Muscle SorenessNCT04182295
Does Placebo Information Affect the Trial Outcomes and Participant Blinding?
A study testing acupuncture in people with Muscle Soreness, run by Kyunghee University at 1 site in South Korea.
Trial summary
This is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2019to 20 Dec 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 18
- not participating in other studies at the time of study participation
- voluntary participation
Who cannot join
- resistance training for more than 6 months
- experience of fracture of any of four limbs
- pregnancy or breast-feeding at the time of study participation
- analgesics within 24 hours before participation
- any other diseases or conditions that might prevent the participant from receiving acupuncture
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Acupuncture & Meridian Science Research Centre
Seoul, 02447
About this study
Official title: Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding
This is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial.
Read the detailed description
A total of 89 healthy volunteers will be recruited and randomly allocated to one of the 4 groups at an identical ratio. Four groups differ in acupuncture and placebo information. It is summarized as follows:
- to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent
- to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent
- to receive sham acupuncture (Park Sham Needle) and to read fully disclosed sham acupuncture information written in the informed consent
- to receive sham acupuncture to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent.
They will read informed consent with differently described placebo information following their allocation. After participants repeatedly lift a dumbbell with their non-dominant arm to induce delayed onset muscle soreness (DOMS) in their biceps brachii, they are given allocated acupuncture treatment once a day for three consecutive days including the very first visit to compare outcomes (i.e., relief of DOMS measured with pressure pain threshold and visual analogue scale) and blinding property (the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know options).
- Conditions
- Muscle Soreness
- Being tested
- acupuncture, Park Sham Needle
- Keywords
- Placebo, Informed consent, Participant information leaflet, Outcome, Blinding, Sham, Acupuncture, Delayed Onset Muscle Soreness
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureDevice
A sterilised stainless steel needle (diameter 0.25mm X length 40mm, Dongbang Acupuncture Inc., Boryeong, Chungchenongnam-do, Korea) will be given at PC3, LI4, LI11, and LU5 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).
Park Sham NeedleDevice
Also called sham acupuncture
A Park Sham Needle (Meridius Medical Ltd. \& DongBang Acuprime Ltd., Exeter, UK), non-penetrating sham acupuncture, will be given at two points on the belly of biceps brachii, 1 cun proximedially from LI11, and 1 cun laterally from PC3 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).
| Study group | Role | What they receive |
|---|---|---|
| real acupuncture-full disclosure | Experimental | Participants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture). Receives: Device: acupuncture |
| real acupuncture-partial disclosure | Experimental | Participants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture). Receives: Device: acupuncture |
| sham acupuncture-full disclosure | Sham comparator | Participants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture). Receives: Device: Park Sham Needle |
| sham acupuncture-partial disclosure | Sham comparator | Participants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture). Receives: Device: Park Sham Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)
Muscle discomfort of DOMS induced arm is evaluated with VAS ranging from 0 to 10 cm (with 0 indicating no discomfort and 10 experiencing the worst imaginable muscle discomfort.)
Measured: day 0; day 1; day 2
Blinding property
Blinding property is evaluated: participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of experimental group, control group, and do not know. It is calculated following the way of Bang's Blind Index; -1 indicates opposite guessing; 0 indicates random guessing; 1 indicates correct guessing.
Measured: day 2
the change in Pressure Pain Threshold (PPT) from baseline, i.e., before being induced DOMS
Pressure Pain Threshold (PPT) will be evaluated on the 5 points of upper non-dominant arm. Five points are selected from 6 equidistance from origin to insertion of biceps brachii with an exception of the first and last point, perpendicular to the belly of the biceps brachii. Pressure was applied to each of these points with increasing force at a rate of approximately 10 N/cm2*sec until the participant reported a painful sensation, and the force value was recorded (N/cm2). An upper limit of PPt was set 50 N/cm2 to avoid bruising.
Measured: day 0; day 1; day 2
Secondary outcomes (1)
Acupuncture sensation measured by De-qi questionnaire
De-qi questionnaire (Kim et al.) is used to evaluate acupuncture sensation measured in VAS ranging from 0 to 10 cm (with 0 indicating no feeling of respective 18 items included in the questionnaire and 10 experiencing the worst imaginable feeling of respective 18 items included in the questionnaire.)
