PainNCT03678662
Influence of Expectations on Change in Pain Perception After a 3 Min Wallsquat Exercise.
A study testing Hypoalgesia expectation, Hyperalgesia expectation and Neutral in people with Pain and Physical Activity, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Physical Activity
- What is being tested?
- Hypoalgesia expectation, Hyperalgesia expectation and Neutral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Sep 2018to 22 Nov 2018
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without current recurrent or prolonged painful diseases.
- The subjects should speak and understand Danish.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read the detailed description
Painful conditions are a major societal and economic problem and in Denmark, almost every fifth person suffers from long-lasting pain. Effective treatment of these conditions is vital not only to alleviate the pain but also to prevent repeated episodes of personal disorder and impaired work ability. Based on the hypothesis that physical activity and exercise lead to a change in pain perception, Pain Center South, Odense University Hospital has conducted a series of research projects which have investigated the immediate effect of various types of acute exercise on the pain sensitivity of both healthy subjects, patients with chronic pain in the knee and in patients with more 'complex' chronic pain who were referred to treatment at the Pain Center. The results showed that healthy subjects achieved a reduced overall pain sensitivity after both high intensity aerobic exercise (cycling) and low and high intensity isometric training (strength-like exercise on the arm and leg). This phenomenon is called 'exercise-induced hypoalgesia' or 'training-induced pain relief'. A recently published study from Australia has also shown that the effect of exercise can be positively influenced by the information given prior to exercise, indicating that some of the experience of exercise may be related to expectations of the effect. This may be one of the reasons why patients with chronic pain do not experience a positive effect, as opposed to healthy people, as chronic pain patients may previously have experienced no effect of exercise or perhaps even worsening / flareup in post-workout pain.
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 pain sensitivity of the deep structures is investigated with two different pressure-gauges for the testing of mechanical pressure pain sensitivity. Pain sensitivity is examined on the leg and arm before and after the exercise. Pressure-sensitivity is evaluated using a handheld pressure-algometer for testing mechanical pressure pain-threshold in the deeper musculoskeletal structures. The pain-threshold is evaluated on the thigh and shoulder.
To investigate additional facets of pain-sensitivity, computer-controlled cuff geometry is used. The computer-controlled cuff algorithm is less affected by local differences in pain sensitivity to the handheld pressure algometer and the cuff algorithm can also affect a larger portion of the deep tissue than the pressure algometer can.
The cuff gauge consists of a blood pressure cuff placed around one lower leg and then slowly inflated. The pain response is registered continuously and the stimulus response function can then be established. The cuff algorithm has a maximum pressure that ensures no tissue damage to the subject and the device is automatically stopped at 100 kPa. Both the handheld pressure gauge and the cuff algorithm have proven to be a valid and reliable techniques for investigating the pain-sensitivity of healthy subjects.
The person performing the measurements before and after the exercise is blinded to what information the subject has received, likewise the patient is blinded to the group randomization.
- Conditions
- Pain, Physical Activity
- Being tested
- Hypoalgesia expectation, Hyperalgesia expectation, Neutral
- Keywords
- Exercise-induced hypoalgesia, expectation, pain sensitivity
- Medical subject headings
- Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoalgesia expectationOther
Also called Randomization group a
"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.
Hyperalgesia expectationOther
Also called Randomization group b
"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.
NeutralOther
Also called Randomization group c
"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."
| Study group | Role | What they receive |
|---|---|---|
| hyperalgesia expectation | Experimental | In this group the subjects will be told that the 3 minutes wall squat will have pain-enhancing effects. Receives: Other: Neutral |
| hypoalgesia expectation | Experimental | In this group the subjects will be told that the 3 minutes wall squat will have pain-diminishing effects. Receives: Other: Hypoalgesia expectation |
| Neutral | Active comparator | In this group the subjects expectations are not manipulated Receives: Other: Hyperalgesia expectation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Three item self-reported questionaire about the subjects retrospective expectations to change in pain ratings for pain tolerance and for pain threshold at both sites (quadriceps and trapezius) after a 3 minutes wall squat. The questionaire is retrospective and will be used after all test procedures is done and therefore not indicate the subjects prospective expectation. The questions will be scored from -10 to +10. Whereas -10 indicates the subjects retrospective expectations of much more pain and +10 indicates the subjects retrospective expectations of much less pain.
Measured: Post-test score at day 1 (immediately after the last pain rating)
Numeric Pain Rating Scale (NPRS)
Between group comparison of maximum pain intensity. Pain intensity is measured on Numeric Pain Rating Scale (NPRS) during wall squat. The NPRS is a segmented numeric pain scale in which the subject selects a whole number from 0 to 10 that best reflects the intensity of his/her pain. Whereas 0 is no pain and 10 is the worst possible pain.
Measured: Test score at day 1 (during the 3 minute wall squat)
International Physical Activity Questionaires (IPAQ)
The IPAQ is suitable for adults between 15 and 69 years of age and is used for sample surveillance of physical activity levels.
