Influence of Expectations on Change in Pain Perception After a 3 Min Wallsquat Exercise.
The Influence of Expectations Induced by Information Prior to Exercise on the Change in Pain Perception After a 3 Min Wallsquat Exercise in Healthy Subjects: A Randomized Controlled Trial.
1 other identifier
interventional
83
1 country
1
Brief Summary
The purpose of this study is to investigate how expectations induced by information given prior to exercise influence the magnitude of exercise-induced hypoalgesia after a 3 min wallsquat exercise in healthy subjects. The study is a double blinded (participant, investigator) randomized controlled trial The results from the study may be of great importance to the understanding of exercise-induced hypoalgesia, and whether the information related to exercise as pain relief can be used in practice for patients with pain. The subjects are randomized to 1 in 3 groups. Hypoalgesia expectation, hyperalgesia expectation, neutral expectation. Each group (besides the neutral group) is given different information of what to expect on pain ratings after a 3 minutes wallsquat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Sep 2018
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
September 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2018
CompletedNovember 26, 2018
November 1, 2018
2 months
September 12, 2018
November 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pressure pain threshold
Between group comparison of the primary outcome, change in pressure pain threshold from baseline to post test. Pressure pain threshold is measured with a cuff algometer and pressure algometer respectively. Pressure pain threshold is measured in Kilopascal with rising pressure from 0 to infinity Kilopascal on the pressure algometer and from 0 to 100 Kilopascal on the cuff algometer. The cuff algometer is self-administered by the subject with a handheld joypad illustrating a Visual Analog Scala. Pressure pain threshold is registered in the computer when the subject reaches 0.1 centimeter and 1 centimeter on Visual Analog Scala on the joypad.
At baseline before randomization and after the 3 minutes wallsquat - Day 1
Pressure pain tolerance
Between group comparison of the primary outcome, change in pressure pain tolerance from baseline to post test.. Pressure pain tolerance is measured with a cuff algometer. Pressure pain tolerance is measured in Kilopascal with rising pressure from 0 to 100 Kilopascal. The cuff algometer is self-administered by the subject with a handheld joypad illustrating a Visual Analog Scala. Pressure pain tolerance is registered in the computer when the subject reaches 10 centimeter on Visual Analog Scala on the joypad. If the 100 kilopascal on the cuff algometer is reached before the subjects maximum tolerance, the present score on Visual Analog Scala is assessed.
At baseline before randomization and after the 3 minutes wallsquat - Day 1
Secondary Outcomes (3)
Retrospective expectation for hypoalgesia and hyperalgesia after 3 minutes wall squat.
Post-test score at day 1 (immediately after the last pain rating)
Numeric Pain Rating Scale (NPRS)
Test score at day 1 (during the 3 minute wall squat)
International Physical Activity Questionaires (IPAQ)
Pre test, baseline - day 1
Study Arms (3)
hyperalgesia expectation
EXPERIMENTALIn this group the subjects will be told that the 3 minutes wall squat will have pain-enhancing effects.
hypoalgesia expectation
EXPERIMENTALIn this group the subjects will be told that the 3 minutes wall squat will have pain-diminishing effects.
Neutral
ACTIVE COMPARATORIn this group the subjects expectations are not manipulated
Interventions
"Before and after the squat exercise, assessment of how you experience pressure pain with the 2 devices you have just become acquainted with will be repeated. While doing the squat exercise you will be asked to indicate pain in the thigh muscles. What we currently know about the effect of exercise on the experience of pressure pain is that after eg. cycling or walking, more pressure can be applied before the pressure starts to hurt and more pressure is required before you can't withstand anymore. Whether this applies to a squat exercise, as the one you are about to perform, has not yet been investigated, but we expect that the same applies here, namely, that more pressure is required before you feel the pressure begins to hurt you and you will be able to endure a greater pressure." Supported by visual information.
"Before and after the squat exercise, assessment of how you experience pressure pain with the 2 devices you have just become acquainted with will be repeated. While doing the squat exercise you will be asked to indicate pain in the thigh muscles. What we currently know is that exercise can cause muscle pain, both during and after training. You may have experienced muscle soreness yourself in relation to training? We expect that the same will apply here. Namely, after performing this squat exercise, which will likely hurt your thigh muscles while doing it, you will experience that the pressure applied afterwards, with the two devices you have just become acquainted with, should be less before it starts to hurt and that you can endure less pressure." Supported by visual information.
"Soon you are going to do a training exercise in a squat position up against the wall for 3 min. Following the squat exercise, we will repeat the measurement of how you experience pressure pain with the 2 devices you have just become acquainted with. While doing the squat exercise you will be asked to indicate pain in the thigh muscles."
Eligibility Criteria
You may qualify if:
- Healthy subjects without current recurrent or prolonged painful diseases.
- The subjects should speak and understand Danish.
You may not qualify if:
- Pregnancy
- Previous addictive behavior defined as abuse of hash, opioids or other euphoric substances.
- Previous painful or mental illnesses, neurological or circulatory diseases in the form of heart or lung disease.
- Lack of co-operation.
- Subjects who perform elite sports.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- University of Southern Denmarkcollaborator
Study Sites (1)
Pain Center South
Odense, Fyn, 5000, Denmark
Related Publications (1)
Vaegter HB, Thinggaard P, Madsen CH, Hasenbring M, Thorlund JB. Power of Words: Influence of Preexercise Information on Hypoalgesia after Exercise-Randomized Controlled Trial. Med Sci Sports Exerc. 2020 Nov;52(11):2373-2379. doi: 10.1249/MSS.0000000000002396.
PMID: 32366799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gitte Handberg, MD
Pain Center, OUH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Participants will not be aware of which group they are allocated to. The experimenter who is assessing pressure pain threshold and tolerance is blinded to the study group of the participant.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Stud. M.Sc. Physiotherapy
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 19, 2018
Study Start
September 19, 2018
Primary Completion
November 22, 2018
Study Completion
November 22, 2018
Last Updated
November 26, 2018
Record last verified: 2018-11