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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04919681
Other study ID # UniversityCND3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 4, 2021
Est. completion date October 20, 2022

Study information

Verified date April 2023
Source University College of Northern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date October 20, 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Stretch exercises
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.

Locations

Country Name City State
Denmark University College of Northern Denmark Aalborg

Sponsors (4)

Lead Sponsor Collaborator
University College of Northern Denmark Bispebjerg Hospital, Research Unit of General Practice, Aalborg, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Adherence to the stretching protocol Adherence to the stretching protocol will be measured using self-reported data from an mHealth app. 6 weeks
Primary Pain sensitivity The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer Baseline
Primary Pain sensitivity The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer 6 weeks
Primary Pain sensitivity The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer 10 weeks
Secondary Range of motion Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer Baseline
Secondary Range of motion Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer 6 weeks
Secondary Range of motion Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer 10 weeks
Secondary Passive resistive torque Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer Baseline
Secondary Passive resistive torque Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer 6 weeks
Secondary Passive resistive torque Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer 10 weeks
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