Chronic Nonspecific Low-back PainNCT06280846

High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain

A study testing high-intensity laser acupuncture and Exercise therapy program and low-intensity laser acupuncture and Exercise therapy program in people with Chronic Nonspecific Low-back Pain, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP). Read more about this study

Who is it for?: Ages 20 to 40 years
Conditions the study is for: Chronic Nonspecific Low-back Pain
What is being tested?: high-intensity laser acupuncture and Exercise therapy program and low-intensity laser acupuncture and Exercise therapy program
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 15 Mar 2024to 30 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Doaa Ayoub Elimy
Giza, 11251

Other trials in Egypt

About this study

Official title: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial

Read the detailed description

Chronic nonspecific low back pain is a type of persistent back pain that affects people of all ages and contributes to the global disease burden (CNLBP). The major objective of treatment is to lessen pain and its aftereffects. One noninvasive, targeted light therapy for treating musculoskeletal disorders is low-intensity laser therapy (LLLT). It has analgesic, anti-inflammatory, muscle-relaxant, and tissue-repair properties. Additionally, LILT has been demonstrated to relieve generalized lower back pain. Another light therapy that is painless and noninvasive, high-intensity laser therapy (HILT), stimulates tissue while delivering analgesic, anti-inflammatory, and anti-edematous benefits. It has been demonstrated that acupuncture, a popular complementary therapy, can relieve musculoskeletal pain and increase muscle strength.To date, however, there has been limited investigation into the effects of high- versus low-intensity laser acupuncture on CNLBP. Thus, the current study will be conducted to explore the efficacy of HILT versus LILL on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and functional disability in patients with chronic, nonspecific low back pain.

Conditions: Chronic Nonspecific Low-back Pain
Being tested: high-intensity laser acupuncture and Exercise therapy program, low-intensity laser acupuncture and Exercise therapy program, Sham laser acupuncture
Keywords: low back pain, high-intensity laser acupuncture, Low-intensity laser acupuncture, peak torque, fatigue, functional disability
Medical subject headings: Low Back Pain, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

high-intensity laser acupuncture and Exercise therapy programDevice
Also called high-power laser acupuncture
The patients 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
low-intensity laser acupuncture and Exercise therapy programDevice
Also called low power laser
The patients will receive low-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
Sham laser acupunctureDevice
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

Study groups in NCT06280846
Study group	Role	What they receive
Experimental 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. Receives: Device: high-intensity laser acupuncture and Exercise therapy program
Experimental low-intensity laser acupuncture and an exercise therapy program.	Experimental	The patients will receive low-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks. Receives: Device: low-intensity laser acupuncture and Exercise therapy program
sham laser acupuncture and an exercise therapy program.	Sham comparator	The patients will receive a sham laser acupuncture and an exercise therapy program three times a week for four weeks. Receives: Device: Sham laser acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

peak torque
Isokinetic dynamometer will be used for measuring peak torque of back extensors.
Measured: up to four weeks
peak torque
Isokinetic dynamometer will be used for measuring peak torque of back extensors.
Measured: follow up after 1 month
Fatigue
Isokinetic dynamometer will be used for measuring fatigue of back extensors.
Measured: up to four weeks
Fatigue
Isokinetic dynamometer will be used for measuring fatigue of back extensors.
Measured: follow up after 1 month

Secondary outcomes (6)

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'.
Measured: up to four weeks
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'.
Measured: follow up after 1 month
lumbar flexion ROM assessment
Modified Schober test will be used to assess ROM of lumbar flexion.
Measured: up to four weeks
lumbar flexion ROM assessment
Modified Schober test will be used to assess ROM of lumbar flexion.
Measured: follow up after 1 month
Disability
Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability
Measured: up to four weeks
Disability
Arabic version of Oswestry Disability Index (ODI) will be used for assessment of functional disability
Measured: follow up after 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202430 Oct 2024

