NCT03886883

Brief Summary

This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

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

Study Start

First participant enrolled

October 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

March 13, 2019

Last Update Submit

March 22, 2019

Conditions

Keywords

Stretch toleranceStretching ExercisesExercise induced hypoalgesia

Outcome Measures

Primary Outcomes (3)

  • Knee extension range of motion

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

    Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)

  • Knee extension range of motion

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

    Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM

  • Knee extension range of motion

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

    Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM

Secondary Outcomes (6)

  • Passive resistive torque

    Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM

  • Passive resistive torque

    Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM

  • Passive resistive torque

    Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM

  • Pressure pain thresholds

    Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM

  • Pressure pain thresholds

    Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM

  • +1 more secondary outcomes

Study Arms (4)

Exercise-induced hypoalgesia (EIH)

EXPERIMENTAL

Exercise-induced hypoalgesia - isometric muscle contractions of the hand flexors

Other: Exercise induced hypoalgesia (EIH)

Static stretch (SS)

ACTIVE COMPARATOR

A static stretch of the knee flexors

Other: Static stretch (SS)

Rest

SHAM COMPARATOR

No intervention

Other: Rest

Conditioning painful stimulus (CPM)

EXPERIMENTAL

Conditioned pain modulation - cold pressure test

Other: Conditioned pain modulation (CPM)

Interventions

An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).

Exercise-induced hypoalgesia (EIH)

Two bouts of 30 seconds of static stretching (SS) of the knee flexors.

Static stretch (SS)
RestOTHER

The participants rested in a seated position for 10 minutes

Rest

A CPM response was induced by way of the cold pressor test.

Conditioning painful stimulus (CPM)

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males were included to avoid the potential effect that fluctuations in gonadal hormone values may have on the endogenous pain inhibitory mechanisms.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.

You may not qualify if:

  • Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness.

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, Hirata RP, Palsson TS. The tolerance to stretch is linked with endogenous modulation of pain. Scand J Pain. 2021 Jan 11;21(2):355-363. doi: 10.1515/sjpain-2020-0010. Print 2021 Apr 27.

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

  • Dorte Drachman, Msc.

    University College of Northern Denmark, Department of Physiotherapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to the results of all measurements and naïve to research hypotheses.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: This was a randomized, repeated-measures cross-over study. Passive knee extension range of motion was measured three consecutive times with five-minute intervals between measurements. Both groups underwent a static stretch protocol consisting of two bouts of thirty-second constant-angle static stretching of the knee flexors with a one-minute rest between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension. Following stretching, the post-stretch measurement was performed. Finally, subjects in the pain group were instructed to immerse their non-dominant hand into a container with circulating water at 1˚C to 4˚C and keep it there for 2 minutes. A Biodex system 4 pro dynamometer was used to quantify range of motion and passive resistive torque. Pressure pain thresholds was assessed using a handheld pressure algometer (Somedic AB, Hörby, Sweden).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 22, 2019

Study Start

October 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations