Low Back PainNCT06922981
Periodized Resistance and Aerobic Training in Non-Specific Chronic Low Back Pain
A study testing resistance training program in people with Low Back Pain, run by Cairo University at 2 sites in Egypt.
Trial summary
The aim of the study is to compare the effectiveness of two forms of periodized exercise training programs (resistance and aerobic ) using the best recommended parameters (volume, intensity, rest period, and frequency) on the best available outcome measures (pain, disability, fear of movement, back and abdominal… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- resistance training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Dec 2023to 25 Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants with nonspecific (nonspecific pathology) chronic (> 12 weeks) low back pain (localized below the costal margin and above the gluteal fold) (Owen et al., 2020).
- Participants aged between 18 to 45 years (Wewege et al., 2018).
- Participants with Body Mass Index (BMI) 18.5-29.9 Kg/m2.
- VAS score 3-8 cm (Pieler-Bruha, 2009).
- ODI score 10-60 (Pieler-Bruha, 2009).
Who cannot join
- Participants will be excluded if they did not meet the inclusion criteria mentioned above such as pain due to or associated with:
- Pregnancy
- Infection
- Fracture
- Tumor
- Structural deformity (e.g. scoliosis)
- Radicular syndrome or cauda equine syndrome
- Inflammatory disorders (Owen et al., 2020)
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy, Cairo Universi
Cairo, 12613
Faculty of Physical Therapy, Cairo Universi
Giza, 12613
About this study
Official title: Comparison Between Periodized Resistance and Aerobic Training Programs on Nonspecific Chronic Low Back Pain
The aim of the study is to compare the effectiveness of two forms of periodized exercise training programs (resistance and aerobic ) using the best recommended parameters (volume, intensity, rest period, and frequency) on the best available outcome measures (pain, disability, fear of movement, back and abdominal muscular endurance, upper body strength (latissimus dorsi muscle),and lower body strength ( gluteus maximus )
Read the detailed description
Low back pain (LBP) is a significant health problem and the leading cause of disability throughout the world, representing one of the most common reasons for primary care physician visits, with a lifetime prevalence reported as high as about 80%. It causes a significant economic and social burden that will become even more daunting in the coming decades. People with LBP are 2.5 times more likely to experience psychological distress and pain compared to normal people, which can adversely affect quality of life. Low back pain is commonly classified as nonspecific or specific due to the reported cause and as acute (<6weeks), subacute (6-12 weeks), or chronic (>12weeks) according to the duration of symptoms. A periodized training model is considered more effective at improving the physiological function than non-periodized (basic progressive overload), as it allows progressive adjustment of volume and intensity of training program.periodization is defined as the planned manipulation of training variables (load, sets, and repetitions) in order to maximize training adaptations and to prevent the onset of overtraining syndrome. Various periodization models exist: undulating periodization comprises a frequent variation in stimuli between low, moderate, and high intensity typically on a weekly basis, whereas traditional linear periodization typically contains low load and high volume in the initial phase of training with a gradual shift towards high load and low volume as the training progresses. Periodization may also be beneficial due to adding variation to workouts by manipulating sets, repetitions, exercise order, number of exercises, resistance, rest periods, type of contractions, or training frequency. Another added benefit is the avoidance of training plateaus or boredom. Thus it seems reasonable to consider a periodized training model in the management of those with NSCLBP.
- Conditions
- Low Back Pain
- Being tested
- resistance training program
- 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.
resistance training programBehavioural
Also called aerobic training program
Thirty-eight male and female patients aged 18-45 years, diagnosed with NSCLBP will be recruited through direct referrals from orthopedic surgeons, based on their availability to participate, thus a sample of convenience will be used, Participants will be randomly assigned as follows:
Group A:
Patients in group (A) (n=19) will receive a periodized resistance exercise program.
Group B:
The patients in group (B) (n=19) will receive a periodized aerobic exercise program
| Study group | Role | What they receive |
|---|---|---|
| resistance group | Experimental | Nineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The exercise program included upper and lower body resistance training exercises including leg press, lateral pull down, abdominal crunch, Swiss ball abdominal crunch, and prone superman exercises, utilizing free weights, machines, and bodyweight exercises. The therapist performed a one-repetition maximum (1 RM) test at baseline to determine the initial exercise loads. Participants then performed exercises at 50% to 70% of their 1 RM value. This process of periodic 1 RM testing and training at 50% to 70% of the value is repeated every two weeks till the end of the study. Receives: Behavioral: resistance training program |
| aerobic group | Experimental | Nineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The periodized aerobic training (AT) program consisted of three sessions per week. Each Exercise session consisted of a 5-minute warm-up, 30 minutes of aerobic exercise, and a 5-minute cool-down. Backward walking was performed on a motorized treadmill.The participants began with 10-15 minutes of exercise at 40-55% HRR (RPE=11-12, light) during the first two weeks, 20-30 minutes of exercise at 55-70% HRR (RPE=12-13, somewhat hard) during the third and fourth week, then 30 minutes of exercise at 70-85% HRR (RPE=14-16, hard) for the remainder of the study. Receives: Behavioral: resistance training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured by Visual Analogue Scale (VAS)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal scale where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain." Participants will rate their pain at rest and during movement.
