NCT07196709

Brief Summary

To investigate the effect of high-intensity laser acupuncture on fatigue, proprioception, back pain and Pain self-efficacy in patients with chronic nonspecific low back pain (CNLBP).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Nov 2025Jun 2026

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

September 20, 2025

Last Update Submit

March 1, 2026

Conditions

Keywords

low back painhigh-power laser acupuncturefatigueproprioceptionPain self-efficacy

Outcome Measures

Primary Outcomes (3)

  • fatigue

    Isokinetic dynamometer will be used for measuring fatigue of back muscles.

    up to six weeks

  • fatigue

    The Biering-Sørensen test will be used for measuring fatigue of back muscles

    up to six weeks

  • proprioception

    Isokinetic dynamometer will be used for assessing lumber proprioception

    up to six weeks

Secondary Outcomes (2)

  • Pain Intensity

    up to six weeks

  • Pain-Related Self-Efficacy

    up to six weeks

Study Arms (2)

high-power laser acupuncture and the exercise program

EXPERIMENTAL

The patients will receive high-power laser acupuncture and the exercise program three times a week for 4 weeks.

Device: high-power laser acupuncture and the exercise program

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.

Device: sham laser acupuncture and the exercises program

Interventions

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.

Also known as: sham laser acupuncture
sham laser acupuncture and exercises program

The experimental group will receive high-power 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

Also known as: high-intensity laser acupuncture
high-power laser acupuncture and the exercise program

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. The patients had CNSLBP with age from 20 to 40 years from both genders.
  • \. Patients diagnosis with 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 BMI ranges between 18.5:29.9 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Doaa Ayoub Elimy

Giza, 11251, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back PainFatigue

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Doaa A Elimy, lecturer

CONTACT

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
Model Details: high-power laser acupuncture and exercise therapy program
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for basic science department., faculty of physical Therapy

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start

November 30, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations