- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06428565
Conventional Exercises Plan With or Without Laser Guided Feedback for Patients With Non-Specific Low Back Pain
May 20, 2024 updated by: Muhammad Naveed Babur, Superior University
Low back pain (LBP) is a significant health issue.
It impacts a significant portion of the adult population, reaching up to 80%, and results in substantial healthcare and socioeconomic expenses.
To find out what changes occurred after the application of two exercise modalities [Conventional Exercise (CE) and Laser-Guided Exercise (LGE)} and PNE on pain, pain pressure thresholds, disability, catastrophizing, kinesiophobia, and lumbar proprioception in subjects with NSCLBP.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan
- Hameed Latif Hospital Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both male and female ages between 18 and 45 years (11).
- Patients diagnosed with nonspecific low back pain (11).
- patients with pain intensity of "3" or greater on numeric pain rating scale
Exclusion Criteria:
- Patients with neurological symptoms.
- Patients diagnosed with fatigue syndrome
- Females having pregnancy
- History of low back surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low-level laser therapy (LLLT) or cold laser therapy
uses low-level lasers or light-emitting diodes to stimulate cellular function and improve healing.
Physiotherapy, sports medicine, and rehabilitation use it as a non-invasive, painless complement or adjuvant therapy
|
Low-level laser therapy (LLLT) or cold laser therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Numeric Pain Rating Scale (NRS)
Time Frame: 12 Months
|
it is a simple and widely used tool for measuring pain intensity.
It consists of a horizontal line with 11 numbered points, ranging from 0 (no pain) to 10 (worst pain imaginable).
Patients are asked to rate their pain by selecting the number that best describes their current pain intensity
|
12 Months
|
|
The Oswestry Disability Index (ODI)
Time Frame: 12 months
|
it is a patient-completed questionnaire used to measure the level of disability caused by low back pain.
It is a widely used and validated tool in both research and clinical settings.
Studies show high test-retest reliability of 0.90
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
April 29, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
May 20, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 24, 2024
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSRSW/Batch-Fall22/713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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