Measured: baseline (week 0) and at the end of intervention (week 8)
Disability Level Measured by the Oswestry Disability Index (ODI)
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated 10-item questionnaire measuring limitations in daily activities due to pain. Each item is scored from 0 to 5, with total scores ranging from 0% (no disability) to 100% (severe disability). Higher scores indicate greater disability.
Measured: baseline (week 0) and at the end of intervention (week 8)
Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)
Fear of movement related to pain will be assessed using the Tampa Scale of Kinesiophobia (TSK), a validated 17-item questionnaire designed to measure fear of movement and injury-related avoidance behavior. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with total scores ranging from 17 (low fear) to 68 (high fear).
Measured: baseline (week 0) and at the end of intervention (week 8)
Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test
Abdominal endurance will be assessed using the Abdominal Muscular Endurance Test, which requires participants to perform a curl-up to the rhythm of a metronome for as long as possible.
Measured: baseline (week 0) and at the end of intervention (week 8)
Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test Back Isometric Muscular Endurance Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test (BSBE)
Back endurance will be assessed using the Biering-Sørensen Back Endurance Test (BSBE), which evaluates the endurance of the lumbar extensor muscles. The test involves the participant holding a prone position on a plinth with the upper body suspended and supported only by the pelvis and legs, maintaining this position for as long as possible.
Measured: baseline (week 0) and at the end of intervention (week 8)
Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer
Latissimus dorsi muscle strength will be assessed using a hand-held dynamometer. Participants will be instructed to perform a manual muscle contraction while the dynamometer is placed on the posterior surface of distal humerus. resistance was applied in the direction of shoulder flexion. The maximal force generated during the contraction will be recorded in newtons (N).
Measured: baseline (week 0) and at the end of intervention (week 8)
Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer
Gluteus maximus muscle strength will be assessed using a hand-held dynamometer. Participants will be asked to perform a hip extension against the dynamometer placed 5 c m proximal to the knee joint. The maximal force exerted during the movement will be recorded in newtons (N) to assess muscle strength.
Measured: baseline (week 0) and at the end of intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start25 Dec 2023
- Primary completion25 May 2024
- Study completion25 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saied mohammed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922981
- Sponsor's protocol ID
- periodized RT and AT in NSCLBP
- Status last verified
- Apr 2025
- First submitted
- 22 Dec 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cashin AG, Booth J, McAuley JH, Jones MD, Hubscher M, Traeger AC, Fried K, Moseley GL. Making exercise count: Considerations for the role of exercise in back pain treatment. Musculoskeletal Care. 2022 Jun;20(2):259-270. doi: 10.1002/msc.1597. Epub 2021 Oct 21.
PubMed 34676659Calatayud J, Guzman-Gonzalez B, Andersen LL, Cruz-Montecinos C, Morell MT, Roldan R, Ezzatvar Y, Casana J. Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8326. doi: 10.3390/ijerph17228326.
PubMed 33187076Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
PubMed 33922389Wewege MA, Booth J, Parmenter BJ. Aerobic vs. resistance exercise for chronic non-specific low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2018;31(5):889-899. doi: 10.3233/BMR-170920.
PubMed 29889056Lorenz D, Morrison S. CURRENT CONCEPTS IN PERIODIZATION OF STRENGTH AND CONDITIONING FOR THE SPORTS PHYSICAL THERAPIST. Int J Sports Phys Ther. 2015 Nov;10(6):734-47.
PubMed 26618056Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.
PubMed 32411374Mohammed AS, Youssef EF, Abdelnaeem AO. Periodized Resistance Training Versus Aerobic Training in Managing Nonspecific Chronic Low Back Pain: A Randomized Controlled Trial. Physiother Res Int. 2026 Oct;31(4):e70368. doi: 10.1002/pri.70368.
