Muscle SorenessNCT04574661
Comparison of Intermittent Occlusion and Static Stretching
A study testing Static Stretching and Intermittent Occlusion in people with Muscle Soreness, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Static Stretching and Intermittent Occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2020to 30 Sep 2020
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age limit: 18 -25 years of age.
- Both Males and Females.
- Participants intending to join a fitness or body building program shortly ( the first exercise session would be utilized to induce mild muscle soreness )
- Participants ready for physical exertion according to PAR-Q.
Who cannot join
- Obesity (body mass index ≥ 30 kg/m2).
- Skeletal or Orthopedic Injuries.
- Known Cardiovascular disease.
- Open wounds.
- Uncontrolled Hypertension (resting brachial blood pressure ≥ 140/90 mmHg).
- Exercise induced muscle soreness in last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intermittent Occlusion and Static Stretching of Muscles in Prevention of Soreness and Vital Changes in Young Adults
To determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness
Read the detailed description
Main purpose of this study is to determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness. As muscle soreness is very major and basis problem of every individual , specially after enrolling into some physical activity .
First consent form will be given to both male and female participants from 18 to 25 years of age and after that PAR-Q Questionnaire will be filled for every individual, so that we will check their readiness for the Exercise then all the four Vitals will measured from every individual .They will randomly assigned by lottery method to intervention group and control group. Both group individuals will be exerted by Warm up for 5 mints, heel raise in 3 sets for 10 to 15 mints until we get 4 on RPE scale, by asking to hold dumbbells of 2 kg on both of the hands. Rate of perceived exertion (RPE) is calculated by Borg grading scale .Plus, leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS) will be measured for comparison within and between the groups. Again vitals will be monitored.
- Conditions
- Muscle Soreness
- Being tested
- Static Stretching, Intermittent Occlusion
- Keywords
- Muscle soreness, Vital Signs, Intermittent occlusion, Static stretching
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static StretchingOther
In Control group all the individuals will be asked to perform static stretching for 10 mints, 1 set . Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual.
Intermittent OcclusionOther
Individuals of Interventional group will be asked to lay down in supine position, apply proximal thigh cuff, 220mg for 12 minutes for intermittent occlusion. During this procedure discomfort will be checked on numeric pain rating scale, if we get 6 on scale, will stop the occlusion. Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual
| Study group | Role | What they receive |
|---|---|---|
| Static stretching | Active comparator | Static stretching to lower limb muscles Receives: Other: Static Stretching |
| Intermittent occlusion | Experimental | Intermittent occlusion to lower limb Receives: Other: Intermittent Occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric pain rating scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain. 27 Recent studies showed that the Majority of patients of all ages and both genders prefer NRS 28. Patients feel this scale of pain measuring technique quite easy and understandable. The benefit of the NRS is that it is validated as well as quick and easy to use.
Measured: 4th day
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint. This can be an indicator of stress which is unavoidable. Many studies showed that The universal goniometer are reliable in repeated measures of joint angles 30 .Manual goniometers can be used with confidence for longitudinal assessments in the clinic
Measured: 4th day
Measuring Tape
Tape measurement has been used for decades round measurement or the contour of the Muscle to detect atrophy or hypertrophy of Joint to determine swelling. Research shows that measuring tape is valid and reliable tool for circumference measurements .Circumference measurements taken by spring tape have high reliability
Measured: 4th day
Borg Rate of Perceived Exertion
Research suggest that the Borg CR-10 scale is valid and reliable for monitoring exercise intensity
Measured: 4th day
PAR-Q Questionnaire
Physical Activity Readiness Questionnaire (PARQ) clearance has been recommended prior to low-to-moderate exercise involvement. Physical Activity Readiness Questionnaire (PARQ) is safe and effective means of risk stratification for patients interested in becoming more physically active. These results support the concurrent validity of the PARQ and suggest the revisions have had their intended effect
Measured: 4th day
Temperature
A valid Tool for temperature measurement which has been in use from centuries is Mercury Thermometer.
Measured: 4th day
Pulse rate
The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute which can be felt by the beats by firmly pressing on the arteries, which are located close to the surface of the skin at certain points of the body. In this study we will be using Radial Artery.
Measured: 4th day
Respiratory Rate
The respiration rate is the number of breaths a person takes per minute , when a person is at rest counting the number of breaths for one minute by counting how many times the chest rises.
