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

High-intensity Versus Low-intensity Laser Acupuncture in 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 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).

Study Overview

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

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 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 patients 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
Experimental: Experimental low-intensity laser acupuncture and an exercise therapy program.; The patients will receive low-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.	Device: low-intensity laser acupuncture and Exercise therapy program; The patients will receive low-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: low power laser
Sham Comparator: sham laser acupuncture and an exercise therapy program.; The patients will receive a sham laser acupuncture and an exercise therapy program three times a week for four weeks.	Device: 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.	up to four weeks
peak torque	Isokinetic dynamometer will be used for measuring peak torque of back extensors.	follow up after 1 month
Fatigue	Isokinetic dynamometer will be used for measuring fatigue of back extensors.	up to four weeks
Fatigue	Isokinetic dynamometer will be used for measuring fatigue of back extensors.	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 ROM assessment	Modified Schober test will be used to assess ROM of lumbar flexion.	up to four weeks
lumbar flexion ROM assessment	Modified Schober test will be used to assess ROM of lumbar flexion.	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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: King Khalid University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): 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: fatigue; low back pain; functional disability; peak torque; high-intensity laser acupuncture; Low-intensity laser acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/004878

Drug and device information, study documents

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