NCT06428565

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 20, 2024

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Numeric Pain Rating Scale (NRS)

    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)

    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

Study Arms (1)

Low-level laser therapy (LLLT) or cold laser therapy

EXPERIMENTAL

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

Diagnostic Test: Low-level laser therapy (LLLT) or cold laser therapy

Interventions

Low-level laser therapy (LLLT) or cold laser therapy

Low-level laser therapy (LLLT) or cold laser therapy

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with neurological symptoms.
  • Patients diagnosed with fatigue syndrome
  • Females having pregnancy
  • History of low back surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hameed Latif Hospital Lahore

Lahore, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

November 1, 2023

Primary Completion

April 29, 2024

Study Completion

September 1, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations