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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Nonspecific Low-back Pain
• Intervention / Treatment: Device: high-intensity laser acupuncture and Exercise therapy program; Other: Sham laser acupuncture

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doaa A Elimy, lecturer; Phone Number: 00201066474654; Email: do3aayoub25@gmail.com

Study Locations

• Egypt
  • Giza, Egypt, 11251
    • Recruiting
    • Doaa Ayoub Elimy
    • Contact: Doaa A Elimy, lecturer; Phone Number: 00201066474654; Email: do3aayoub25@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-intensity laser acupuncture and an exercise therapy program.; The patients will receive high-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.	Device: high-intensity laser acupuncture and Exercise therapy program; 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.; Other Names: high-power laser acupuncture
Sham Comparator: sham laser acupuncture and an exercise therapy program.; The patients will receive a sham acupuncture laser and an exercise therapy program three times a week for four weeks.	Other: Sham 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peak torque	Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors.	up to four weeks
peak torque	Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors..	follow up after 1 month
Average Power	Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.	up to four weeks
Average Power	Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.	follow up after 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	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'.	up to four weeks
Pain Intensity	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'.	follow up after 1 month
lumbar flexion and extension ROM assessment	Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension	up to four weeks
lumbar flexion and extension ROM assessment	Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension	follow up after 1 month
Disability	Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability.	up to four weeks
Disability	Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability.	follow up after 1 month
patient Satisfaction	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'.	up to four weeks
patient Satisfaction	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'.	follow up after 1 month

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: King Khalid University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: low back pain; functional disability; power; peak torque; high-intensity laser acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/004807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No