NCT06487338

Brief Summary

A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 27, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

December 26, 2025

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

June 27, 2024

Last Update Submit

December 23, 2025

Conditions

Keywords

Low-level laser therapyShock wave therapyPainFunctionChronic Non-Specific Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • Oswestry low back disability questionnaire

    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome toolsFor each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement)

    30 minutes

  • Back pain functional scale

    The Back Pain Functional Scale (BPFS) is a subjective scale used to measure the patient's physical function after low back painThis scale consists of a total score of 60. Moreover, the patient's score can be measured from the responses obtained on the Likert scale (0 to 5), and accordingly, a total score is summed up out of 60. Furthermore, the maximum score obtained indicates the maximum physical abilities of the patients. In addition, this scale also has an 'Adjusted score' ranging from 0 (0%)-unable to perform any activity to 60 (100%)-no difficulty in any activity

    20 minutes

  • Visual analogue scale

    Visual analogue scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. Visual analogue scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end.48 Patients are instructed to place a mark on the line indicating the amount of pain that they feel at the time of the evaluation. The distance of this mark from the left end is then measured, and this number is used as a numeric representation of the severity of the patient's pain

    5 minutes

Study Arms (2)

Group A

EXPERIMENTAL

Twenty patients will receive low-level laser therapy 3 times per week for a month

Other: Low-level laser therapy

Group B

EXPERIMENTAL

Twenty patients will receive shock wave therapy 3 times per week for a month

Other: Shock wave Therapy

Interventions

Is a form of medicine that applies low-level (low-power) lasers that relieve pain.The effects appear to be limited to a specified set of wavelengths

Group A

is a non-invasive treatment that stimulates the body's natural healing process. It can relieve pain and promote healing of injured tendons, ligaments, and other soft tissues

Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patients will suffer from mechanical low back pain
  • Age will range from 20 to 40 years
  • All patients will have BMI range from 20-24

You may not qualify if:

  • History of radicular pain
  • Lumbar disc prolapse.
  • Visual problems
  • History of previous lumbar surgery
  • BMI more than 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, 11742, Egypt

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

Low-Level Light TherapyExtracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapyUltrasonic TherapyDiathermyHyperthermia, InducedPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for neurology

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 5, 2024

Study Start

August 25, 2024

Primary Completion

October 20, 2024

Study Completion

January 20, 2025

Last Updated

December 26, 2025

Record last verified: 2024-07

Locations