PubMed 42908089
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Periodized Resistance and Aerobic Training Programs on Nonspecific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06922981
- Acronym / sponsor ID
- periodized RT and AT in NSCLBP
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 25 Jun 2024 (actual)
- First posted
- 11 Apr 2025 (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 aim of the study is to compare the effectiveness of two forms of periodized exercise training programs (resistance and aerobic ) using the best recommended parameters (volume, intensity, rest period, and frequency) on the best available outcome measures (pain, disability, fear of movement, back and abdominal muscular endurance, upper body strength (latissimus dorsi muscle),and lower body strength ( gluteus maximus )
Detailed description
Low back pain (LBP) is a significant health problem and the leading cause of disability throughout the world, representing one of the most common reasons for primary care physician visits, with a lifetime prevalence reported as high as about 80%. It causes a significant economic and social burden that will become even more daunting in the coming decades. People with LBP are 2.5 times more likely to experience psychological distress and pain compared to normal people, which can adversely affect quality of life. Low back pain is commonly classified as nonspecific or specific due to the reported cause and as acute (<6weeks), subacute (6-12 weeks), or chronic (>12weeks) according to the duration of symptoms. A periodized training model is considered more effective at improving the physiological function than non-periodized (basic progressive overload), as it allows progressive adjustment of volume and intensity of training program.periodization is defined as the planned manipulation of training variables (load, sets, and repetitions) in order to maximize training adaptations and to prevent the onset of overtraining syndrome. Various periodization models exist: undulating periodization comprises a frequent variation in stimuli between low, moderate, and high intensity typically on a weekly basis, whereas traditional linear periodization typically contains low load and high volume in the initial phase of training with a gradual shift towards high load and low volume as the training progresses. Periodization may also be beneficial due to adding variation to workouts by manipulating sets, repetitions, exercise order, number of exercises, resistance, rest periods, type of contractions, or training frequency. Another added benefit is the avoidance of training plateaus or boredom. Thus it seems reasonable to consider a periodized training model in the management of those with NSCLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance group | Experimental | Behavioral: resistance training programNineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The exercise program included upper and lower body resistance training exercises including leg press, lateral pull down, abdominal crunch, Swiss ball abdominal crunch, and prone superman exercises, utilizing free weights, machines, and bodyweight exercises. The therapist performed a one-repetition maximum (1 RM) test at baseline to determine the initial exercise loads. Participants then performed exercises at 50% to 70% of their 1 RM value. This process of periodic 1 RM testing and training at 50% to 70% of the value is repeated every two weeks till the end of the study. |
| aerobic group | Experimental | Behavioral: resistance training programNineteen male and female patients aged 18 to 45 years, diagnosed with NSCLBP were recruited through referrals from orthopedic surgeons.The periodized aerobic training (AT) program consisted of three sessions per week. Each Exercise session consisted of a 5-minute warm-up, 30 minutes of aerobic exercise, and a 5-minute cool-down. Backward walking was performed on a motorized treadmill.The participants began with 10-15 minutes of exercise at 40-55% HRR (RPE=11-12, light) during the first two weeks, 20-30 minutes of exercise at 55-70% HRR (RPE=12-13, somewhat hard) during the third and fourth week, then 30 minutes of exercise at 70-85% HRR (RPE=14-16, hard) for the remainder of the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female participants with nonspecific (nonspecific pathology) chronic (> 12 weeks) low back pain (localized below the costal margin and above the gluteal fold) (Owen et al., 2020).
Key exclusion criteria (8 listed)
- Participants will be excluded if they did not meet the inclusion criteria mentioned above such as pain due to or associated with:
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 |
|---|---|---|
| resistance training programAlso: aerobic training programThirty-eight male and female patients aged 18-45 years, diagnosed with NSCLBP will be recruited through direct referrals from orthopedic surgeons, based on their availability to participate, thus a sample of convenience will be used, Participants will be randomly assigned as follows: Group A: Patients in group (A) (n=19) will receive a periodized resistance exercise program. Group B: The patients in group (B) (n=19) will receive a periodized aerobic exercise program | Behavioural | aerobic group, resistance group |
Primary outcome
Pain Intensity Measured by Visual Analogue Scale (VAS)
Time frame: baseline (week 0) and at the end of intervention (week 8)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 10 cm horizontal scale where 0 cm represents "no pain" and 10 cm represents "worst imaginable pain." Participants will rate their pain at rest and during movement.
Disability Level Measured by the Oswestry Disability Index (ODI)
Time frame: baseline (week 0) and at the end of intervention (week 8)
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a validated 10-item questionnaire measuring limitations in daily activities due to pain. Each item is scored from 0 to 5, with total scores ranging from 0% (no disability) to 100% (severe disability). Higher scores indicate greater disability.
