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

NCT ID: NCT06612918

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-03-31

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).

Detailed Description

Chronic non-specific low back pain (CNSLBP) is a persistent back pain that affects people of all ages and significantly impacts individuals' daily activities and quality of life. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. In recent years, high-intensity laser has been used for managing musculoskeletal pain and dysfunction that allows for more energy deposition in deep tissues, resulting in both biological effects and thermal effects. High-intensity laser acupuncture (HILA) has emerged as a promising intervention that combines the therapeutic effects of high-intensity laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting HILA efficacy in the management ofCNSLBP, with only a few studies available. For that, this study aims to investigate the effect of HILA on muscle performance, back pain, and quality of life in patients with CNSLBP. Through this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of muscle performance, back pain, and quality of life.

Conditions

Chronic Nonspecific Low-back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

high-intensity laser acupuncture and the exercise program

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

Group Type: EXPERIMENTAL

high-intensity laser acupuncture and the exercise program

Intervention Type: 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.

sham laser acupuncture and exercises program.

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

Group Type: SHAM_COMPARATOR

sham laser acupuncture and the exercises program

Intervention Type: 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.

Interventions

high-intensity laser acupuncture and the exercise program

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.

Intervention Type: DEVICE

sham laser acupuncture and the exercises program

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.

Intervention Type: OTHER

Other Intervention Names

high-power laser acupuncture; sham laser acupuncture

Eligibility Criteria

Inclusion Criteria

1. The patients had CNSLBP with age from 20 to 40 years from both genders.

2. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.

3. 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.

4. Patients with normal BMI ranges between 18.5:24.9 kg/m2.

5. The study populations must be willing to participate in the study

Exclusion Criteria

1. Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.

2. Psychiatric/mental deficit.

3. Patients who had a previous surgical history (within 6 months) will also excluded.

4. participation in other treatment within the previous 3 month.

5. Pregnancy.

6. History of spinal fracture, tumor, osteoporosis

7. use of medication, such as corticosteroids, anticonvulsants, and antiinflammatory drugs that may affect the outcome of the study.

8. prior history of adverse effects to physical stimulation therapy.

9. significant physical or mental deficiencies preventing a clear understanding of the study procedure.

10. spinal stenosis, thyroid dysfunctions, obesity, pace-maker.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Khalid University

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Doaa Ayoub Elimy Mohammed

Lecturer of physical therapy for basic science department., faculty of physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Egypt

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005224

Identifier Type: -

Identifier Source: org_study_id