CClinicalTrials.gg
CompletedNCT06260631Updated Sep 23, 2024

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

An interventional study of high-intensity laser acupuncture and Exercise therapy program and Sham laser acupuncture in Chronic Nonspecific Low-back Pain, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Chronic Nonspecific Low-back Pain

Keywords

  • low back pain
  • high-intensity laser acupuncture
  • peak torque
  • power
  • functional disability
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Devicehigh-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.

    Also known as: high-power laser acupuncture

  • OtherSham 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.

06

What researchers measure

Primary outcomes

  1. peak torque

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

    Time frame: up to four weeks

  2. peak torque

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

    Time frame: follow up after 1 month

  3. Average Power

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

    Time frame: up to four weeks

  4. Average Power

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

    Time frame: follow up after 1 month

Secondary outcomes

  1. 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'.

    Time frame: up to four weeks

  2. 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'.

    Time frame: follow up after 1 month

  3. lumbar flexion and extension ROM assessment

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

    Time frame: up to four weeks

  4. lumbar flexion and extension ROM assessment

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

    Time frame: follow up after 1 month

  5. Disability

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

    Time frame: up to four weeks

  6. Disability

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

    Time frame: follow up after 1 month

  7. 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'.

    Time frame: up to four weeks

  8. 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'.

    Time frame: follow up after 1 month

07

Study locations

1 site
  • Doaa Ayoub Elimy
    Giza, 11251, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06260631
Lead sponsor
Cairo University
Collaborators
King Khalid University
Responsible party
Doaa Ayoub Elimy Mohammed (Lecturer of physical therapy for basic science department., faculty of physical Therapy, Cairo University) — Principal investigator
First posted
Feb 15, 2024
Start date
Feb 25, 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024
Last update
Sep 23, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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