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Completed

NCT Number: NCT06260631

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

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).

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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 (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.

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
  • use of medication, such as corticosteroids, anticonvulsants, and anti-inflammatory drugs that may affect the outcome of the study.
  • prior history of adverse effects to physical stimulation therapy.
  • significant physical or mental deficiencies preventing a clear understanding of the study procedure.
  • spinal stenosis, thyroid dysfunctions, obesity, pace-maker.

Treatment and study plan

high-intensity laser acupuncture and Exercise therapy program

Device

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 laser acupuncture

Other

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 and flexors.

  2. peak torque

    Time frame: follow up after 1 month

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

  3. Average Power

    Time frame: up to four weeks

    Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.

  4. Average Power

    Time frame: follow up after 1 month

    Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.

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 and extension ROM assessment

    Time frame: up to four weeks

    Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension

  4. lumbar flexion and extension ROM assessment

    Time frame: follow up after 1 month

    Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension

  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.

  7. patient Satisfaction

    Time frame: up to four weeks

    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'.

  8. patient Satisfaction

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • King Khalid University

Registry information

Official study title

Efficacy of High-intensity Laser Acupuncture in Patients With 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 15, 2024
Registry last updated
Sep 23, 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.

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