- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05299268
Influence of Pain on Exercise-induced Hypoalgesia
The Influence of Pain on Exercise-Induced Hypoalgesia in Healthy Women
Study Overview
Status
Intervention / Treatment
Detailed Description
Exercise is recommended to promote and maintain health and as treatment for more than 25 chronic diseases and pain conditions.
The mechanisms underlying pain relief of exercise are largely unknown but may be related to the modulation of central descending pain inhibitory pathways after acute exercise bouts. Exercise-induced hypoalgesia (EIH) is typically assessed as the temporary change in pressure pain thresholds (PPT) after a short acute exercise bout and EIH is seen as a proxy of descending pain inhibitory control. In general, EIH seems hypoalgesic (functional) in asymptomatic subjects. A hyperalgesic (impaired) EIH response has been reported in different chronic pain populations, although a functional EIH response also has been reported in subgroups of knee osteoarthritis patients. This implies differences in the acute response to exercise between healthy (pain-free) subjects and chronic pain patients, but it is still unknown whether the presence of pain itself affects the pain alleviating response (i.e. the EIH response) to acute exercise.
It is hypothesized that acute pain will decrease the EIH response magnitude following hypertonic saline injection compared with the control injection. This study will increase the insight into the EIH mechanisms in healthy subjects in general, and how the presence of pain affects the body's own ability to modulate pain during exercise.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalborg, Denmark, 9220
- Dept. Of Health Science and Technology, Aalborg University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain-free
- Understands and writes Danish
Exclusion Criteria:
- Pregnancy
- Previous addictive behaviour 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.
- Surgery in the lower extremities within the last 12 months
- Chronic or actual pain on the days of testing
- Under the influence on the days of testing
- Inability to cooperate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Pain (hypertonic saline)
Injection (1 ml) of painful hypertonic saline (5.8%) prior to performance of the 1x3 min Seated Isometric Knee Extension
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A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension.
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Placebo Comparator: No pain (isotonic saline)
Injection (1 ml) of non-painful isotonic saline (0.9%) prior to performance of the 1x3 min Seated Isometric Knee Extension
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A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pressure pain threshold will be assessed over the dominant quadriceps muscle
Time Frame: Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)
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Between group comparison of the primary outcome, which is change in pressure pain threshold over the dominant quadriceps muscle before and after performing seated isometric knee extension. Pressure pain threshold is measured with a handheld pressure algometer. |
Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold at the non-dominant quadriceps muscle and non-dominant trapezius muscle
Time Frame: Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)
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Between group comparison of the secondary outcome, which is change in pressure pain threshold at the non-dominant quadriceps muscle and non-dominant trapezius muscle from before Seated Isometric Knee Extension to after Seated Isometric Knee Extension. Pressure pain threshold is measured with a handheld pressure algometer. |
Baseline, Day 2 (within 1 week of baseline), Day 3 (within 1 week of Day 2)
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Pain Intensity in dominant thigh
Time Frame: Assessed before and immediately after hypertonic and isotonic saline injection as well as 1, 2 and 3 minutes into the Seated Isometric Knee Extension, and immediately after the end of the seated isometric knee extension
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Pain intensity is assessed with numerical rating scales with 0 = no pain and 10 = maximal pain.
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Assessed before and immediately after hypertonic and isotonic saline injection as well as 1, 2 and 3 minutes into the Seated Isometric Knee Extension, and immediately after the end of the seated isometric knee extension
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure pain threshold at the dominant and non-dominant thigh as well as non-dominant trapezius muscle
Time Frame: Before and after determining maximal voluntary contraction on the fist test day and prior to saline injections
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Pressure pain threshold is measured with a handheld pressure algometer.
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Before and after determining maximal voluntary contraction on the fist test day and prior to saline injections
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Rating of perceived exertion (RPE)
Time Frame: Assessed 1, 2 and 3 minutes into the Seated Isometric Knee Extension
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Perceived exertion is assessed with Borg RPE scale with 6 = no exertion and 20 = maximal exertion
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Assessed 1, 2 and 3 minutes into the Seated Isometric Knee Extension
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Quantifying the individual´s pain experience
Time Frame: Baseline
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Quantifying the individual´s pain experience will be assessed using the Pain Catastrophizing Scale (PCS) at the first session.
The pain catastrophizing scale have 13 sentences regarding pain-related thoughts.
Participants are asked to indicate how well each sentence applies for them: 0 = not at all, 1 = to a slight degree, 2 = to a moderate degree, 3 = to a great degree and 4 = all the time.
A higher score is worse
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Baseline
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Pain experience
Time Frame: Day 3 (within 2-3 weeks of the initial session)
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Participants will be interviewed at the end of the study regarding the experience of pain during the study.
The interview will be conducted after all other experimental procedures have been completed.
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Day 3 (within 2-3 weeks of the initial session)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steffan WM Christensen, PhD, Aalborg University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S-20210184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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