Measured: 4th day
Blood pressure
The aneroid monitor is valid and cost effective tool which for measuring blood pressure
Measured: 4th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start15 Jan 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Aftab, Phd*, Principal investigator, Riphah college of rehabilitation and allied health sciences - Rawalpindi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574661
- Sponsor's protocol ID
- REC/00240 Urooj Fatima
- Status last verified
- Feb 2021
- First submitted
- 16 Sep 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magoffin RD, Parcell AC, Hyldahl RD, Fellingham GW, Hopkins JT, Feland JB. Whole-Body Vibration as a Warm-up Before Exercise-Induced Muscle Damage on Symptoms of Delayed-Onset Muscle Soreness in Trained Subjects. J Strength Cond Res. 2020 Apr;34(4):1123-1132. doi: 10.1519/JSC.0000000000002896.
PubMed 30399118Brandner CR, Warmington SA. Delayed Onset Muscle Soreness and Perceived Exertion After Blood Flow Restriction Exercise. J Strength Cond Res. 2017 Nov;31(11):3101-3108. doi: 10.1519/JSC.0000000000001779.
PubMed 28118308Hedayatpour N, Arendt-Nielsen L, Falla D. Facilitation of quadriceps activation is impaired following eccentric exercise. Scand J Med Sci Sports. 2014 Apr;24(2):355-62. doi: 10.1111/j.1600-0838.2012.01512.x. Epub 2012 Aug 12.
PubMed 22882137Kanda K, Sugama K, Hayashida H, Sakuma J, Kawakami Y, Miura S, Yoshioka H, Mori Y, Suzuki K. Eccentric exercise-induced delayed-onset muscle soreness and changes in markers of muscle damage and inflammation. Exerc Immunol Rev. 2013;19:72-85.
PubMed 23977721Dupuy O, Douzi W, Theurot D, Bosquet L, Dugue B. An Evidence-Based Approach for Choosing Post-exercise Recovery Techniques to Reduce Markers of Muscle Damage, Soreness, Fatigue, and Inflammation: A Systematic Review With Meta-Analysis. Front Physiol. 2018 Apr 26;9:403. doi: 10.3389/fphys.2018.00403. eCollection 2018.
PubMed 29755363Newton MJ, Morgan GT, Sacco P, Chapman DW, Nosaka K. Comparison of responses to strenuous eccentric exercise of the elbow flexors between resistance-trained and untrained men. J Strength Cond Res. 2008 Mar;22(2):597-607. doi: 10.1519/JSC.0b013e3181660003.
PubMed 18550979Graven-Nielsen T, Arendt-Nielsen L. Induction and assessment of muscle pain, referred pain, and muscular hyperalgesia. Curr Pain Headache Rep. 2003 Dec;7(6):443-51. doi: 10.1007/s11916-003-0060-y.
PubMed 14604503Chapman D, Newton M, Sacco P, Nosaka K. Greater muscle damage induced by fast versus slow velocity eccentric exercise. Int J Sports Med. 2006 Aug;27(8):591-8. doi: 10.1055/s-2005-865920.
PubMed 16874584Costello JT, Baker PR, Minett GM, Bieuzen F, Stewart IB, Bleakley C. Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Cochrane Database Syst Rev. 2015 Sep 18;2015(9):CD010789. doi: 10.1002/14651858.CD010789.pub2.
PubMed 26383887Luetmer MT, Do A, Canzanello NC, Bauer BA, Laskowski ER. The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population. Am J Phys Med Rehabil. 2019 Nov;98(11):964-970. doi: 10.1097/PHM.0000000000001226.
PubMed 31135462Farias Junior LF, Browne RAV, Frazao DT, Dantas TCB, Silva PHM, Freitas RPA, Aoki MS, Costa EC. Effect of Low-Volume High-Intensity Interval Exercise and Continuous Exercise on Delayed-Onset Muscle Soreness in Untrained Healthy Males. J Strength Cond Res. 2019 Mar;33(3):774-782. doi: 10.1519/JSC.0000000000002059.
PubMed 28614163Beaven CM, Cook CJ, Kilduff L, Drawer S, Gill N. Intermittent lower-limb occlusion enhances recovery after strenuous exercise. Appl Physiol Nutr Metab. 2012 Dec;37(6):1132-9. doi: 10.1139/h2012-101. Epub 2012 Sep 12.
PubMed 22970789Page W, Swan R, Patterson SD. The effect of intermittent lower limb occlusion on recovery following exercise-induced muscle damage: A randomized controlled trial. J Sci Med Sport. 2017 Aug;20(8):729-733. doi: 10.1016/j.jsams.2016.11.015. Epub 2017 Jan 24.
PubMed 28153608LaRoche DP, Connolly DA. Effects of stretching on passive muscle tension and response to eccentric exercise. Am J Sports Med. 2006 Jun;34(6):1000-7. doi: 10.1177/0363546505284238. Epub 2006 Feb 13.
PubMed 16476913Cheung K, Hume P, Maxwell L. Delayed onset muscle soreness : treatment strategies and performance factors. Sports Med. 2003;33(2):145-64. doi: 10.2165/00007256-200333020-00005.
