Low Back PainNCT06586450
Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain
A study testing Low level laser therapy, Interferential current and Core stability exercise in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Low level laser therapy, Interferential current and Core stability exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 15 Jan 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty postmenopausal women (at least one year after stoppage menses).
- Their age will be ranged from 50 to 60 years.
- Their body mass index (BMI) will be less than 30 kg/m2.
- All of them suffer from chronic low back pain (at least 3 months).
- The score of pain will be 2 or more according to visual analogue scale (VAS).
Who cannot join
- Spinal fracture or any other neurological disorder.
- Lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
- BMI>30 kg/m2
- Gynecological Diseases as Chronic pelvic pain or genital prolapse.
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain.
Read the detailed description
Low back pain (LBP) is a major health problem affecting majority of the people at some point of their life.The prevalence of postmenopausal LBP is 32.4%. It has major implication for quality of life, such as limitation of daily activities and physiological stress, being one of the main causes of work absenteeism.
The prolonged use of NSAIDs is associated with cardiovascular, hepatic, and renal problems. Therefore, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy to relieve postmenopausal LBP.
Low level laser has been proven to have an impact on postmenopausal LBP, through several mechanisms as (a) increased endogenous opioid neurotransmitter production ;(b)raised threshold to thermal pain and enhanced local blood circulation ; (c)increased oxygen consumption by accelerating the redox reaction rate of the electron respiratory chain of mitochondria ; (d) increased adenosine triphosphate (ATP) production at the cellular level ;(e) increased production of the anti-inflammatory cytokines.
Also, another non- invasive technique is the interferential current which is one of the existing electrotherapy treatments used to reduce pain and has been studied for its effectiveness in relieving LBP through its deeper penetration into the tissues.
So, this study will be conducted to provide new evidence and information about the efficacy of low-level laser versus interferential current on LBP in postmenopausal women
- Conditions
- Low Back Pain
- Being tested
- Low level laser therapy, Interferential current, Core stability exercise
- 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.
Low level laser therapyDevice
The participants will receive Low Level Laser on lumbo-pelvic region for 20 min/sessions,3 sessions / week for 12 weeks, with the following parameters: Wavelength: 808 nm, continuous mode, Output power: 160 mw, Penetration depth: 4 cm, Power density:0.16 J/cm2.
Interferential currentDevice
All participants will receive interferential current on lumbopelvic region ( quadripolar technique) for 25 min/session, 3 sessions/week for 12 weeks, with the following parameters: carrier frequency of 4 KHZ and sweep frequency 95 HZ, intensity based on patient's tolerance without muscle contraction.
Core stability exerciseOther
The participants will perform core stability exercises for 15 min 3 time/week in the form of Prone Gluteal Squeezes, Pelvic Bridging, Curl Up Exercise, and Double Knee to Chest Stretching Exercises.
| Study group | Role | What they receive |
|---|---|---|
| Low level laser group | Experimental | The participants will receive low level laser therapy and core stability exercises Receives: Device: Low level laser therapy; Other: Core stability exercise |
| Interferential current group | Experimental | The participants will receive interferential current and core stability exercises Receives: Device: Interferential current; Other: Core stability exercise |
| Core stability exercise group | Active comparator | The participants will perform core stability exercises only Receives: Other: Core stability exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
Measured: 12 weeks
Lumbar flexion range of motion
The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).
Measured: 12 weeks
Lumbar extension range of motion
The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1cm should be considered abnormal).
Measured: 12 weeks
Lumbar lateral flexion range of motion
The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.
Measured: 12 weeks
Secondary outcomes (1)
Functional disability
Functional disability will be assessed by the Oswestry Disability Index, it was developed as a clinical valid and reliable assessment tool that would provide an estimate of disability expressed as a percentage score. It is composed of 10 questions and it takes around 5min for a patient to complete. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0-20, minimal disability; 21-40, moderate disability; 41-60, severe disability; 61-80, crippling back pain; 81-100, bed-bound. A low score = low degree of disability, a high score = high degree of disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2024 (estimated)
- Primary completion10 Dec 2024 (estimated)
- Study completion15 Jan 2025 (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, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Saad Ibrahim El-Naggar, Cairo University
- Investigators
- Azza B Kassab, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586450
- Sponsor's protocol ID
- P.T.REC/012/005317
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Versus Interferential Current on Postmenopausal Low Back Pain
- ClinicalTrials.gov ID
- NCT06586450
- Acronym / sponsor ID
- P.T.REC/012/005317
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (estimated)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 19 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.
This study will be conducted to compare the effect of low-level laser and interferential current on postmenopausal low back pain.
Detailed description
Low back pain (LBP) is a major health problem affecting majority of the people at some point of their life.The prevalence of postmenopausal LBP is 32.4%. It has major implication for quality of life, such as limitation of daily activities and physiological stress, being one of the main causes of work absenteeism.
The prolonged use of NSAIDs is associated with cardiovascular, hepatic, and renal problems. Therefore, there is a need for emphasis on alternative methods of conservative treatment as non-pharmacological and non-invasive therapy to relieve postmenopausal LBP.
