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

NCT06260631 | Completed

• 1 other identifier: P.T.REC/012/004807
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Nonspecific Low-back Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• peak torque

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

  up to four weeks

• peak torque

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

  follow up after 1 month

• Average Power

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

  up to four weeks

• Average Power

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

  follow up after 1 month

Secondary Outcomes (8)

• Pain Intensity

  up to four weeks

• Pain Intensity

  follow up after 1 month

• lumbar flexion and extension ROM assessment

  up to four weeks

• lumbar flexion and extension ROM assessment

  follow up after 1 month

• Disability

  up to four weeks

Study Arms (2)

high-intensity laser acupuncture and an exercise therapy program.

EXPERIMENTAL

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 laser acupuncture and an exercise therapy program.

SHAM COMPARATOR

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

high-intensity laser acupuncture and Exercise therapy 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. 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

high-intensity laser acupuncture and an exercise therapy program.

Sham laser acupuncture OTHER

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.

sham laser acupuncture and an exercise therapy program.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 anti-inflammatory 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.

Sponsors & Collaborators

• Cairo University: lead
• King Khalid University: collaborator

Study Sites (1)

Doaa Ayoub Elimy

Giza, 11251, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: random generator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of physical therapy for basic science department., faculty of physical Therapy

Model Details: high-intensity laser acupuncture and exercise therapy program

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 15, 2024
• Study Start: February 25, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

EG (1)