NCT04919681

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

June 1, 2021

Last Update Submit

April 19, 2023

Conditions

Keywords

StretchingPain sensitivityRange of motionExercise adherence

Outcome Measures

Primary Outcomes (3)

  • Pain sensitivity

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

    Baseline

  • Pain sensitivity

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

    6 weeks

  • 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 Outcomes (6)

  • Range of motion

    Baseline

  • Range of motion

    6 weeks

  • Range of motion

    10 weeks

  • Passive resistive torque

    Baseline

  • Passive resistive torque

    6 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Adherence to the stretching protocol

    6 weeks

Study Arms (1)

Stretching

EXPERIMENTAL

Static stretching of the knee flexors

Other: Stretch exercises

Interventions

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.

Stretching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College of Northern Denmark

Aalborg, 9220, Denmark

Location

Related Publications (1)

  • Stove MP, Thomsen JL, Magnusson SP, Riis A. The effect of six-week regular stretching exercises on regional and distant pain sensitivity: an experimental longitudinal study on healthy adults. BMC Sports Sci Med Rehabil. 2024 Sep 27;16(1):202. doi: 10.1186/s13102-024-00995-2.

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dorte Drachmann, Msc.

    Department of Physiotherapy, University College of Northern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single-blind longitudinal repeated measures study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Lecturer

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 9, 2021

Study Start

November 4, 2021

Primary Completion

April 25, 2022

Study Completion

October 20, 2022

Last Updated

April 20, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Data is made available upon request.

Shared Documents
STUDY PROTOCOL
Time Frame
Study protocol will be published
Access Criteria
The study protocol will be published open access

Locations