- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919681
Efficacy of Stretching on Pain Sensitivity
Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.
The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark, 9220
- University College of Northern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as
- cognitive impairments,
- neurological,
- orthopaedic,
- or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.
Exclusion Criteria:
- Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)
- or use any medication that might affect the somatosensory system, such as pain medication, are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stretching
Static stretching of the knee flexors
|
The intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors.
Stretches are performed seated on the ground.
The participant sits upright on the floor with one leg straight.
The sole of the other foot should be placed on the inside of the outstretched leg.
The participant leans slightly forward, trying to touch their toes while maintaining full knee extension.
Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain sensitivity
Time Frame: Baseline
|
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
|
Baseline
|
Pain sensitivity
Time Frame: 6 weeks
|
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
|
6 weeks
|
Pain sensitivity
Time Frame: 10 weeks
|
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: Baseline
|
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
|
Baseline
|
Range of motion
Time Frame: 6 weeks
|
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
|
6 weeks
|
Range of motion
Time Frame: 10 weeks
|
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
|
10 weeks
|
Passive resistive torque
Time Frame: Baseline
|
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
|
Baseline
|
Passive resistive torque
Time Frame: 6 weeks
|
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
|
6 weeks
|
Passive resistive torque
Time Frame: 10 weeks
|
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to the stretching protocol
Time Frame: 6 weeks
|
Adherence to the stretching protocol will be measured using self-reported data from an mHealth app.
|
6 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Dorte Drachmann, Msc., Department of physiotherapy, University College of Northern Denmark
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversityCND3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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