Low Level LASER Therapy With and Without Proprioceptive Stimulation Among Discogenic Lumbar Radiculopathy Patients

NCT ID: NCT05953727

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to evaluate the effects of low level laser therapy with and without proprioceptive stimulation on somatosensation, pain and gait parameters in patients with discogenic lumbar radiculopathy. The randomized central trial will recruit patients according to convenience sampling into two intervention groups randomly. One group will receive low level laser therapy and proprioceptive stimulation and other group will receive low level laser therapy alone. Heating packs will be given to both groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Lumbar disc prolapse occurs when disc material, that is, nucleus pulposus or annulus fibrosis comes out of the intervertebral disc space. The ruptured nucleus interacts with the nearby surrounding nerves, resulting in their compression that in turn causes severe radicular pain. Lumbar disc prolapse is considered as a hallmark of low back pain (LBP). Typically, the pain is distributed bilaterally at the posterior beltline with a sharp, shooting pain running down to the low back, buttocks, and down the thigh along with numbness or tingling sensations. One of the major risk factors for low back pain is lumbar disc prolapse. The prevalence of disc prolapse in lumbar region is 90% (L4-L5 or L5-S1). Low back pain due to disc prolapse is generally self-limiting and of shorter duration

A double blind randomized controlled trial was conducted in 2022 by Ishaq et al. on 110 patients to determine the effectiveness of Low-Level Laser Therapy in Patients with Discogenic Lumbar Radiculopathy and correlation among pain intensity, functional disability, and lumbar range of motion (LROM). The outcomes of the treatment were measured on the first day and then after 18 sessions from each patient's pain intensity, functional disability, L-ROM, and straight leg raise by using visual analogue scale, Oswestry disability index, dual inclinometer, and straight leg raise tests. Experimental group of 55 patients was treated with LLLT and conventional physical therapy while the control group of 55 patients was treated with conventional physical therapy alone. They concluded that LLLT is an efficient adjunct therapy to conventional physical therapy in patients of discogenic lumbar radiculopathy

In the reviewed literature, there seems to be a lack in establishing the effects of low-level laser therapy when combined with proprioceptive stimulation. Discogenic lumbar radiculopathy is very common due to an increased workload, increased number of road traffic accidents, poor postures and socioeconomic status, deficient medical or rehab services, and so on. Thus, there is need to conduct a research to determine the effects of low level laser therapy when combined with proprioceptive stimulation in improving patient's functional status, pain and gait issues.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Radiculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Low level laser therapy with proprioceptive stimulation

Patients will be treated with low level laser therapy and proprioceptive stimulation will also be given.

Group Type EXPERIMENTAL

Low level laser therapy with proprioceptive stimulation

Intervention Type OTHER

10 minutes of low level laser therapy and 10-15 minutes of proprioceptive stimulation and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.

Low level laser therapy without proprioceptive stimulation

Patients will be treated with low level laser therapy only.

Group Type ACTIVE_COMPARATOR

Low level laser therapy without proprioceptive stimulation

Intervention Type OTHER

10 minutes of low level laser therapy and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low level laser therapy with proprioceptive stimulation

10 minutes of low level laser therapy and 10-15 minutes of proprioceptive stimulation and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.

Intervention Type OTHER

Low level laser therapy without proprioceptive stimulation

10 minutes of low level laser therapy and 10 minutes of heating pack. Assessment and data collection will be done at baseline (initial), after 4 weeks of treatment protocol and patients will be followed up for the further 2 weeks to notice and report any change in condition and health status.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Heating packs Heating packs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 45-70years(27)
* Both male and female patients
* Patients with acute Low Back Pain and unilateral Discogenic Lumbar Radiculopathy with disc bulge confirmed on MRI
* Pain intensity score is 4 or more on the numeric pain rating scale (NPRS)
* Radiating leg pain symptoms for less than 4 weeks
* Numbness and paresthesia in the affected area
* Patients with moderate to severe score (21%-60%) in ODI

Exclusion Criteria

* Non willing patients
* Patients with severely cognitive disorders
* History of low back pain for more than 4 weeks
* History of any systemic disease such as Stroke, Multiple Sclerosis, Myopathies, Heart Failure etc
* Botulinum toxin injections to any lower extremity muscle in the last 3 months
* Malignancy
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hira Jabeen

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Agile Rehabilitation Complex

Bahawalpur, Punjab Province, Pakistan

Site Status RECRUITING

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hira Jabeen

Role: CONTACT

03234116506

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Muhammad Hafeez

Role: primary

03212319576

Muhammad Irshad

Role: primary

03336352593

References

Explore related publications, articles, or registry entries linked to this study.

Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.

Reference Type BACKGROUND
PMID: 24239490 (View on PubMed)

Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.

Reference Type BACKGROUND
PMID: 24768732 (View on PubMed)

Parker SL, Xu R, McGirt MJ, Witham TF, Long DM, Bydon A. Long-term back pain after a single-level discectomy for radiculopathy: incidence and health care cost analysis. J Neurosurg Spine. 2010 Feb;12(2):178-82. doi: 10.3171/2009.9.SPINE09410.

Reference Type BACKGROUND
PMID: 20121353 (View on PubMed)

Freburger JK, Holmes GM, Agans RP, Jackman AM, Darter JD, Wallace AS, Castel LD, Kalsbeek WD, Carey TS. The rising prevalence of chronic low back pain. Arch Intern Med. 2009 Feb 9;169(3):251-8. doi: 10.1001/archinternmed.2008.543.

Reference Type BACKGROUND
PMID: 19204216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35265302 (View on PubMed)

Benditz A, Loher M, Boluki D, Grifka J, Vollner F, Renkawitz T, Maderbacher G, Gotz J. Positive medium-term influence of multimodal pain management on socioeconomic factors and health care utilization in patients with lumbar radiculopathy: a prospective study. J Pain Res. 2017 Feb 14;10:389-395. doi: 10.2147/JPR.S128090. eCollection 2017.

Reference Type BACKGROUND
PMID: 28243143 (View on PubMed)

National Guideline Centre (UK). Low Back Pain and Sciatica in Over 16s: Assessment and Management. London: National Institute for Health and Care Excellence (NICE); 2016 Nov. Available from http://www.ncbi.nlm.nih.gov/books/NBK401577/

Reference Type BACKGROUND
PMID: 27929617 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR & AHS/23/0220

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.