Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain

NCT ID: NCT06260631

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-25
• Study Completion Date: 2024-08-31

Brief Summary

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

Detailed Description

Chronic nonspecific low back pain (CNLBP) is a persistent back pain that affects people of all ages and contributes to the global disease burden. Treatment focuses on reducing pain and its consequences. High-intensity laser therapy is a non-invasive, painless modality that can be easily administered for various conditions. It has been proven to significantly reduce pain, with anti-inflammatory, anti-edematous, and analgesic effects. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause vasodilation and analgesic effects. Acupuncture is a common complementary therapy that has been proven to treat musculoskeletal pain and enhance muscle strength, and high-intensity laser acupuncture (HILA) has been promoted as an alternative to traditional needle acupuncture. HILA, as a non-invasive treatment, combines the efficacy of high-intensity laser and acupuncture in musculoskeletal pain management. Due to a lack of research, this study will examine the effects of HILA on peak torque and power of the trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic non-specific 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

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 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.

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 acupuncture laser and an exercise therapy program three times a week for four weeks.

Group Type: SHAM_COMPARATOR

Sham laser acupuncture

Intervention Type: OTHER

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 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.

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: OTHER

Other Intervention Names

high-power 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 anti-inflammatory 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

Doaa Ayoub Elimy

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/004807

Identifier Type: -

Identifier Source: org_study_id