Chronic Nonspecific Low-back PainNCT06612918
Effect of High-intensity Laser Acupuncture on Muscle Performance, Pain and Quality of Life in Low Back Pain
A study testing high-intensity laser acupuncture and the exercise program in people with Chronic Nonspecific Low-back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life 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 the exercise 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
- 1 Oct 2024to 31 Mar 2025
- 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
Show all 10Show fewer
- use of medication, such as corticosteroids, anticonvulsants, and antiinflammatory 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-Intensity Laser Acupuncture on Muscle Performance, Pain, and Quality of Life in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life in patients with chronic nonspecific low back pain (CNLBP).
Read the detailed description
Chronic non-specific low back pain (CNSLBP) is a persistent back pain that affects people of all ages and significantly impacts individuals' daily activities and quality of life. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. In recent years, high-intensity laser has been used for managing musculoskeletal pain and dysfunction that allows for more energy deposition in deep tissues, resulting in both biological effects and thermal effects. High-intensity laser acupuncture (HILA) has emerged as a promising intervention that combines the therapeutic effects of high-intensity laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting HILA efficacy in the management ofCNSLBP, with only a few studies available. For that, this study aims to investigate the effect of HILA on muscle performance, back pain, and quality of life in patients with CNSLBP. Through this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of muscle performance, back pain, and quality of life.
- Conditions
- Chronic Nonspecific Low-back Pain
- Being tested
- high-intensity laser acupuncture and the exercise program, sham laser acupuncture and the exercises program
- Keywords
- low back pain, high-intensity laser acupuncture, muscle performance, back pain, quality of life
- Medical subject headings
- Low Back Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity laser acupuncture and the exercise programDevice
Also called high-power laser acupuncture
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. 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.
sham laser acupuncture and the exercises programOther
Also called sham laser acupuncture
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.
| Study group | Role | What they receive |
|---|---|---|
| high-intensity laser acupuncture and the exercise program | Experimental | The patients will receive high-intensity laser acupuncture and the exercise program three times a week for four weeks. Receives: Device: high-intensity 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. Receives: Other: sham laser acupuncture and the exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle performance
Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors
Measured: up to four weeks]
muscle performance
Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors
Measured: follow up after 1 month
Secondary outcomes (4)
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
Quality of Life (WHOQOL-BREF)
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) will be used in assessment of quality-of-life.The Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be four domains. The four domain scores will denote an individual perception of quality of life in each particular domain.Domain scores are scaled in a positive direction higher scores denote higher quality of life.
Measured: up to four weeks
Quality of Life (WHOQOL-BREF)
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) will be used in assessment of quality-of-life.The Arabic translation of the WHOQOL-BREF has impressive reliability and validity indices. There will be four domains. The four domain scores will denote an individual perception of quality of life in each particular domain.Domain scores are scaled in a positive direction higher scores denote higher quality of life.
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.
- First posted25 Sep 2024
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 and exercise therapy program
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- King Khalid University
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612918
- Sponsor's protocol ID
- P.T.REC/012/005224
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Intensity Laser Acupuncture on Muscle Performance, Pain, and Quality of Life in Patients With Chronic Nonspecific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06612918
- Acronym / sponsor ID
- P.T.REC/012/005224
- Conditions
- Chronic Nonspecific Low-back Pain
- Keywords
- low back pain, high-intensity laser acupuncture, muscle performance, back pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- King Khalid University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 25 Sep 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.
To investigate the effect of high-intensity laser acupuncture on muscle performance, pain, and quality of life in patients with chronic nonspecific low back pain (CNLBP).
Detailed description
Chronic non-specific low back pain (CNSLBP) is a persistent back pain that affects people of all ages and significantly impacts individuals' daily activities and quality of life. While various treatment modalities exist, there is ongoing interest in exploring novel approaches to manage this condition effectively. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause analgesic effects. In recent years, high-intensity laser has been used for managing musculoskeletal pain and dysfunction that allows for more energy deposition in deep tissues, resulting in both biological effects and thermal effects. High-intensity laser acupuncture (HILA) has emerged as a promising intervention that combines the therapeutic effects of high-intensity laser therapy and the principles of acupuncture point stimulation on the body (acupoints) to induce physiological effect. However, there is limited evidence supporting HILA efficacy in the management ofCNSLBP, with only a few studies available. For that, this study aims to investigate the effect of HILA on muscle performance, back pain, and quality of life in patients with CNSLBP. Through this current randomized controlled trial, we seek to provide evidence-based insights into the potential effects of this combined approach on measurements of muscle performance, back pain, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- high-intensity laser acupuncture and exercise therapy program
| Arm | Type | Receives |
|---|---|---|
| high-intensity laser acupuncture and the exercise program | Experimental | Device: high-intensity laser acupuncture and the exercise programThe patients will receive high-intensity laser acupuncture and the exercise program three times a week for four weeks. |
| sham laser acupuncture and exercises program. | Sham comparator | Other: sham laser acupuncture and the exercises programThe patients will receive sham acupuncture laser and the exercise 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 (10 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 the exercise programAlso: high-power laser acupunctureThe 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. 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. | Device | high-intensity laser acupuncture and the exercise program |
| sham laser acupuncture and the exercises programAlso: sham laser acupunctureThe 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. | Other | sham laser acupuncture and exercises program. |
Primary outcome
muscle performance
Time frame: up to four weeks]
Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors
muscle performance
Time frame: follow up after 1 month
Isokinetic dynamometer will be used for measuring muscle performance of back extensors and flexors
4 secondary outcomes
Pain Intensity
Time frame: up to four weeks
Pain Intensity
Time frame: follow up after 1 month
Quality of Life (WHOQOL-BREF)
Time frame: up to four weeks
Quality of Life (WHOQOL-BREF)
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 15 Apr 2025.
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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?
A study testing high-intensity laser acupuncture and the exercise program in people with Chronic Nonspecific Low-back Pain, run by Cairo University at 1 site in Egypt.
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 10 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 15 Apr 2025. 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?
muscle performance (time frame: up to four weeks]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.