Measured: day 0; day 1; day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start7 Oct 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
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.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Hyangsook Lee, KMD, PhD, Kyunghee University
- Investigators
- Hyangsook Lee, Doctor, Principal investigator, Kyunghee University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182295
- Sponsor's protocol ID
- KHSIRB-19-173
- Status last verified
- Sep 2020
- First submitted
- 25 Nov 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
PubMed 15020033Bishop FL, Adams AE, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One. 2012;7(6):e39661. doi: 10.1371/journal.pone.0039661. Epub 2012 Jun 27.
PubMed 22761859Cheon S, Park HJ, Chae Y, Lee H. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture. BMC Med Res Methodol. 2018 Jan 18;18(1):13. doi: 10.1186/s12874-018-0474-1.
PubMed 29347917Gillon R. Ethics needs principles--four can encompass the rest--and respect for autonomy should be "first among equals". J Med Ethics. 2003 Oct;29(5):307-12. doi: 10.1136/jme.29.5.307.
PubMed 14519842Harris J. In praise of unprincipled ethics. J Med Ethics. 2003 Oct;29(5):303-6. doi: 10.1136/jme.29.5.303.
PubMed 14519841Corder KE, Newsham KR, McDaniel JL, Ezekiel UR, Weiss EP. Effects of Short-Term Docosahexaenoic Acid Supplementation on Markers of Inflammation after Eccentric Strength Exercise in Women. J Sports Sci Med. 2016 Feb 23;15(1):176-83. eCollection 2016 Mar.
PubMed 26957941Dennehy EB, Webb A, Suppes T. Assessment of beliefs in the effectiveness of acupuncture for treatment of psychiatric symptoms. J Altern Complement Med. 2002 Aug;8(4):421-5. doi: 10.1089/107555302760253612.
PubMed 12230902Fleckenstein J, Niederer D, Auerbach K, Bernhorster M, Hubscher M, Vogt L, Banzer W. No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. Clin J Sport Med. 2016 Nov;26(6):471-477. doi: 10.1097/JSM.0000000000000259.
PubMed 26540600Fleckenstein J, Simon P, Konig M, Vogt L, Banzer W. The pain threshold of high-threshold mechanosensitive receptors subsequent to maximal eccentric exercise is a potential marker in the prediction of DOMS associated impairment. PLoS One. 2017 Oct 6;12(10):e0185463. doi: 10.1371/journal.pone.0185463. eCollection 2017.
PubMed 28985238Graves JE, Pollock ML, Leggett SH, Braith RW, Carpenter DM, Bishop LE. Effect of reduced training frequency on muscular strength. Int J Sports Med. 1988 Oct;9(5):316-9. doi: 10.1055/s-2007-1025031.
PubMed 3246465Hubscher M, Vogt L, Bernhorster M, Rosenhagen A, Banzer W. Effects of acupuncture on symptoms and muscle function in delayed-onset muscle soreness. J Altern Complement Med. 2008 Oct;14(8):1011-6. doi: 10.1089/acm.2008.0173.
PubMed 18990049Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
PubMed 24401940Lin MJ, Nosaka K, Ho CC, Chen HL, Tseng KW, Ratel S, Chen TC. Influence of Maturation Status on Eccentric Exercise-Induced Muscle Damage and the Repeated Bout Effect in Females. Front Physiol. 2018 Jan 5;8:1118. doi: 10.3389/fphys.2017.01118. eCollection 2017.
PubMed 29354073Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther. 1987 Sep;42(3):250-3. doi: 10.1038/clpt.1987.142.
PubMed 3621780Shimano T, Kraemer WJ, Spiering BA, Volek JS, Hatfield DL, Silvestre R, Vingren JL, Fragala MS, Maresh CM, Fleck SJ, Newton RU, Spreuwenberg LP, Hakkinen K. Relationship between the number of repetitions and selected percentages of one repetition maximum in free weight exercises in trained and untrained men. J Strength Cond Res. 2006 Nov;20(4):819-23. doi: 10.1519/R-18195.1.
PubMed 17194239
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Information on Placebo in the Informed Consent on the Trial Outcomes and Participant Blinding
- ClinicalTrials.gov ID
- NCT04182295
- Acronym / sponsor ID
- KHSIRB-19-173
- Conditions
- Muscle Soreness
- Keywords
- Placebo, Informed consent, Participant information leaflet, Outcome, Blinding, Sham, Acupuncture, Delayed Onset Muscle Soreness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Kyunghee UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Dec 2019 (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 is a randomised sham-controlled trial involving healthy volunteers to determine the effect of information on placebo, i.e., sham acupuncture, given in the informed consent, on the trial outcomes and blinding status of participants in a trial.