Measured: Pre test, baseline - day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start19 Sep 2018
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Peter Thinggaard, Odense University Hospital
- Investigators
- Gitte Handberg, MD, Study director, Pain Center, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678662
- Sponsor's protocol ID
- 62039
- Status last verified
- Nov 2018
- First submitted
- 12 Sep 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32366799
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03678662
- Acronym / sponsor ID
- 62039
- Conditions
- Pain, Physical Activity
- Keywords
- Exercise-induced hypoalgesia, expectation, pain sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 19 Sep 2018 (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.
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.
Detailed description
Painful conditions are a major societal and economic problem and in Denmark, almost every fifth person suffers from long-lasting pain. Effective treatment of these conditions is vital not only to alleviate the pain but also to prevent repeated episodes of personal disorder and impaired work ability. Based on the hypothesis that physical activity and exercise lead to a change in pain perception, Pain Center South, Odense University Hospital has conducted a series of research projects which have investigated the immediate effect of various types of acute exercise on the pain sensitivity of both healthy subjects, patients with chronic pain in the knee and in patients with more 'complex' chronic pain who were referred to treatment at the Pain Center. The results showed that healthy subjects achieved a reduced overall pain sensitivity after both high intensity aerobic exercise (cycling) and low and high intensity isometric training (strength-like exercise on the arm and leg). This phenomenon is called 'exercise-induced hypoalgesia' or 'training-induced pain relief'. A recently published study from Australia has also shown that the effect of exercise can be positively influenced by the information given prior to exercise, indicating that some of the experience of exercise may be related to expectations of the effect. This may be one of the reasons why patients with chronic pain do not experience a positive effect, as opposed to healthy people, as chronic pain patients may previously have experienced no effect of exercise or perhaps even worsening / flareup in post-workout pain.
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 pain sensitivity of the deep structures is investigated with two different pressure-gauges for the testing of mechanical pressure pain sensitivity. Pain sensitivity is examined on the leg and arm before and after the exercise. Pressure-sensitivity is evaluated using a handheld pressure-algometer for testing mechanical pressure pain-threshold in the deeper musculoskeletal structures. The pain-threshold is evaluated on the thigh and shoulder.
To investigate additional facets of pain-sensitivity, computer-controlled cuff geometry is used. The computer-controlled cuff algorithm is less affected by local differences in pain sensitivity to the handheld pressure algometer and the cuff algorithm can also affect a larger portion of the deep tissue than the pressure algometer can.
The cuff gauge consists of a blood pressure cuff placed around one lower leg and then slowly inflated. The pain response is registered continuously and the stimulus response function can then be established. The cuff algorithm has a maximum pressure that ensures no tissue damage to the subject and the device is automatically stopped at 100 kPa. Both the handheld pressure gauge and the cuff algorithm have proven to be a valid and reliable techniques for investigating the pain-sensitivity of healthy subjects.
The person performing the measurements before and after the exercise is blinded to what information the subject has received, likewise the patient is blinded to the group randomization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hyperalgesia expectation | Experimental | Other: NeutralIn this group the subjects will be told that the 3 minutes wall squat will have pain-enhancing effects. |
| hypoalgesia expectation | Experimental | Other: Hypoalgesia expectationIn this group the subjects will be told that the 3 minutes wall squat will have pain-diminishing effects. |
| Neutral | Active comparator | Other: Hyperalgesia expectationIn this group the subjects expectations are not manipulated |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects without current recurrent or prolonged painful diseases.
- The subjects should speak and understand Danish.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Hypoalgesia expectationAlso: Randomization group a"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. | Other | hypoalgesia expectation |
| Hyperalgesia expectationAlso: Randomization group b"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. | Other | Neutral |
| NeutralAlso: Randomization group c"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." | Other | hyperalgesia expectation |
Primary outcome
Pressure pain threshold
Time frame: At baseline before randomization and after the 3 minutes wallsquat - Day 1
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.
Pressure pain tolerance
Time frame: At baseline before randomization and after the 3 minutes wallsquat - Day 1
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.
3 secondary outcomes
Retrospective expectation for hypoalgesia and hyperalgesia after 3 minutes wall squat.
Time frame: Post-test score at day 1 (immediately after the last pain rating)
Numeric Pain Rating Scale (NPRS)
Time frame: Test score at day 1 (during the 3 minute wall squat)
International Physical Activity Questionaires (IPAQ)
Time frame: Pre test, baseline - day 1
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 26 Nov 2018.
- Derived from this study: PubMed 32366799Vaegter 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.
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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.
Gitte Handberg, MD study director
Pain Center, OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoalgesia expectation, Hyperalgesia expectation and Neutral in people with Pain and Physical Activity, run by Odense University Hospital at 1 site in Denmark.
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 2 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 26 Nov 2018. 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 Denmark. 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?
Pressure pain threshold (time frame: At baseline before randomization and after the 3 minutes wallsquat - Day 1). The study lists 2 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 NCT03678662, which also lists 1 linked publication.
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 26 Nov 2018.