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

Not Applicable

Recruiting

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

• Registration Number: NCT06260631
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-07
• Study First Posted: 2024-02-15
• Study Start: 2024-02-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• 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
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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
sham laser acupuncture and an exercise therapy program.	Sham laser acupuncture	The patients will receive a sham acupuncture laser 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 and flexors..
Average Power	follow up after 1 month	Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.

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.
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'.
patient Satisfaction	follow up after 1 month	The 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'.
lumbar flexion and extension ROM assessment	follow up after 1 month	Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension

Trial Locations

Locations (1)

Doaa Ayoub Elimy; 🇪🇬 Giza, Egypt