Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain

Cairo University (CU)

Status: Enrolling

Conditions: Low Back Pain

Treatments: Other: high power laser acupuncture (HPLA); Other: conventional treatment; Other: Sham laser

Study type: Interventional

Funder types: Other

Identifiers

NCT05970419

Tasnim Mohamed Elfeky

Details and patient eligibility

About

This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients?

Full description

The aims of this study are:

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects will be included in this study will be having all of the following 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

1. History of any surgical procedure in the back or the lower extremities.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

High power laser acupuncture group

Experimental group

Description:

This group will receive high power laser acupuncture (HPLA) +conventional therapy

Treatment:

Other: conventional treatment

Other: high power laser acupuncture (HPLA)

Conventional treatment group

Active Comparator group

Description:

This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment.

Treatment:

Other: conventional treatment

Other: Sham laser