Effect of High-intensity Laser Acupuncture on Muscle Performance, Pain and Quality of Life in Low Back Pain

NCT06612918 | Completed

• 1 other identifier: P.T.REC/012/005224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life in patients with chronic nonspecific low back pain (CNLBP).

Conditions

Chronic Nonspecific Low-back Pain

Keywords

low back pain; high-intensity laser acupuncture; muscle performance; back pain; quality of life

Outcome Measures

Primary Outcomes (2)

• muscle performance

  Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors

  up to four weeks]

• muscle performance

  Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors

  follow up after 1 month

Secondary Outcomes (4)

• Pain Intensity

  up to four weeks

• Pain Intensity

  follow up after 1 month

• Quality of Life (WHOQOL-BREF)

  up to four weeks

• Quality of Life (WHOQOL-BREF)

  follow up after 1 month

Study Arms (2)

high-intensity laser acupuncture and the exercise program

EXPERIMENTAL

The patients will receive high-intensity laser acupuncture and the exercise program three times a week for four weeks.

Device: high-intensity laser acupuncture and the exercise program

sham laser acupuncture and exercises program.

SHAM COMPARATOR

The patients will receive sham acupuncture laser and the exercise program three times a week for four weeks.

Other: sham laser acupuncture and the exercises program

Interventions

high-intensity laser acupuncture and the exercise program DEVICE

The experimental group will receive high-intensity lasers, and the treatment will be performed at 15 acupuncture points: unilateral GV3, GV4, and GV5, and bilateral BL 20, BL23, BL24, BL25, BL40, and GB30. Exercises program: The patients will perform this exercise program in the form of: strengthening exercises for abdominal and back muscles; lumbar stabilization exercises; and stretching exercises.

Also known as: high-power laser acupuncture

high-intensity laser acupuncture and the exercise program

sham laser acupuncture and the exercises program OTHER

The patients will receive a sham laser acupuncture and the exercise program in the form of: strengthening exercises for abdominal and back muscles; lumbar stabilization exercises and stretching exercises.

Also known as: sham laser acupuncture

sham laser acupuncture and exercises program.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patients had CNSLBP with age from 20 to 40 years from both genders.
• Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
• The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.
• Patients with normal BMI ranges between 18.5:24.9 kg/m2.
• The study populations must be willing to participate in the study

You may not qualify if:

• Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
• Psychiatric/mental deficit.
• Patients who had a previous surgical history (within 6 months) will also excluded.
• participation in other treatment within the previous 3 month.
• Pregnancy.
• History of spinal fracture, tumor, osteoporosis
• use of medication, such as corticosteroids, anticonvulsants, and antiinflammatory drugs that may affect the outcome of the study.
• prior history of adverse effects to physical stimulation therapy.
• significant physical or mental deficiencies preventing a clear understanding of the study procedure.
• spinal stenosis, thyroid dysfunctions, obesity, pace-maker.

Sponsors & Collaborators

• Cairo University: lead
• King Khalid University: collaborator

Study Sites (1)

Egypt

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for basic science department., faculty of physical Therapy

Model Details: high-intensity laser acupuncture and exercise therapy program

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

EG (1)