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

Efficacy of High-intensity Laser Acupuncture in Patients With Chronic Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06260631
Enrollment
60
Registered
2024-02-15
Start date
2024-02-25
Completion date
2024-08-31
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Nonspecific Low-back Pain

Keywords

low back pain, high-intensity laser acupuncture, peak torque, power, functional disability

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.

Interventions

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.

OTHERSham 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.

Sponsors

King Khalid University
CollaboratorOTHER
Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

random generator

Intervention model description

high-intensity laser acupuncture and exercise therapy program

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
peak torqueup to four weeksIsokinetic dynamometer will be used for measuring peak torque of back extensors and flexors.
Average Powerup to four weeksIsokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.

Secondary

MeasureTime frameDescription
Pain Intensityup to four weeksVisual Analogue Scale (VAS) will be used by the patient to mark his/her level of pain between 0 to100 milliliters line. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
lumbar flexion and extension ROM assessmentup to four weeksModified-modified Schober test will be used to assess ROM of lumbar flexion and extension
Disabilityup to four weeksArabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability.
patient Satisfactionup to four weeksThe satisfaction VAS will be used to measure patient satisfaction. The patient will be by placing an indicator at 0 to100 milliliters line. Zero usually represents 'no satisfaction at all' whereas the upper limit represents 'the best satisfaction ever'.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026