Effect of High-power Laser Acupuncture on Fatigue and Proprioception in Low Back Pain

NCT ID: NCT07196709

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-06-30

Brief Summary

To investigate the effect of high-intensity laser acupuncture on fatigue, proprioception, back pain and Pain self-efficacy 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' functional activities. Fatigue and impaired proprioception are common complaints associated with CNSLBP, contributing to diminished physical performance and exacerbation of symptoms. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively.Laser photobiomodulation (PBM) therapy is a noninvasive that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. Recently, high-power lasers have been used for managing musculoskeletal dysfunction that allows for more energy deposition in deep tissues, resulting in both biological and thermal effects. High-power laser acupuncture (HPLA) has emerged as a promising intervention that combines the therapeutic effects of high-power laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting this combined approach. For that, this study aims to investigate the effect of HPLA on fatigue, proprioception back pain and Pain self-efficacy in patients with CNSLBP. With this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of fatigue, proprioception, back pain and Pain self-efficacy.

Conditions

Chronic Nonspecific Low-back Pain

Study Design

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

Study Groups

high-power laser acupuncture and the exercise program

The patients will receive high-power laser acupuncture and the exercise program three times a week for 4 weeks.

Group Type: EXPERIMENTAL

high-power laser acupuncture and the exercise program

Intervention Type: DEVICE

The experimental group will receive high-power 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: DEVICE

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-power laser acupuncture and the exercise program

The experimental group will receive high-power 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: DEVICE

Other Intervention Names

high-intensity 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 diagnosis with 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 BMI ranges between 18.5:29.9 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

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

Sponsors

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

Doaa Ayoub Elimy

Giza, , Egypt

Countries

Egypt

Central Contacts

Doaa A Elimy, lecturer

Role: CONTACT

do3aayoub25@gmail.com

00201066474654

Facility Contacts

Doaa A Elimy, lecturer

Role: primary

do3aayoub25@gmail.com

00201066474654

Other Identifiers

P.T.REC/012/005223

Identifier Type: -

Identifier Source: org_study_id