Detailed description
A total of 89 healthy volunteers will be recruited and randomly allocated to one of the 4 groups at an identical ratio. Four groups differ in acupuncture and placebo information. It is summarized as follows:
- to receive real acupuncture and to read fully disclosed sham acupuncture information (e.g., fake acupuncture) written in the informed consent
- to receive real acupuncture and to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent
- to receive sham acupuncture (Park Sham Needle) and to read fully disclosed sham acupuncture information written in the informed consent
- to receive sham acupuncture to read partially disclosed sham acupuncture information (e.g., different kind of acupuncture) written in the informed consent.
They will read informed consent with differently described placebo information following their allocation. After participants repeatedly lift a dumbbell with their non-dominant arm to induce delayed onset muscle soreness (DOMS) in their biceps brachii, they are given allocated acupuncture treatment once a day for three consecutive days including the very first visit to compare outcomes (i.e., relief of DOMS measured with pressure pain threshold and visual analogue scale) and blinding property (the participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of real, sham, or don't know options).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| real acupuncture-full disclosure | Experimental | Device: acupunctureParticipants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture). |
| real acupuncture-partial disclosure | Experimental | Device: acupunctureParticipants in this group will be given real acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture). |
| sham acupuncture-full disclosure | Sham comparator | Device: Park Sham NeedleParticipants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and fully disclosed sham acupuncture information in the informed consent (i.e., fake acupuncture). |
| sham acupuncture-partial disclosure | Sham comparator | Device: Park Sham NeedleParticipants in this group will be given sham acupuncture once a day for three consecutive days including the very first visit and partially disclosed sham acupuncture information in the informed consent (i.e., different kind of acupuncture). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age over 18
- not participating in other studies at the time of study participation
- voluntary participation
Key exclusion criteria (5 listed)
- resistance training for more than 6 months
- experience of fracture of any of four limbs
- pregnancy or breast-feeding at the time of study participation
- analgesics within 24 hours before participation
- any other diseases or conditions that might prevent the participant from receiving acupuncture
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 |
|---|---|---|
| acupunctureA sterilised stainless steel needle (diameter 0.25mm X length 40mm, Dongbang Acupuncture Inc., Boryeong, Chungchenongnam-do, Korea) will be given at PC3, LI4, LI11, and LU5 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS). | Device | real acupuncture-full disclosure, real acupuncture-partial disclosure |
| Park Sham NeedleAlso: sham acupunctureA Park Sham Needle (Meridius Medical Ltd. \& DongBang Acuprime Ltd., Exeter, UK), non-penetrating sham acupuncture, will be given at two points on the belly of biceps brachii, 1 cun proximedially from LI11, and 1 cun laterally from PC3 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS). | Device | sham acupuncture-full disclosure, sham acupuncture-partial disclosure |
Primary outcome
the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS)
Time frame: day 0; day 1; day 2
Muscle discomfort of DOMS induced arm is evaluated with VAS ranging from 0 to 10 cm (with 0 indicating no discomfort and 10 experiencing the worst imaginable muscle discomfort.)
Blinding property
Time frame: day 2
Blinding property is evaluated: participants will be asked 'which type of acupuncture do you think you have received?' and choose 1 answer out of experimental group, control group, and do not know. It is calculated following the way of Bang's Blind Index; -1 indicates opposite guessing; 0 indicates random guessing; 1 indicates correct guessing.
the change in Pressure Pain Threshold (PPT) from baseline, i.e., before being induced DOMS
Time frame: day 0; day 1; day 2
Pressure Pain Threshold (PPT) will be evaluated on the 5 points of upper non-dominant arm. Five points are selected from 6 equidistance from origin to insertion of biceps brachii with an exception of the first and last point, perpendicular to the belly of the biceps brachii. Pressure was applied to each of these points with increasing force at a rate of approximately 10 N/cm2*sec until the participant reported a painful sensation, and the force value was recorded (N/cm2). An upper limit of PPt was set 50 N/cm2 to avoid bruising.
