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The Effect of Stretching Intensity on Pain Sensitivity

Primary Purpose

Pain Threshold, Stretching, Pain Sensitivity

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Static stretching
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

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy men and women aged 18-55 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Exclusion Criteria: 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.

Sites / Locations

  • University College of Northern DenmarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Static stretching to the point of pain

Static stretching to the point of discomfort

Arm Description

The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain.

The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort.

Outcomes

Primary Outcome Measures

Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer

Secondary Outcome Measures

Knee extension range of motion
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Knee extension range of motion
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Passive resistive torque
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
Passive resistive torque
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer

Full Information

First Posted
July 2, 2023
Last Updated
September 13, 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
NCT05989490
Brief Title
The Effect of Stretching Intensity on Pain Sensitivity
Official Title
The Effect of Stretching Intensity on Pain Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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 stretching intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized that the analgesic effect of stretching may be linked with the intensity of stretching in a dose-response relationship.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Threshold, Stretching, Pain Sensitivity, Range of Motion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This was a randomized, repeated-measures cross-over study. The interventions consist of two different stretching protocols (e.g., stretching to the point of discomfort and stretching to the point of pain). Subjects were randomized to one of two groups (pain first or discomfort first). Both groups underwent a static stretch protocol consisting of four bouts of thirty-second constant-angle static stretching of the knee flexors with a 20-second rest period between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension to the point of discomfort and the point of pain.
Masking
ParticipantInvestigator
Masking Description
Participants were blinded to the results of all measurements and naïve to research hypotheses. The investigator was blinded to the results of all measurements.
Allocation
Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Static stretching to the point of pain
Arm Type
Experimental
Arm Description
The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain.
Arm Title
Static stretching to the point of discomfort
Arm Type
Experimental
Arm Description
The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort.
Intervention Type
Other
Intervention Name(s)
Static stretching
Intervention Description
The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort and to the point of pain.
Primary Outcome Measure Information:
Title
Pressure pain thresholds
Description
Pressure pain thresholds was measures using a handheld pressure algometer
Time Frame
Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Title
Pressure pain thresholds
Description
Pressure pain thresholds was measures using a handheld pressure algometer
Time Frame
Pressure pain thresholds were measured immediately after stretching
Secondary Outcome Measure Information:
Title
Knee extension range of motion
Description
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Time Frame
Passive knee extension range of motion was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Title
Knee extension range of motion
Description
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Time Frame
Passive knee extension range of motion was measured immediately after stretching
Title
Passive resistive torque
Description
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
Time Frame
Passive resistive torque was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Title
Passive resistive torque
Description
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
Time Frame
Passive resistive torque was measured immediately after stretching

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women aged 18-55 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten P Støve, PT. Msc.
Phone
0045 72691004
Email
mps@ucn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Allan Riis, PT. Ph.D.
Phone
+4572691310
Email
alr@ucn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten P Støve, Pt. Msc
Organizational Affiliation
University College of Northern Denmark and Center for General Practice, Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College of Northern Denmark
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Pallisgaard Støve, Msc.
Phone
72691004
Email
mps@ucn.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data is made available upon request.
IPD Sharing Access Criteria
Access is granted on reasonable request

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The Effect of Stretching Intensity on Pain Sensitivity

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