First posted28 Feb 2024
Study start15 Mar 2024
Primary completion30 Oct 2024
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Nonspecific Low-back PainStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06280846
Sponsor's protocol ID: P.T.REC/012/004878
Status last verified: Nov 2024
First submitted: 16 Feb 2024
Last updated: 12 Nov 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Elimy DA, Allah NHN, Abdelwahed NAG, Elabd AM, Allam NM, Moustafa EBS, Almohaimeed HM, Shukry M, Gebba MA, El-Sherbiny M, Alanazi AO, Abdelrahman MMA, Nassif AA. High-intensity versus low-intensity laser acupuncture in chronic, non-specific low back pain: a double-blinded, randomized controlled trial. Front Med (Lausanne). 2026 Jul 15;13:1857622. doi: 10.3389/fmed.2026.1857622. eCollection 2026.
PubMed 42528905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Nonspecific Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06280846
Acronym / sponsor ID: P.T.REC/012/004878
Conditions: Chronic Nonspecific Low-back Pain
Keywords: low back pain, high-intensity laser acupuncture, Low-intensity laser acupuncture, peak torque, fatigue, functional disability
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Collaborators: King Khalid University
Study start: 15 Mar 2024 (actual)
Primary completion: 30 Oct 2024 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 28 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: high-intensity laser acupuncture, low-intensity laser acupuncture and exercise therapy program

Arm	Type	Receives
Experimental high-intensity laser acupuncture and an exercise therapy program.	Experimental	Device: high-intensity laser acupuncture and Exercise therapy programThe patients will receive high-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.
Experimental low-intensity laser acupuncture and an exercise therapy program.	Experimental	Device: low-intensity laser acupuncture and Exercise therapy programThe patients will receive low-intensity laser acupuncture and an exercise therapy program.three times a week for four weeks.
sham laser acupuncture and an exercise therapy program.	Sham comparator	Device: Sham laser acupunctureThe patients will receive a sham laser acupuncture and an exercise therapy program three times a week for four weeks.

Who may qualify

Ages: 20 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
high-intensity laser acupuncture and Exercise therapy programAlso: high-power laser acupunctureThe patients 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	Device	Experimental high-intensity laser acupuncture and an exercise therapy program.
low-intensity laser acupuncture and Exercise therapy programAlso: low power laserThe patients will receive low-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	Device	Experimental low-intensity laser acupuncture and an exercise therapy program.
Sham laser acupunctureSham 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	Device	sham laser acupuncture and an exercise therapy program.

Primary outcome

peak torque
Time frame: up to four weeks
Isokinetic dynamometer will be used for measuring peak torque of back extensors.
peak torque
Time frame: follow up after 1 month
Isokinetic dynamometer will be used for measuring peak torque of back extensors.
Fatigue
Time frame: up to four weeks
Isokinetic dynamometer will be used for measuring fatigue of back extensors.
Fatigue
Time frame: follow up after 1 month
Isokinetic dynamometer will be used for measuring fatigue of back extensors.

6 secondary outcomes

Pain Intensity
Time frame: up to four weeks
Pain Intensity
Time frame: follow up after 1 month
lumbar flexion ROM assessment
Time frame: up to four weeks
lumbar flexion ROM assessment
Time frame: follow up after 1 month
Disability
Time frame: up to four weeks
Disability
Time frame: follow up after 1 month

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Derived from this study: PubMed 42528905Elimy DA, Allah NHN, Abdelwahed NAG, Elabd AM, Allam NM, Moustafa EBS, Almohaimeed HM, Shukry M, Gebba MA, El-Sherbiny M, Alanazi AO, Abdelrahman MMA, Nassif AA. High-intensity versus low-intensity laser acupuncture in chronic, non-specific low back pain: a double-blinded, randomized controlled trial. Front Med (Lausanne). 2026 Jul 15;13:1857622. doi: 10.3389/fmed.2026.1857622. eCollection 2026.

Related trials for Chronic Nonspecific Low-back Pain

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Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peak torque (time frame: up to four weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06280846, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.