PubMed 12617692
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intermittent Occlusion and Static Stretching of Muscles in Prevention of Soreness and Vital Changes in Young Adults
- ClinicalTrials.gov ID
- NCT04574661
- Acronym / sponsor ID
- REC/00240 Urooj Fatima
- Conditions
- Muscle Soreness
- Keywords
- Muscle soreness, Vital Signs, Intermittent occlusion, Static stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 5 Oct 2020 (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 determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness
Detailed description
Main purpose of this study is to determine changes in Vitals caused by Intermittent Occlusion ( 220 mg ) and to compare the effectiveness of Intermittent Occlusion and Static Stretching of the lower limb muscle group in preventing the development of exercise induce Muscle Soreness. As muscle soreness is very major and basis problem of every individual , specially after enrolling into some physical activity .
First consent form will be given to both male and female participants from 18 to 25 years of age and after that PAR-Q Questionnaire will be filled for every individual, so that we will check their readiness for the Exercise then all the four Vitals will measured from every individual .They will randomly assigned by lottery method to intervention group and control group. Both group individuals will be exerted by Warm up for 5 mints, heel raise in 3 sets for 10 to 15 mints until we get 4 on RPE scale, by asking to hold dumbbells of 2 kg on both of the hands. Rate of perceived exertion (RPE) is calculated by Borg grading scale .Plus, leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS) will be measured for comparison within and between the groups. Again vitals will be monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static stretching | Active comparator | Other: Static StretchingStatic stretching to lower limb muscles |
| Intermittent occlusion | Experimental | Other: Intermittent OcclusionIntermittent occlusion to lower limb |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age limit: 18 -25 years of age.
- Both Males and Females.
- Participants intending to join a fitness or body building program shortly ( the first exercise session would be utilized to induce mild muscle soreness )
- Participants ready for physical exertion according to PAR-Q.
Key exclusion criteria (6 listed)
- Obesity (body mass index ≥ 30 kg/m2).
- Skeletal or Orthopedic Injuries.
- Known Cardiovascular disease.
- Open wounds.
- Uncontrolled Hypertension (resting brachial blood pressure ≥ 140/90 mmHg).
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 |
|---|---|---|
| Static StretchingIn Control group all the individuals will be asked to perform static stretching for 10 mints, 1 set . Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual. | Other | Static stretching |
| Intermittent OcclusionIndividuals of Interventional group will be asked to lay down in supine position, apply proximal thigh cuff, 220mg for 12 minutes for intermittent occlusion. During this procedure discomfort will be checked on numeric pain rating scale, if we get 6 on scale, will stop the occlusion. Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual | Other | Intermittent occlusion |
Primary outcome
Numeric pain rating scale (NPRS)
Time frame: 4th day
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It has been shown that a composite scoring system including best, worse, and current level of pain. 27 Recent studies showed that the Majority of patients of all ages and both genders prefer NRS 28. Patients feel this scale of pain measuring technique quite easy and understandable. The benefit of the NRS is that it is validated as well as quick and easy to use.
Goniometer
Time frame: 4th day
A goniometer is an instrument which measures the available range of motion at a joint. This can be an indicator of stress which is unavoidable. Many studies showed that The universal goniometer are reliable in repeated measures of joint angles 30 .Manual goniometers can be used with confidence for longitudinal assessments in the clinic
Measuring Tape
Time frame: 4th day
Tape measurement has been used for decades round measurement or the contour of the Muscle to detect atrophy or hypertrophy of Joint to determine swelling. Research shows that measuring tape is valid and reliable tool for circumference measurements .Circumference measurements taken by spring tape have high reliability
Borg Rate of Perceived Exertion
Time frame: 4th day
Research suggest that the Borg CR-10 scale is valid and reliable for monitoring exercise intensity
PAR-Q Questionnaire
Time frame: 4th day
Physical Activity Readiness Questionnaire (PARQ) clearance has been recommended prior to low-to-moderate exercise involvement. Physical Activity Readiness Questionnaire (PARQ) is safe and effective means of risk stratification for patients interested in becoming more physically active. These results support the concurrent validity of the PARQ and suggest the revisions have had their intended effect
Temperature
Time frame: 4th day
A valid Tool for temperature measurement which has been in use from centuries is Mercury Thermometer.
Pulse rate
Time frame: 4th day
The pulse rate is a measurement of the heart rate, or the number of times the heart beats per minute which can be felt by the beats by firmly pressing on the arteries, which are located close to the surface of the skin at certain points of the body. In this study we will be using Radial Artery.
Respiratory Rate
Time frame: 4th day
The respiration rate is the number of breaths a person takes per minute , when a person is at rest counting the number of breaths for one minute by counting how many times the chest rises.
