High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain

NCT ID: NCT06280846

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-10-30

Brief Summary

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP).

Detailed Description

Chronic nonspecific low back pain is a type of persistent back pain that affects people of all ages and contributes to the global disease burden (CNLBP). The major objective of treatment is to lessen pain and its aftereffects. One noninvasive, targeted light therapy for treating musculoskeletal disorders is low-intensity laser therapy (LLLT). It has analgesic, anti-inflammatory, muscle-relaxant, and tissue-repair properties. Additionally, LILT has been demonstrated to relieve generalized lower back pain. Another light therapy that is painless and noninvasive, high-intensity laser therapy (HILT), stimulates tissue while delivering analgesic, anti-inflammatory, and anti-edematous benefits. It has been demonstrated that acupuncture, a popular complementary therapy, can relieve musculoskeletal pain and increase muscle strength.To date, however, there has been limited investigation into the effects of high- versus low-intensity laser acupuncture on CNLBP. Thus, the current study will be conducted to explore the efficacy of HILT versus LILL on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and functional disability in patients with chronic, nonspecific low back pain.

Conditions

Chronic Nonspecific Low-back Pain

Study Design

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

Study Groups

Experimental high-intensity laser acupuncture and an exercise therapy program.

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

Group Type: EXPERIMENTAL

high-intensity laser acupuncture and Exercise therapy program

Intervention Type: DEVICE

The patients 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.

Exercise therapy program: The patients will perform an exercise therapy program in the form of:

• strengthening exercises for abdominal and back muscles, - lumbar stabilization exercises. - stretching exercises

Experimental low-intensity laser acupuncture and an exercise therapy program.

The patients will receive low-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.

Group Type: EXPERIMENTAL

low-intensity laser acupuncture and Exercise therapy program

Intervention Type: DEVICE

The patients will receive low-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.

Exercise therapy program: The patients will perform an exercise therapy program in the form of:

• strengthening exercises for abdominal and back muscles, - lumbar stabilization exercises. - stretching exercises

sham laser acupuncture and an exercise therapy program.

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

Group Type: SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type: DEVICE

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

Interventions

high-intensity laser acupuncture and Exercise therapy program

The patients 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.

Exercise therapy program: The patients will perform an exercise therapy program in the form of:

• strengthening exercises for abdominal and back muscles, - lumbar stabilization exercises. - stretching exercises

Intervention Type: DEVICE

low-intensity laser acupuncture and Exercise therapy program

The patients will receive low-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.

Exercise therapy program: The patients will perform an exercise therapy program in the form of:

• strengthening exercises for abdominal and back muscles, - lumbar stabilization exercises. - stretching exercises

Intervention Type: DEVICE

Sham laser acupuncture

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

Intervention Type: DEVICE

Other Intervention Names

high-power laser acupuncture; low power laser

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

• 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

Doaa Ayoub Elimy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004878

Identifier Type: -

Identifier Source: org_study_id