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

NCT05953727 | Unknown

• 1 other identifier: REC/RCR & AHS/23/0220
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lumbar Radiculopathy

Keywords

Discogenic Lumbar Radiculopathy; Gait Parameters; Low-Level Laser Therapy; Numeric pain rating scale

Outcome Measures

Primary Outcomes (5)

• Nottingham Sensory Assessment

  Multimodal sensory examination includes test of tactile sensation, kinesthesia and stereognosis.

  6 weeks

• NPRS

  It is a common pain screening tool use to assess the severity of pain at moment time. It is '0-10' scale where '0' means 'no pain' and '10' means 'worst pain imaginable'.

  6 weeks

• Step length

  The distance measured in centimeters between the point of initial contact of one foot and the point of initial contact of the opposite foot is referred to as the step length.

  6 weeks

• Stride Length

  The distance covered in centimeters with two consecutive steps, one with each foot.

  6 weeks

• Walking Cadence

  Number of steps taken by an individual in one minute

  6 weeks

Secondary Outcomes (1)

• 6 Minute Walk Test (6MWT)

  6 weeks

Study Arms (2)

Low level laser therapy with proprioceptive stimulation

EXPERIMENTAL

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

Other: Low level laser therapy with proprioceptive stimulation

Low level laser therapy without proprioceptive stimulation

ACTIVE COMPARATOR

Patients will be treated with low level laser therapy only.

Other: Low level laser therapy without proprioceptive stimulation

Interventions

Low level laser therapy with proprioceptive stimulation 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.

Also known as: Heating packs

Low level laser therapy with proprioceptive stimulation

Low level laser therapy without proprioceptive stimulation 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.

Also known as: Heating packs

Low level laser therapy without proprioceptive stimulation

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (2)

Agile Rehabilitation Complex

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

Bahawal Victoria Hospital

Bahawalpur, Punjab Province, 63100, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 24239490 BACKGROUND

• 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.

  PMID: 24768732 BACKGROUND

• 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.

  PMID: 20121353 BACKGROUND

• 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.

  PMID: 19204216 BACKGROUND

• 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: 35265302 BACKGROUND

• 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.

  PMID: 28243143 BACKGROUND

• 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/

  PMID: 27929617 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Hira Jabeen

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Jabeen

CONTACT

03234116506; hira.jabeen@riphah.edu.pk

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: June 26, 2023
• First Posted: July 20, 2023
• Study Start: November 11, 2022
• Primary Completion: August 15, 2023
• Study Completion: October 1, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)