Skip to main content
OpenTrials
Completed

NCT Number: NCT06280846

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Doaa Ayoub Elimy

Giza, 11251, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients had CNSLBP with age from 20 to 40 years from both genders.
  • Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
  • 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.
  • Patients with normal BMI ranges between 18.5:24.9 kg/m2.
  • The study populations must be willing to participate in the study

Exclusion criteria

  • Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
  • Psychiatric/mental deficit.
  • Patients who had a previous surgical history (within 6 months) will also excluded.
  • participation in other treatment within the previous 3 month.
  • Pregnancy.
  • History of spinal fracture, tumor, osteoporosis

Treatment and study plan

high-intensity laser acupuncture and Exercise therapy program

Device

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

low-intensity laser acupuncture and Exercise therapy program

Device

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 laser acupuncture

Device

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

Primary outcomes

  1. peak torque

    Time frame: up to four weeks

    Isokinetic dynamometer will be used for measuring peak torque of back extensors.

  2. peak torque

    Time frame: follow up after 1 month

    Isokinetic dynamometer will be used for measuring peak torque of back extensors.

  3. Fatigue

    Time frame: up to four weeks

    Isokinetic dynamometer will be used for measuring fatigue of back extensors.

  4. Fatigue

    Time frame: follow up after 1 month

    Isokinetic dynamometer will be used for measuring fatigue of back extensors.

Secondary outcomes

  1. Pain Intensity

    Time frame: up to four weeks

    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'.

  2. Pain Intensity

    Time frame: 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'.

  3. lumbar flexion ROM assessment

    Time frame: up to four weeks

    Modified Schober test will be used to assess ROM of lumbar flexion.

  4. lumbar flexion ROM assessment

    Time frame: follow up after 1 month

    Modified Schober test will be used to assess ROM of lumbar flexion.

  5. Disability

    Time frame: up to four weeks

    Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability

  6. Disability

    Time frame: follow up after 1 month

    Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • King Khalid University

Registry information

Official study title

High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.