Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain
NCT ID: NCT05970419
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-08-30
2024-04-30
Brief Summary
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Detailed Description
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1. To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients
2. To investigate the effect of high power laser acupuncture on back range of motion (flexion, extension, side bending and rotation) in chronic nonspecific low back pain patients.
3. To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients.
4. To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients.
5. To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients.
6. To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High power laser acupuncture group
This group will receive high power laser acupuncture (HPLA) +conventional therapy
high power laser acupuncture (HPLA)
High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 \& REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t
conventional treatment
Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).
General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.
Conventional treatment group
This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.
conventional treatment
Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).
General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.
Sham laser
sham laser (Not active)
Interventions
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high power laser acupuncture (HPLA)
High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 \& REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t
conventional treatment
Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).
General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.
Sham laser
sham laser (Not active)
Eligibility Criteria
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Inclusion Criteria
1. Age over 18 years of age.
2. Both genders (males and females).
3. Normal BMI ranges between 18.5:24.9 kg/m2.
4. 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.
6\) CNSLBP patients will be diagnosed based on the standard criteria, including pain and tenderness on lower back and a negative result for all special tests for lumber neurological examination.
Exclusion Criteria
2. Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
3. Patient with lumbar instability including spondylolisthesis.
4. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
5. Pregnancy.
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Tasnim Mohamed Elfeky
Principal Investigator
Principal Investigators
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Tasnim Mohamed
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Outpatient clinic faculty of physical therapy cairo university
Dokki, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Outpatient CFOPTC university
Role: primary
Other Identifiers
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Tasnim Mohamed Elfeky
Identifier Type: -
Identifier Source: org_study_id