Low level laser has been proven to have an impact on postmenopausal LBP, through several mechanisms as (a) increased endogenous opioid neurotransmitter production ;(b)raised threshold to thermal pain and enhanced local blood circulation ; (c)increased oxygen consumption by accelerating the redox reaction rate of the electron respiratory chain of mitochondria ; (d) increased adenosine triphosphate (ATP) production at the cellular level ;(e) increased production of the anti-inflammatory cytokines.
Also, another non- invasive technique is the interferential current which is one of the existing electrotherapy treatments used to reduce pain and has been studied for its effectiveness in relieving LBP through its deeper penetration into the tissues.
So, this study will be conducted to provide new evidence and information about the efficacy of low-level laser versus interferential current on LBP in postmenopausal women
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level laser group | Experimental | Device: Low level laser therapy, Other: Core stability exerciseThe participants will receive low level laser therapy and core stability exercises |
| Interferential current group | Experimental | Device: Interferential current, Other: Core stability exerciseThe participants will receive interferential current and core stability exercises |
| Core stability exercise group | Active comparator | Other: Core stability exerciseThe participants will perform core stability exercises only |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Sixty postmenopausal women (at least one year after stoppage menses).
- Their age will be ranged from 50 to 60 years.
- Their body mass index (BMI) will be less than 30 kg/m2.
- All of them suffer from chronic low back pain (at least 3 months).
- The score of pain will be 2 or more according to visual analogue scale (VAS).
Key exclusion criteria (4 listed)
- Spinal fracture or any other neurological disorder.
- Lumbar disc herniation, degenerative joint diseases, or spondylolisthesis.
- BMI>30 kg/m2
- Gynecological Diseases as Chronic pelvic pain or genital prolapse.
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 |
|---|---|---|
| Low level laser therapyThe participants will receive Low Level Laser on lumbo-pelvic region for 20 min/sessions,3 sessions / week for 12 weeks, with the following parameters: Wavelength: 808 nm, continuous mode, Output power: 160 mw, Penetration depth: 4 cm, Power density:0.16 J/cm2. | Device | Low level laser group |
| Interferential currentAll participants will receive interferential current on lumbopelvic region ( quadripolar technique) for 25 min/session, 3 sessions/week for 12 weeks, with the following parameters: carrier frequency of 4 KHZ and sweep frequency 95 HZ, intensity based on patient's tolerance without muscle contraction. | Device | Interferential current group |
| Core stability exerciseThe participants will perform core stability exercises for 15 min 3 time/week in the form of Prone Gluteal Squeezes, Pelvic Bridging, Curl Up Exercise, and Double Knee to Chest Stretching Exercises. | Other | Core stability exercise group, Interferential current group, Low level laser group |
Primary outcome
Pain severity
Time frame: 12 weeks
The intensity of postmenopausal low back pain will be assessed using a visual analogue scale (VAS) for all participants in the three groups before and after treatment, which is a method of representing subjects' pain on a 10 cm linear scale. A score of 0 means " no pain" and 10 means " very high degree of pain
Lumbar flexion range of motion
Time frame: 12 weeks
The modified Schober test will be used to measure the lumbar flexion range of motion (ROM) by using the tape measurement. Each participant will be asked to stand erect with her feet about shoulder-width apart to stabilize the pelvis. Then, the posterior superior iliac spines(PSIS) will be determined by the therapist's both thumbs, and then an ink line will be drawn along the midline of the lumbar spines horizontal to the PSIS to mark the midpoint between the two PSIS. Then tape will be used to identify and mark two points: one is 10 cm superior to the midpoint (A), and another is 5 cm inferior to the midpoint (B). The participant will be instructed to bend forward as much as she can while keeping both knees straight, the new distance between superior and inferior skin marking will be measured in centimeters. The increased distance along the tape due to lumbar flexion is normally about 6-7 cm (less than 5 cm should be considered abnormal).
Lumbar extension range of motion
Time frame: 12 weeks
The modified Schober test will be used to measure the lumbar extension range of motion (ROM) by using the tape measurement while the patient is in a standing position. The participant will be instructed to put her hands on her buttocks and bend backward into full lumbar extension and the new distance between the superior and inferior skin markings will be measured in centimeters by the tape measurement. The change in the difference between the marks is used to indicate the amount of lumbar extension. The increased distance along the tape due to the extension of the lumbar spine is normally about 2-3 cm (less than 1cm should be considered abnormal).
Lumbar lateral flexion range of motion
Time frame: 12 weeks
The participant will be asked to stand erect with her feet about shoulder-width apart. Both right and left lateral flexion will be measured by the tape as the distance from the tip of the index finger to the floor at maximal comfortable lateral flexion. The participant will be instructed to bend her trunk laterally as much as she can. The normal value of lateral spinal flexion is 16.2-28.0 cm.
1 secondary outcome
Functional disability
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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.
Azza B Kassab, professor study chair
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 Low level laser therapy, Interferential current and Core stability exercise 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 5 inclusion and 4 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 19 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. 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 Ola S El-Naggar, Master (+201022105583, olaelnaggar2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity (time frame: 12 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 19 Sep 2024.