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| Name | Class |
|---|---|
| King Khalid University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high-intensity laser acupuncture and the exercise program | Experimental | The patients will receive high-intensity laser acupuncture and the exercise program three times a week for four weeks. |
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| sham laser acupuncture and exercises program. | Sham Comparator | The patients will receive sham acupuncture laser and the exercise program three times a week for four weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| muscle performance | Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors | up to four weeks] |
| muscle performance | Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors | follow up after 1 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Egypt | Giza | 11251 | Egypt |
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high-intensity laser acupuncture and exercise therapy program
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random generator
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| 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. |
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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 |
| Quality of Life (WHOQOL-BREF) | 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. | up to four weeks |
| Quality of Life (WHOQOL-BREF) | 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. | follow up after 1 month |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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