Fear of movement measured by Tampa Scale of Kinesiophobia (TSK)
Time frame: baseline (week 0) and at the end of intervention (week 8)
Fear of movement related to pain will be assessed using the Tampa Scale of Kinesiophobia (TSK), a validated 17-item questionnaire designed to measure fear of movement and injury-related avoidance behavior. Each item is scored on a 4-point Likert scale (1 = strongly disagree to 4 = strongly agree), with total scores ranging from 17 (low fear) to 68 (high fear).
Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test Abdominal Muscular Endurance Measured by the Abdominal Muscular Endurance Test
Time frame: baseline (week 0) and at the end of intervention (week 8)
Abdominal endurance will be assessed using the Abdominal Muscular Endurance Test, which requires participants to perform a curl-up to the rhythm of a metronome for as long as possible.
Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test Back Isometric Muscular Endurance Back Isometric Muscular Endurance Measured by the Biering-Sørensen Back Endurance Test (BSBE)
Time frame: baseline (week 0) and at the end of intervention (week 8)
Back endurance will be assessed using the Biering-Sørensen Back Endurance Test (BSBE), which evaluates the endurance of the lumbar extensor muscles. The test involves the participant holding a prone position on a plinth with the upper body suspended and supported only by the pelvis and legs, maintaining this position for as long as possible.
Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer Latissimus Dorsi Muscle Strength Measured by Hand-Held Dynamometer
Time frame: baseline (week 0) and at the end of intervention (week 8)
Latissimus dorsi muscle strength will be assessed using a hand-held dynamometer. Participants will be instructed to perform a manual muscle contraction while the dynamometer is placed on the posterior surface of distal humerus. resistance was applied in the direction of shoulder flexion. The maximal force generated during the contraction will be recorded in newtons (N).
Gluteus Maximus Muscle Strength Measured by Hand-Held Dynamometer
Time frame: baseline (week 0) and at the end of intervention (week 8)
Gluteus maximus muscle strength will be assessed using a hand-held dynamometer. Participants will be asked to perform a hip extension against the dynamometer placed 5 c m proximal to the knee joint. The maximal force exerted during the movement will be recorded in newtons (N) to assess muscle strength.
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 11 Apr 2025.
- Results publication: PubMed 34676659Cashin AG, Booth J, McAuley JH, Jones MD, Hubscher M, Traeger AC, Fried K, Moseley GL. Making exercise count: Considerations for the role of exercise in back pain treatment. Musculoskeletal Care. 2022 Jun;20(2):259-270. doi: 10.1002/msc.1597. Epub 2021 Oct 21.
- Results publication: PubMed 33187076Calatayud J, Guzman-Gonzalez B, Andersen LL, Cruz-Montecinos C, Morell MT, Roldan R, Ezzatvar Y, Casana J. Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial. Int J Environ Res Public Health. 2020 Nov 11;17(22):8326. doi: 10.3390/ijerph17228326.
- Results publication: PubMed 33922389Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- Results publication: PubMed 29889056Wewege MA, Booth J, Parmenter BJ. Aerobic vs. resistance exercise for chronic non-specific low back pain: A systematic review and meta-analysis. J Back Musculoskelet Rehabil. 2018;31(5):889-899. doi: 10.3233/BMR-170920.
- Results publication: PubMed 26618056Lorenz D, Morrison S. CURRENT CONCEPTS IN PERIODIZATION OF STRENGTH AND CONDITIONING FOR THE SPORTS PHYSICAL THERAPIST. Int J Sports Phys Ther. 2015 Nov;10(6):734-47.
- Results publication: PubMed 32411374Tjosvoll SO, Mork PJ, Iversen VM, Rise MB, Fimland MS. Periodized resistance training for persistent non-specific low back pain: a mixed methods feasibility study. BMC Sports Sci Med Rehabil. 2020 May 8;12:30. doi: 10.1186/s13102-020-00181-0. eCollection 2020.
- Derived from this study: PubMed 42908089Mohammed AS, Youssef EF, Abdelnaeem AO. Periodized Resistance Training Versus Aerobic Training in Managing Nonspecific Chronic Low Back Pain: A Randomized Controlled Trial. Physiother Res Int. 2026 Oct;31(4):e70368. doi: 10.1002/pri.70368.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training program in people with Low Back Pain, run by Cairo University at 2 sites 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 8 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 11 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 2 sites 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?
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?
Pain Intensity Measured by Visual Analogue Scale (VAS) (time frame: baseline (week 0) and at the end of intervention (week 8)). The study lists 7 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 NCT06922981, which also lists 7 linked publications.
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 11 Apr 2025.