NCT03678662

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

2 months

First QC Date

September 12, 2018

Last Update Submit

November 23, 2018

Conditions

Keywords

Exercise-induced hypoalgesia, expectation, pain sensitivity

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

EXPERIMENTAL

In this group the subjects will be told that the 3 minutes wall squat will have pain-enhancing effects.

Other: Neutral

hypoalgesia expectation

EXPERIMENTAL

In this group the subjects will be told that the 3 minutes wall squat will have pain-diminishing effects.

Other: Hypoalgesia expectation

Neutral

ACTIVE COMPARATOR

In this group the subjects expectations are not manipulated

Other: Hyperalgesia expectation

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.

Also known as: Randomization group a
hypoalgesia expectation

"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.

Also known as: Randomization group b
Neutral
NeutralOTHER

"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."

Also known as: Randomization group c
hyperalgesia expectation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Pain Center South

Odense, Fyn, 5000, Denmark

Location

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.

MeSH Terms

Conditions

PainMotor Activity

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gitte Handberg, MD

    Pain Center, OUH

    STUDY DIRECTOR

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

Locations