- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06240845
Effect of High Versus Low-level Laser Therapy in Patients of Lumber Radiculopathy
January 28, 2024 updated by: Riphah International University
To Compare the effects of high-level laser therapy (HLLT) and low-level laser therapy (LLLT) on pain in patients with lumbar radiculopathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
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 Locations
-
-
Punjab
-
Faisalābad, Punjab, Pakistan, 54000
- Faiq Medical Complex
-
Faisalābad, Punjab, Pakistan, 54000
- Independent University Hospital
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High Level Laser Therapy
This group received High-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.
|
This group received High-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.
|
|
Experimental: Low Level Laser Therapy
This group received Low-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.
|
This group received Low-level laser therapy along with conventional physiotherapy treatment 3 times per week for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Level
Time Frame: 6 weeks
|
Visual Analogue scale
|
6 weeks
|
|
Rang of motion
Time Frame: 6 weeks
|
Straight Leg Raise
|
6 weeks
|
|
Level of Disability
Time Frame: 6 weeks
|
Oswestry Disability Index (ODI)
|
6 weeks
|
|
To measure Quality of Life
Time Frame: 6 weeks
|
Health Questionnaire (EQ-5D-5L)
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Binash Afzal, PHD*, Riphah International University Lahore Campus
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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 (Actual)
August 1, 2023
Primary Completion (Actual)
September 30, 2023
Study Completion (Actual)
October 10, 2023
Study Registration Dates
First Submitted
January 28, 2024
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Estimated)
February 5, 2024
Study Record Updates
Last Update Posted (Estimated)
February 5, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0239
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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