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Low-Level Laser and Exercise Therapy for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Hammad Qazi, PhD

Research Sponsored by Health Rehab and Research Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals aged 18-65 with the ability to give informed consent

Report non-specific chronic low back pain of >3 months duration in the lumbosacral area of the spine, not attributable to a recognizable, known pathology, and with pain measured using the Quadruple Visual Analogue Scale between 4 and 7 at the time of assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1, 2, 3, 6, 8, 12, 26 and 52

Awards & highlights

Study Summary

This trial will study whether low-level laser therapy, when used alongside exercise, can reduce pain and improve function in people with non-specific chronic low back pain.

Who is the study for?

This trial is for adults aged 18-65 with chronic low back pain lasting more than 3 months, who can consent to treatment. They must have moderate pain without a specific known cause. Excluded are those with neurological disorders, spine fractures or surgeries, pregnancy, cardiovascular diseases, phototherapy allergy, certain medication use, infections, pacemaker users, skin conditions in the treatment area or drug abuse history.Check my eligibility

What is being tested?

The study tests if Low-Level Laser Therapy (LLLT) alongside standard exercises helps reduce chronic lower back pain better than exercise alone. Participants will be randomly assigned to receive either LLLT plus exercise or just exercise and won't know which group they're in (double-blind).See study design

What are the potential side effects?

Potential side effects of LLLT may include mild skin irritation at the site of application and temporary increase in pain following therapy sessions. Standard exercise therapy typically has minimal side effects but may include muscle soreness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old and can make my own medical decisions.

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I have had lower back pain for over 3 months, with a pain level between 4 and 7.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1, 2, 3, 6, 8, 12, 26 and 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1, 2, 3, 6, 8, 12, 26 and 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1, 2, 3, 6, 8, 12, 26 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Pain using the Brief Pain Inventory

Change in Pain using the McGill Pain Questionnaire

Change in Pain using the Quadruple Visual Analog Scale

Secondary outcome measures

Fear of Pain measured using the McGill Pain Questionnaire

Frequency of Low Back Pain Episodes assessed using patients personal daily pain records

Mean Pain Free Days/Months using the Brief Pain Inventory

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Low Level Laser Therapy + standard exercise therapyExperimental Treatment2 Interventions

This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by the Low Lever Laser Therapy.

Group II: Standard Exercise TherapyActive Control1 Intervention

Trial participants in this group will only receive the standard exercise therapy. The exercise therapy will consist of strengthening and stretching exercises.

Group III: Sham Low Level Laser Therapy + standard exercise therapyPlacebo Group2 Interventions

This group of participants will first receive the standard therapy of strengthening and stretching exercises followed by a sham Low Level Laser Therapy (LLLT). The laser equipment will be deactivated and not switched on.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Health Rehab and Research ClinicLead Sponsor

Hammad Qazi, PhDPrincipal InvestigatorHealth and Rehab Research Inc

Media Library

Standard Exercise Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05040633 — N/A

Chronic Lower Back Pain Research Study Groups: Standard Exercise Therapy, Low Level Laser Therapy + standard exercise therapy, Sham Low Level Laser Therapy + standard exercise therapy

Chronic Lower Back Pain Clinical Trial 2023: Standard Exercise Therapy Highlights & Side Effects. Trial Name: NCT05040633 — N/A

Standard Exercise Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040633 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this research study currently feasible for me?

"This medical trial is attempting to recruit 216 persons, aged 18-65 who are struggling with back pain. In order to be considered for the study, patients must meet further criteria: possess a Quadruple Visual Analogue Scale rating between 4 and 7 at the time of assessment; provide informed consent; report non-specific chronic low back agony that has persisted more than 3 months in their lumbosacral area without any recognized pathologies (e.g., infection, tumor, osteoporosis)."

Answered by AI

Is the criterion for enrollment in this trial restricted to individuals over 35 years of age?

"This clinical trial has an age cap of 65 and a minimum enrollment threshold of 18."

Answered by AI

What outcomes is this research endeavor trying to prove?

"This trial, evaluated over several intervals (Weeks 1, 2, 3, 6, 8, 12, 26 and 52) aspires to curb pain using the McGill Pain Questionnaire. Secondary objectives include calculating Mean Pain Free Days/Months with Brief Pain Inventory from Weeks 6-52; measuring reduction in agony based on a 0-10 scale via the aforementioned questionnaire; assessing reliance on medication for ache management utilizing BPI during Week 6-52; and lastly recording Frequency of Low Back pain Episodes according to patients' daily records at Weeks 1-52."

Answered by AI

Is there still an opportunity to participate in this clinical experimentation?

"The clinicaltrials.gov database reveals that enrollment for this medical trial has been suspended since August 2nd, 2022. Despite its inactivity, there are 333 other active trials currently accepting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The ECEALT Chronic Low Back Pain Study

2022. "The ECEALT Chronic Low Back Pain Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040633.

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