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

Not Applicable

Completed

• Conditions: Chronic Nonspecific Low-back Pain
• Interventions: Device: high-intensity laser acupuncture and Exercise therapy program; Device: low-intensity laser acupuncture and Exercise therapy program; Device: Sham laser acupuncture

• Registration Number: NCT06280846
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-02-16
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Study Start: 2024-03-15
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental high-intensity laser acupuncture and an exercise therapy program.	high-intensity laser acupuncture and Exercise therapy program	The patients will receive high-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.
Experimental low-intensity laser acupuncture and an exercise therapy program.	low-intensity laser acupuncture and Exercise therapy program	The patients will receive low-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.
sham laser acupuncture and an exercise therapy program.	Sham laser acupuncture	The patients will receive a sham laser acupuncture and an exercise therapy program three times a week for four weeks.

Primary Outcome Measures

Name	Time	Method
peak torque	follow up after 1 month	Isokinetic dynamometer will be used for measuring peak torque of back extensors.
Fatigue	follow up after 1 month	Isokinetic dynamometer will be used for measuring fatigue of back extensors.

Secondary Outcome Measures

Name	Time	Method
Disability	follow up after 1 month	Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability
lumbar flexion ROM assessment	follow up after 1 month	Modified Schober test will be used to assess ROM of lumbar flexion.
Pain Intensity	follow up after 1 month	Visual 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'.

Trial Locations

Locations (1)

Doaa Ayoub Elimy; 🇪🇬 Giza, Egypt