1 secondary outcome
Acupuncture sensation measured by De-qi questionnaire
Time frame: day 0; day 1; day 2
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 2 Sep 2020.
- Background: PubMed 15020033Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004 Apr;25(2):143-56. doi: 10.1016/j.cct.2003.10.016.
- Background: PubMed 22761859Bishop FL, Adams AE, Kaptchuk TJ, Lewith GT. Informed consent and placebo effects: a content analysis of information leaflets to identify what clinical trial participants are told about placebos. PLoS One. 2012;7(6):e39661. doi: 10.1371/journal.pone.0039661. Epub 2012 Jun 27.
- Background: PubMed 29347917Cheon S, Park HJ, Chae Y, Lee H. Does different information disclosure on placebo control affect blinding and trial outcomes? A case study of participant information leaflets of randomized placebo-controlled trials of acupuncture. BMC Med Res Methodol. 2018 Jan 18;18(1):13. doi: 10.1186/s12874-018-0474-1.
- Background: PubMed 14519842Gillon R. Ethics needs principles--four can encompass the rest--and respect for autonomy should be "first among equals". J Med Ethics. 2003 Oct;29(5):307-12. doi: 10.1136/jme.29.5.307.
- Background: PubMed 14519841Harris J. In praise of unprincipled ethics. J Med Ethics. 2003 Oct;29(5):303-6. doi: 10.1136/jme.29.5.303.
- Results publication: PubMed 26957941Corder KE, Newsham KR, McDaniel JL, Ezekiel UR, Weiss EP. Effects of Short-Term Docosahexaenoic Acid Supplementation on Markers of Inflammation after Eccentric Strength Exercise in Women. J Sports Sci Med. 2016 Feb 23;15(1):176-83. eCollection 2016 Mar.
- Results publication: PubMed 12230902Dennehy EB, Webb A, Suppes T. Assessment of beliefs in the effectiveness of acupuncture for treatment of psychiatric symptoms. J Altern Complement Med. 2002 Aug;8(4):421-5. doi: 10.1089/107555302760253612.
- Results publication: PubMed 26540600Fleckenstein J, Niederer D, Auerbach K, Bernhorster M, Hubscher M, Vogt L, Banzer W. No Effect of Acupuncture in the Relief of Delayed-Onset Muscle Soreness: Results of a Randomized Controlled Trial. Clin J Sport Med. 2016 Nov;26(6):471-477. doi: 10.1097/JSM.0000000000000259.
- Results publication: PubMed 28985238Fleckenstein J, Simon P, Konig M, Vogt L, Banzer W. The pain threshold of high-threshold mechanosensitive receptors subsequent to maximal eccentric exercise is a potential marker in the prediction of DOMS associated impairment. PLoS One. 2017 Oct 6;12(10):e0185463. doi: 10.1371/journal.pone.0185463. eCollection 2017.
- Results publication: PubMed 3246465Graves JE, Pollock ML, Leggett SH, Braith RW, Carpenter DM, Bishop LE. Effect of reduced training frequency on muscular strength. Int J Sports Med. 1988 Oct;9(5):316-9. doi: 10.1055/s-2007-1025031.
- Results publication: PubMed 18990049Hubscher M, Vogt L, Bernhorster M, Rosenhagen A, Banzer W. Effects of acupuncture on symptoms and muscle function in delayed-onset muscle soreness. J Altern Complement Med. 2008 Oct;14(8):1011-6. doi: 10.1089/acm.2008.0173.
- Results publication: PubMed 24401940Kam-Hansen S, Jakubowski M, Kelley JM, Kirsch I, Hoaglin DC, Kaptchuk TJ, Burstein R. Altered placebo and drug labeling changes the outcome of episodic migraine attacks. Sci Transl Med. 2014 Jan 8;6(218):218ra5. doi: 10.1126/scitranslmed.3006175.
- 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.
Hyangsook Lee, Doctor principal investigator
Kyunghee 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 acupuncture in people with Muscle Soreness, run by Kyunghee University at 1 site in South Korea.
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 3 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: finished, as of the sponsor's last update on 2 Sep 2020. 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in muscle discomfort from baseline, i.e., immediately after being induced DOMS, measured by visual analogue scale (VAS) (time frame: day 0; day 1; day 2). The study lists 3 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 NCT04182295, 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 2 Sep 2020.