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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06240845
Other study ID # REC/RCR&AHS/23/0239
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date October 10, 2023

Study information

Verified date January 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date October 10, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Pakistan Faiq Medical Complex Faisalabad Punjab
Pakistan Independent University Hospital Faisalabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Level Visual Analogue scale 6 weeks
Primary Rang of motion Straight Leg Raise 6 weeks
Primary Level of Disability Oswestry Disability Index (ODI) 6 weeks
Primary To measure Quality of Life Health Questionnaire (EQ-5D-5L) 6 weeks
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