Does Placebo Information Affect the Trial Outcomes and Participant Blinding?

NCT04182295 | Completed

• 1 other identifier: KHSIRB-19-173
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Soreness

Keywords

Placebo; Informed consent; Participant information leaflet; Outcome; Blinding; Sham; Acupuncture; Delayed Onset Muscle Soreness

Outcome Measures

Primary Outcomes (3)

• 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.)

  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.

  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.

  day 0; day 1; day 2

Secondary Outcomes (1)

• Acupuncture sensation measured by De-qi questionnaire

  day 0; day 1; day 2

Other Outcomes (3)

• Acupuncture credibility

  day 0; day 2

• Acupuncture Belief Scale (ABS)

  day 0

• State-Trait Anxiety Inventory-X (STAI-X)

  day 0

Study Arms (4)

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).

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).

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).

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).

Device: Park Sham Needle

Interventions

acupuncture DEVICE

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).

real acupuncture-full disclosure; real acupuncture-partial disclosure

Park Sham Needle DEVICE

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).

Also known as: sham acupuncture

sham acupuncture-full disclosure; sham acupuncture-partial disclosure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18
• not participating in other studies at the time of study participation
• voluntary participation

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University: lead
• University of California, Davis: collaborator

Study Sites (1)

Acupuncture & Meridian Science Research Centre

Seoul, 02447, South Korea

Location

Related Publications (16)

• 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.

  PMID: 15020033 BACKGROUND

• Bishop 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.

  PMID: 22761859 BACKGROUND

• Cheon 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.

  PMID: 29347917 BACKGROUND

• Gillon 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.

  PMID: 14519842 BACKGROUND

• Harris J. In praise of unprincipled ethics. J Med Ethics. 2003 Oct;29(5):303-6. doi: 10.1136/jme.29.5.303.

  PMID: 14519841 BACKGROUND

• Corder 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.

  PMID: 26957941 RESULT

• Dennehy 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.

  PMID: 12230902 RESULT

• Fleckenstein 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.

  PMID: 26540600 RESULT

• Fleckenstein 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.

  PMID: 28985238 RESULT

• Graves 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.

  PMID: 3246465 RESULT

• Hubscher 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.

  PMID: 18990049 RESULT

• Kam-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.

  PMID: 24401940 RESULT

• Lin 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.

  PMID: 29354073 RESULT

• Myers 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.

  PMID: 3621780 RESULT

• Shimano 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.

  PMID: 17194239 RESULT

• Webster RK, Weinman J, Rubin GJ. Positively Framed Risk Information in Patient Information Leaflets Reduces Side Effect Reporting: A Double-Blind Randomized Controlled Trial. Ann Behav Med. 2018 Oct 22;52(11):920-929. doi: 10.1093/abm/kax064.

  PMID: 30346496 RESULT

MeSH Terms

Conditions

Myalgia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hyangsook Lee, Doctor

  Kyunghee University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 2, 2019
• Study Start: October 7, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)