Blood pressure
Time frame: 4th day
The aneroid monitor is valid and cost effective tool which for measuring blood pressure
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 17 Feb 2021.
- Background: PubMed 30399118Magoffin RD, Parcell AC, Hyldahl RD, Fellingham GW, Hopkins JT, Feland JB. Whole-Body Vibration as a Warm-up Before Exercise-Induced Muscle Damage on Symptoms of Delayed-Onset Muscle Soreness in Trained Subjects. J Strength Cond Res. 2020 Apr;34(4):1123-1132. doi: 10.1519/JSC.0000000000002896.
- Background: PubMed 28118308Brandner CR, Warmington SA. Delayed Onset Muscle Soreness and Perceived Exertion After Blood Flow Restriction Exercise. J Strength Cond Res. 2017 Nov;31(11):3101-3108. doi: 10.1519/JSC.0000000000001779.
- Background: PubMed 22882137Hedayatpour N, Arendt-Nielsen L, Falla D. Facilitation of quadriceps activation is impaired following eccentric exercise. Scand J Med Sci Sports. 2014 Apr;24(2):355-62. doi: 10.1111/j.1600-0838.2012.01512.x. Epub 2012 Aug 12.
- Background: PubMed 23977721Kanda K, Sugama K, Hayashida H, Sakuma J, Kawakami Y, Miura S, Yoshioka H, Mori Y, Suzuki K. Eccentric exercise-induced delayed-onset muscle soreness and changes in markers of muscle damage and inflammation. Exerc Immunol Rev. 2013;19:72-85.
- Background: PubMed 29755363Dupuy O, Douzi W, Theurot D, Bosquet L, Dugue B. An Evidence-Based Approach for Choosing Post-exercise Recovery Techniques to Reduce Markers of Muscle Damage, Soreness, Fatigue, and Inflammation: A Systematic Review With Meta-Analysis. Front Physiol. 2018 Apr 26;9:403. doi: 10.3389/fphys.2018.00403. eCollection 2018.
- Background: PubMed 18550979Newton MJ, Morgan GT, Sacco P, Chapman DW, Nosaka K. Comparison of responses to strenuous eccentric exercise of the elbow flexors between resistance-trained and untrained men. J Strength Cond Res. 2008 Mar;22(2):597-607. doi: 10.1519/JSC.0b013e3181660003.
- Background: PubMed 14604503Graven-Nielsen T, Arendt-Nielsen L. Induction and assessment of muscle pain, referred pain, and muscular hyperalgesia. Curr Pain Headache Rep. 2003 Dec;7(6):443-51. doi: 10.1007/s11916-003-0060-y.
- Background: PubMed 16874584Chapman D, Newton M, Sacco P, Nosaka K. Greater muscle damage induced by fast versus slow velocity eccentric exercise. Int J Sports Med. 2006 Aug;27(8):591-8. doi: 10.1055/s-2005-865920.
- Background: PubMed 26383887Costello JT, Baker PR, Minett GM, Bieuzen F, Stewart IB, Bleakley C. Whole-body cryotherapy (extreme cold air exposure) for preventing and treating muscle soreness after exercise in adults. Cochrane Database Syst Rev. 2015 Sep 18;2015(9):CD010789. doi: 10.1002/14651858.CD010789.pub2.
- Background: PubMed 31135462Luetmer MT, Do A, Canzanello NC, Bauer BA, Laskowski ER. The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population. Am J Phys Med Rehabil. 2019 Nov;98(11):964-970. doi: 10.1097/PHM.0000000000001226.
- Background: PubMed 28614163Farias Junior LF, Browne RAV, Frazao DT, Dantas TCB, Silva PHM, Freitas RPA, Aoki MS, Costa EC. Effect of Low-Volume High-Intensity Interval Exercise and Continuous Exercise on Delayed-Onset Muscle Soreness in Untrained Healthy Males. J Strength Cond Res. 2019 Mar;33(3):774-782. doi: 10.1519/JSC.0000000000002059.
- Background: PubMed 22970789Beaven CM, Cook CJ, Kilduff L, Drawer S, Gill N. Intermittent lower-limb occlusion enhances recovery after strenuous exercise. Appl Physiol Nutr Metab. 2012 Dec;37(6):1132-9. doi: 10.1139/h2012-101. Epub 2012 Sep 12.
- Individual participant dataSharing planned: No
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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.
Anam Aftab, Phd* principal investigator
Riphah college of rehabilitation and allied health sciences - Rawalpindi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Stretching and Intermittent Occlusion in people with Muscle Soreness, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 6 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 17 Feb 2021. 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 Pakistan. 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?
Numeric pain rating scale (NPRS) (time frame: 4th day). The study lists 9 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 NCT04574661, which also lists 16 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 17 Feb 2021.