Clinical trial NCT06280846: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain
Official title: High-intensity Versus Low-intensity Laser Acupuncture in 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
Low-intensity laser acupuncture
peak torque
fatigue
functional disability
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: King Khalid University
First posted: 2024-02-28
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, low-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 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.

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

Primary outcomes:
measure: peak torque
timeFrame: up to four weeks
measure: peak torque
timeFrame: follow up after 1 month
measure: Fatigue
timeFrame: up to four weeks
measure: Fatigue
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 ROM assessment
timeFrame: up to four weeks
measure: lumbar flexion ROM assessment
timeFrame: follow up after 1 month
measure: Disability
timeFrame: up to four weeks
measure: Disability
timeFrame: follow up after 1 month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Doaa Ayoub Elimy
Study officials:
References: