Low Back PainNCT05970419
Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain
A study testing high power laser acupuncture (HPLA) and conventional treatment in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients? Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- high power laser acupuncture (HPLA) and conventional treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 30 Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be included in this study will be having all of the following criteria:
- Age over 18 years of age.
- Both genders (males and females).
- Normal BMI ranges between 18.5:24.9 kg/m2.
- 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.
- 6) CNSLBP patients will be diagnosed based on the standard criteria, including pain and tenderness on lower back and a negative result for all special tests for lumber neurological examination.
Who cannot join
- History of any surgical procedure in the back or the lower extremities.
- Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
- Patient with lumbar instability including spondylolisthesis.
- Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic faculty of physical therapy cairo university
Dokki
Outpatient CFOPTC university, eth.com@pt.cu.edu.eg
About this study
This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients?
Read the detailed description
The aims of this study are:
- To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients
- To investigate the effect of high power laser acupuncture on back range of motion (flexion, extension, side bending and rotation) in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.
- Conditions
- Low Back Pain
- Being tested
- high power laser acupuncture (HPLA), conventional treatment, Sham laser
- Keywords
- chronic Low Back pain, high-intensity laser therapy, high power laser acupuncture
- 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 power laser acupuncture (HPLA)Other
High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 \& REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t
conventional treatmentOther
Superficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE).
General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used.
Sham laserOther
sham laser (Not active)
| Study group | Role | What they receive |
|---|---|---|
| High power laser acupuncture group | Experimental | This group will receive high power laser acupuncture (HPLA) +conventional therapy Receives: Other: high power laser acupuncture (HPLA); Other: conventional treatment |
| Conventional treatment group | Active comparator | This group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment. Receives: Other: conventional treatment; Other: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in intensity of pain
By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in Back Range of Motion
By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in Quality of Life
By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life.
The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in endurance of the trunk extensor muscles
By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table.
The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.
Measured: at baseline and after 4 weeks of intervention
Assessing the change in patient satisfaction
By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: "internal," relating to the patient-therapist interaction, and "external," describing no therapist issues such as admissions and clinic environment.
Measured: at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start30 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasnim Mohamed Elfeky, Cairo University
- Investigators
- Tasnim Mohamed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970419
- Sponsor's protocol ID
- Tasnim Mohamed Elfeky
- Status last verified
- Dec 2023
- First submitted
- 24 Jul 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Non-Invasive High Power Laser Acupuncture Stimulation In Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05970419
- Acronym / sponsor ID
- Tasnim Mohamed Elfeky
- Conditions
- Low Back Pain
- Keywords
- chronic Low Back pain, high-intensity laser therapy, high power laser acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
This study will be conducted to answer the following question: Does high power laser acupuncture has any effect on pain, back range of motion, function, quality of life, fatigue and level of satisfaction in chronic nonspecific low back pain patients?
Detailed description
The aims of this study are:
- To investigate the effect of high power laser acupuncture on pain in chronic nonspecific low back pain patients
- To investigate the effect of high power laser acupuncture on back range of motion (flexion, extension, side bending and rotation) in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on function in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on quality of life in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on back muscle fatigue in chronic nonspecific low back pain patients.
- To investigate the effect of high power laser acupuncture on level of satisfaction in chronic nonspecific low back pain patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power laser acupuncture group | Experimental | Other: high power laser acupuncture (HPLA), Other: conventional treatmentThis group will receive high power laser acupuncture (HPLA) +conventional therapy |
| Conventional treatment group | Active comparator | Other: conventional treatment, Other: Sham laserThis group will receive sham laser and The first line of chronic nonspecific low back pain treatment is the conventional treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age over 18 years of age.
- Both genders (males and females).
- Normal BMI ranges between 18.5:24.9 kg/m2.
- 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.
- 6) CNSLBP patients will be diagnosed based on the standard criteria, including pain and tenderness on lower back and a negative result for all special tests for lumber neurological examination.
Key exclusion criteria (5 listed)
- History of any surgical procedure in the back or the lower extremities.
- Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
- Patient with lumbar instability including spondylolisthesis.
- Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
- 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 power laser acupuncture (HPLA)High power laser therapy A Zimmer Opton pro, integrated High-power class IV laser device (serial N: 15200013306 \& REF: 4682, made in Germany, manufactured by Zimmer Medizin System). It emits radiation in the infrared range to deliver topical heating and raise tissue temperature. The simultaneous application of two wavelengths of laser light (810 and 980nm) provides the user with a huge variety of therapy options. The laser probe - with the small spacer (3.1cm2) , with parameters of 3 watts, 5Hz, 50% duty cycle, 20 joule/ point for 13 seconds with 6.4 j/cm2 . Although a maximum power of 8000 W was reported in two studies, the average power of the lasers used in t | Other | High power laser acupuncture group |
| conventional treatmentSuperficial heat (hot packs). Will be applied 10 - 15 minutes. Guideline-endorsed treatment is to stay active, return to normal activity, and to exercise. Different exercise types are used in the treatment of CLBP such as strength and aerobic training on land as well as specific exercises such as motor control exercises (MCE). General exercises activating the extensor (paraspinals) and flexor (abdominals) muscle groups will be used. | Other | Conventional treatment group, High power laser acupuncture group |
| Sham lasersham laser (Not active) | Other | Conventional treatment group |
Primary outcome
Assessing the change in intensity of pain
Time frame: at baseline and after 4 weeks of intervention
By using visual analoge scale (VAS). It is a valid and reliable measure to assess pain intensity level by patients by making a mark determining a decimal number from 0 to 100 (mm) on line with 'no pain' to the left and severe pain could be to the right. The subjects will rate their perception of pain by making a mark on the VAS line. The distance from the left to the mark will be measured and the accuracy will be adjusted to one decimal place.
Assessing the change in Back Range of Motion
Time frame: at baseline and after 4 weeks of intervention
By using the Back Range of Motion Instrument (BROM). It is a valid and reliable measure to assess back range of motion (flexion, extension, side bending and rotation) The BROM is uses a patented inclinometer based instrument for measuring lateral side bend in the preferred upright position. The magnetic inclinometer and reference eliminate hip substitution errors. The BROM Basic includes two Universal Inclinometers for measuring flexion and extension of the lumbar spine.
Assessing the change in Quality of Life
Time frame: at baseline and after 4 weeks of intervention
By using the short version of the WHO Quality of Life Instrument in Arabic. It will be used to assess quality of life. The World Health Organization Quality-of-Life Scale (WHOQOL-BREF) provides a reliable, valid, and brief assessment of quality-of-life. There will be a four-domain score. The four domain scores will denote an individual perception of quality of life in each particular domain. Domains scores are scaled in a positive direction higher score denote higher quality of life. The mean score of items within each domain is used to calculate the domain score. Mean scores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
Assessing the change in endurance of the trunk extensor muscles
Time frame: at baseline and after 4 weeks of intervention
By using Biering-Sorensen test. The Sorensen test allows for a rapid, simple, and reproducible evaluation of the isometric endurance of the trunk extensor muscles. It discriminates between healthy individuals and patients with low back pain and may predict the occurrence of low back pain in the near future. The test consists in measuring the amount of time a person can hold the unsupported upper body in a horizontal prone position with the lower body fixed to the examining table. The Biering-Sørensen test for measuring back muscle fatigue is valid and provides reliable measures of position-holding time and can discriminate between subjects with and without nonspecific low back pain.
Assessing the change in patient satisfaction
Time frame: at baseline and after 4 weeks of intervention
By using The MedRisk Instrument for Measuring Patient Satisfaction (MRPS). A Self-report measures that sample a variety of items provide clinicians with an array of information that may assist in assessing patient satisfaction. The MRPS questionnaire is valid and reliable for measuring patient satisfaction. It has a 2-factor structure: "internal," relating to the patient-therapist interaction, and "external," describing no therapist issues such as admissions and clinic environment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Tasnim Mohamed principal investigator
Cairo University
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 power laser acupuncture (HPLA) and conventional treatment in people with 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Dec 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tasnim Mohamed (+20 106 800 3447, eth.com@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in intensity of pain (time frame: at baseline and after 4 weeks of intervention). The study lists 5 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 29 Dec 2023.