NCT05989490

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

May 9, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

July 2, 2023

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pressure pain thresholds

    Pressure pain thresholds was measures using a handheld pressure algometer

    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

  • Pressure pain thresholds

    Pressure pain thresholds was measures using a handheld pressure algometer

    Pressure pain thresholds were measured immediately after stretching

Secondary Outcomes (4)

  • Knee extension range of motion

    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

  • Knee extension range of motion

    Passive knee extension range of motion was measured immediately after stretching

  • Passive resistive torque

    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

  • Passive resistive torque

    Passive resistive torque was measured immediately after stretching

Study Arms (2)

Static stretching to the point of pain

EXPERIMENTAL

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.

Other: Static stretching

Static stretching to the point of discomfort

EXPERIMENTAL

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.

Other: Static stretching

Interventions

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.

Static stretching to the point of discomfortStatic stretching to the point of pain

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College of Northern Denmark

Aalborg, 9220, Denmark

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Morten P Støve, Pt. Msc

    University College of Northern Denmark and Center for General Practice, Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants were blinded to the results of all measurements and naïve to research hypotheses. The investigator was blinded to the results of all measurements.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2023

First Posted

August 14, 2023

Study Start

August 20, 2023

Primary Completion

November 30, 2023

Study Completion

April 30, 2024

Last Updated

May 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Data is made available upon request.

Access Criteria
Access is granted on reasonable request

Locations