Clinical trial NCT06240845: Effect of High Versus Low-level Laser Therapy in Patients of Lumber Radiculopathy
Official title: Effect of High Versus Low-level Laser Therapy in Patients of Lumber Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: HLLT, Laser therapy , LLLT, Lumber radiculopathy, Sciatica
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain Level
timeFrame: 6 weeks
measure: Rang of motion
timeFrame: 6 weeks
measure: Level of Disability
timeFrame: 6 weeks
measure: To measure Quality of Life
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Faiq Medical Complex
state: Punjab
city: Faisalābad
country: Pakistan
facility: Independent University Hospital
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.