Chronic Nonspecific Low-back PainNCT06260631
Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain
A study testing high-intensity laser acupuncture and Exercise therapy program in people with Chronic Nonspecific Low-back Pain, run by Cairo University at 1 site in Egypt.
Trial 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). 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
- 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
- 25 Feb 2024to 31 Aug 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial
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).
Read the detailed description
Chronic nonspecific low back pain (CNLBP) is a persistent back pain that affects people of all ages and contributes to the global disease burden. Treatment focuses on reducing pain and its consequences. High-intensity laser therapy is a non-invasive, painless modality that can be easily administered for various conditions. It has been proven to significantly reduce pain, with anti-inflammatory, anti-edematous, and analgesic effects. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause vasodilation and analgesic effects. Acupuncture is a common complementary therapy that has been proven to treat musculoskeletal pain and enhance muscle strength, and high-intensity laser acupuncture (HILA) has been promoted as an alternative to traditional needle acupuncture. HILA, as a non-invasive treatment, combines the efficacy of high-intensity laser and acupuncture in musculoskeletal pain management. Due to a lack of research, this study will examine the effects of HILA on peak torque and power of the trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic non-specific low back pain.
- Conditions
- Chronic Nonspecific Low-back Pain
- Being tested
- high-intensity laser acupuncture and Exercise therapy program, Sham laser acupuncture
- Keywords
- low back pain, high-intensity laser acupuncture, peak torque, power, functional disability
- Medical subject headings
- Low 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 Exercise therapy 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.
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 acupunctureOther
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 group | Role | What they receive |
|---|---|---|
| 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 |
| 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. Receives: Other: 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 and flexors.
Measured: up to four weeks
peak torque
Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors..
Measured: follow up after 1 month
Average Power
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
Measured: up to four weeks
Average Power
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
Measured: follow up after 1 month
Secondary outcomes (8)
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 and extension ROM assessment
Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension
Measured: up to four weeks
lumbar flexion and extension ROM assessment
Modified-modified Schober test will be used to assess ROM of lumbar flexion and extension
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
patient Satisfaction
The satisfaction VAS will be used to measure patient satisfaction. The patient will be by placing an indicator at 0 to100 milliliters line. Zero usually represents 'no satisfaction at all' whereas the upper limit represents 'the best satisfaction ever'.
Measured: up to four weeks
patient Satisfaction
The satisfaction VAS will be used to measure patient satisfaction. The patient will be by placing an indicator at 0 to100 milliliters line. Zero usually represents 'no satisfaction at all' whereas the upper limit represents 'the best satisfaction ever'.
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 posted15 Feb 2024
- Study start25 Feb 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
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
- NCT06260631
- Sponsor's protocol ID
- P.T.REC/012/004807
- Status last verified
- Sep 2024
- First submitted
- 5 Feb 2024
- Last updated
- 23 Sep 2024
- 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 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-intensity Laser Acupuncture in Patients With Chronic Non-specific Low Back Pain: a Double-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06260631
- Acronym / sponsor ID
- P.T.REC/012/004807
- Conditions
- Chronic Nonspecific Low-back Pain
- Keywords
- low back pain, high-intensity laser acupuncture, peak torque, power, 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
- 25 Feb 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 15 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.
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).
Detailed description
Chronic nonspecific low back pain (CNLBP) is a persistent back pain that affects people of all ages and contributes to the global disease burden. Treatment focuses on reducing pain and its consequences. High-intensity laser therapy is a non-invasive, painless modality that can be easily administered for various conditions. It has been proven to significantly reduce pain, with anti-inflammatory, anti-edematous, and analgesic effects. Laser photobiomodulation (PBM) therapy is a non-invasive and painless method that stimulates cells, pain receptors, and the immune system and can cause vasodilation and analgesic effects. Acupuncture is a common complementary therapy that has been proven to treat musculoskeletal pain and enhance muscle strength, and high-intensity laser acupuncture (HILA) has been promoted as an alternative to traditional needle acupuncture. HILA, as a non-invasive treatment, combines the efficacy of high-intensity laser and acupuncture in musculoskeletal pain management. Due to a lack of research, this study will examine the effects of HILA on peak torque and power of the trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic non-specific low back pain.
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 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. |
| sham laser acupuncture and an exercise therapy program. | Sham comparator | Other: Sham laser acupunctureThe patients will receive a sham acupuncture laser 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 (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 Exercise therapy 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. 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 | high-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. | Other | 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 and flexors.
peak torque
Time frame: follow up after 1 month
Isokinetic dynamometer will be used for measuring peak torque of back extensors and flexors..
Average Power
Time frame: up to four weeks
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
Average Power
Time frame: follow up after 1 month
Isokinetic dynamometer will be used for measuring Average Power in watts for both back extensors and flexors.
8 secondary outcomes
Pain Intensity
Time frame: up to four weeks
Pain Intensity
Time frame: follow up after 1 month
lumbar flexion and extension ROM assessment
Time frame: up to four weeks
lumbar flexion and extension ROM assessment
Time frame: follow up after 1 month
Disability
Time frame: up to four weeks
Disability
Time frame: follow up after 1 month
patient Satisfaction
Time frame: up to four weeks
patient Satisfaction
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 23 Sep 2024.
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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 Exercise therapy 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 23 Sep 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?
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 23 Sep 2024.