NCT03713788

Brief Summary

This study investigates the influence of a remote, painful stimulus on stretch tolerance. Half of the participants will receive a conditioning painful stimulus following static stretching while the other half will rest quietly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

October 15, 2018

Last Update Submit

October 19, 2018

Conditions

Keywords

Stretch toleranceRange of Motion

Outcome Measures

Primary Outcomes (3)

  • Knee extension range of motion

    Passively induced knee extension range of motion was measured usind the Biodex system 4 pro isokinetic dynomometer

    Passive knee extension range of motion was measured at baseline

  • Change in knee extension range of motion between baseline and post stretch.

    Changes in passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynomometer

    Changes in passive knee extension range of motion were measured 5 minutes after baseline measures following stretching

  • Changes in knee extension range of motion between post stretch and post pain.

    Changes in passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynomometer

    Changes in passive knee extension range of motion were measured 5 minutes after post stretch measures following intervention.

Secondary Outcomes (6)

  • Surface electromyography measures of muscle activity

    Muscle activity during the passive knee extension motion was measured at baseline

  • Changes in surface electromyography measures of muscle activity between baseline and post stretch measures.

    Changes in muscle activity during the passive knee extension motion were measured 5 minutes after baseline measures following stretching.

  • Changes in surface electromyography measures of muscle activity between post stretch and post pain measures.

    Changes in muscle activity during the passive knee extension motion were measured 5 minutes after post stretch measures following intervention.

  • Passive resistive torque using the Biodes system 4 pro.

    Passive resistive torque during the passive knee extension motion was measured at baseline.

  • Changes in passive resistive torque measured using the Biodex system 4 pro between baseline and post stretch measures.

    Changes in passive resistive torque during the passive knee extension motion was measured 5 minutes after baseline measures following stretching.

  • +1 more secondary outcomes

Study Arms (2)

Experimental pain group

EXPERIMENTAL

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. They were instructed to immerse it to wrist-level and keep the hand open.

Other: Cold pressor test

Control group

NO INTERVENTION

Participants rested in a seated position for 5 minutes.

Interventions

Participants placed their non-dominant hand into cold water for 2 minutes

Experimental pain group

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

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
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A sample of convenience was recruited for this cross-sectional study. Participants were randomly assigned to a pain group or a control group using counterbalanced block randomization. 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. Muscle activity was recorded as surface electromyography.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior associate lecturer

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 22, 2018

Study Start

May 1, 2016

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations