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Efficacy of Stretching on Pain Sensitivity

Primary Purpose

Pain Threshold

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Stretch exercises
Sponsored by
University College of Northern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain Threshold focused on measuring Stretching, Pain sensitivity, Range of motion, Exercise adherence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University College of Northern Denmark

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stretching

Arm Description

Static stretching of the knee flexors

Outcomes

Primary Outcome Measures

Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer

Secondary Outcome Measures

Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer

Full Information

First Posted
June 1, 2021
Last Updated
April 19, 2023
Sponsor
University College of Northern Denmark
Collaborators
Bispebjerg Hospital, University of Copenhagen, Research Unit of General Practice, Aalborg
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1. Study Identification

Unique Protocol Identification Number
NCT04919681
Brief Title
Efficacy of Stretching on Pain Sensitivity
Official Title
Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 4, 2021 (Actual)
Primary Completion Date
April 25, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College of Northern Denmark
Collaborators
Bispebjerg Hospital, University of Copenhagen, Research Unit of General Practice, Aalborg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Threshold
Keywords
Stretching, Pain sensitivity, Range of motion, Exercise adherence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-blind longitudinal repeated measures study
Masking
None (Open Label)
Masking Description
Participants are blinded to the results of the pressure pain threshold measurements. Participants and examiner are blinded to the results of the range of motion and passive resistive torque measurements.
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching
Arm Type
Experimental
Arm Description
Static stretching of the knee flexors
Intervention Type
Other
Intervention Name(s)
Stretch exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain sensitivity
Description
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Time Frame
Baseline
Title
Pain sensitivity
Description
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Time Frame
6 weeks
Title
Pain sensitivity
Description
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Range of motion
Description
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
Baseline
Title
Range of motion
Description
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
6 weeks
Title
Range of motion
Description
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
10 weeks
Title
Passive resistive torque
Description
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
Baseline
Title
Passive resistive torque
Description
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
6 weeks
Title
Passive resistive torque
Description
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Adherence to the stretching protocol
Description
Adherence to the stretching protocol will be measured using self-reported data from an mHealth app.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorte Drachmann, Msc.
Organizational Affiliation
Department of physiotherapy, University College of Northern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
University College of Northern Denmark
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is made available upon request.
IPD Sharing Time Frame
Study protocol will be published
IPD Sharing Access Criteria
The study protocol will be published open access

Learn more about this trial

Efficacy of Stretching on Pain Sensitivity

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