: 10.34172/jlms.2022.26. eCollection 2022.

    PMID: 36743144BACKGROUND
  • Danazumi MS, Bello B, Yakasai AM, Kaka B. Two manual therapy techniques for management of lumbar radiculopathy: a randomized clinical trial. J Osteopath Med. 2021 Feb 26;121(4):391-400. doi: 10.1515/jom-2020-0261.

    PMID: 33705612BACKGROUND
  • Rogerson A, Aidlen J, Jenis LG. Persistent radiculopathy after surgical treatment for lumbar disc herniation: causes and treatment options. Int Orthop. 2019 Apr;43(4):969-973. doi: 10.1007/s00264-018-4246-7. Epub 2018 Nov 29.

    PMID: 30498910BACKGROUND
  • Kostadinovic S, Milovanovic N, Jovanovic J, Tomasevic-Todorovic S. Efficacy of the lumbar stabilization and thoracic mobilization exercise program on pain intensity and functional disability reduction in chronic low back pain patients with lumbar radiculopathy: A randomized controlled trial. J Back Musculoskelet Rehabil. 2020;33(6):897-907. doi: 10.3233/BMR-201843.

    PMID: 32675390BACKGROUND
  • Ghasabmahaleh SH, Rezasoltani Z, Dadarkhah A, Hamidipanah S, Mofrad RK, Najafi S. Spinal Manipulation for Subacute and Chronic Lumbar Radiculopathy: A Randomized Controlled Trial. Am J Med. 2021 Jan;134(1):135-141. doi: 10.1016/j.amjmed.2020.08.005. Epub 2020 Sep 13.

    PMID: 32931763BACKGROUND

MeSH Terms

Conditions

RadiculopathySciatica

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSciatic NeuropathyMononeuropathiesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

August 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 10, 2023

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations