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Completed

NCT Number: NCT06612918

Effect of High-intensity Laser Acupuncture on Muscle Performance, Pain and Quality of Life in Low Back Pain

To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life 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

Egypt

Giza, 11251, Egypt

About this study

Chronic non-specific low back pain (CNSLBP) is a persistent back pain that affects people of all ages and significantly impacts individuals' daily activities and quality of life. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. In recent years, high-intensity laser has been used for managing musculoskeletal pain and dysfunction that allows for more energy deposition in deep tissues, resulting in both biological effects and thermal effects. High-intensity laser acupuncture (HILA) has emerged as a promising intervention that combines the therapeutic effects of high-intensity laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting HILA efficacy in the management ofCNSLBP, with only a few studies available. For that, this study aims to investigate the effect of HILA on muscle performance, back pain, and quality of life in patients with CNSLBP. Through this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of muscle performance, back pain, and quality of life.

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 antiinflammatory 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 the exercise 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. Exercises program: The patients will perform this exercise program in the form of: strengthening exercises for abdominal and back muscles; lumbar stabilization exercises; and stretching exercises.

Other names: high-power laser acupuncture

sham laser acupuncture and the exercises program

Other

The patients will receive a sham laser acupuncture and the exercise program in the form of: strengthening exercises for abdominal and back muscles; lumbar stabilization exercises and stretching exercises.

Other names: sham laser acupuncture

Primary outcomes

  1. muscle performance

    Time frame: up to four weeks]

    Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors

  2. muscle performance

    Time frame: follow up after 1 month

    Isokinetic dynamometer will be used for measuring muscle performance of 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. Quality of Life (WHOQOL-BREF)

    Time frame: up to four weeks

    The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) will be used in assessment of quality-of-life.The Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be four domains. The four domain scores will denote an individual perception of quality of life in each particular domain.Domain scores are scaled in a positive direction higher scores denote higher quality of life.

  4. Quality of Life (WHOQOL-BREF)

    Time frame: follow up after 1 month

    The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) will be used in assessment of quality-of-life.The Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be four domains. The four domain scores will denote an individual perception of quality of life in each particular domain.Domain scores are scaled in a positive direction higher scores denote higher quality of life.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • King Khalid University

Registry information

Official study title

Effect of High-Intensity Laser Acupuncture on Muscle Performance, Pain, and Quality of Life in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2024
Registry last updated
Apr 15, 2025

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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