Clinical trial NCT06260631: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain
Official title: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low-back Pain
Keywords: low back pain
high-intensity laser acupuncture
peak torque
power
functional disability
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: high-intensity laser acupuncture and exercise therapy program
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: peak torque
timeFrame: up to four weeks
measure: peak torque
timeFrame: follow up after 1 month
measure: Average Power
timeFrame: up to four weeks
measure: Average Power
timeFrame: follow up after 1 month
Secondary outcomes:
measure: Pain Intensity
timeFrame: up to four weeks
measure: Pain Intensity
timeFrame: follow up after 1 month
measure: lumbar flexion and extension ROM assessment
timeFrame: up to four weeks
measure: lumbar flexion and extension ROM assessment
timeFrame: follow up after 1 month
measure: Disability
timeFrame: up to four weeks
measure: Disability
timeFrame: follow up after 1 month
measure: patient Satisfaction
timeFrame: up to four weeks
measure: patient Satisfaction
timeFrame: follow up after 1 month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Doaa Ayoub Elimy
Study officials:
References: