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Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance

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ClinicalTrials.gov Identifier: NCT03713788
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Morten Pallisgaard, University College of Northern Denmark

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date October 22, 2018
Actual Study Start Date  ICMJE May 1, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Knee extension range of motion [ Time Frame: Passive knee extension range of motion was measured at baseline ]
    Passively induced knee extension range of motion was measured usind the Biodex system 4 pro isokinetic dynomometer
  • Change in knee extension range of motion between baseline and post stretch. [ Time Frame: Changes in passive knee extension range of motion were measured 5 minutes after baseline measures following stretching ]
    Changes in passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynomometer
  • Changes in knee extension range of motion between post stretch and post pain. [ Time Frame: Changes in passive knee extension range of motion were measured 5 minutes after post stretch measures following intervention. ]
    Changes in passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynomometer
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Surface electromyography measures of muscle activity [ Time Frame: Muscle activity during the passive knee extension motion was measured at baseline ]
    Muscle activity during the passive knee extension motion were measured using SEMG.
  • Changes in surface electromyography measures of muscle activity between baseline and post stretch measures. [ Time Frame: Changes in muscle activity during the passive knee extension motion were measured 5 minutes after baseline measures following stretching. ]
    Changes in muscle activity during the passive knee extension motion were measured using SEMG.
  • Changes in surface electromyography measures of muscle activity between post stretch and post pain measures. [ Time Frame: Changes in muscle activity during the passive knee extension motion were measured 5 minutes after post stretch measures following intervention. ]
    Changes in muscle activity during the passive knee extension motion were measured using SEMG.
  • Passive resistive torque using the Biodes system 4 pro. [ Time Frame: Passive resistive torque during the passive knee extension motion was measured at baseline. ]
    Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
  • Changes in passive resistive torque measured using the Biodex system 4 pro between baseline and post stretch measures. [ Time Frame: Changes in passive resistive torque during the passive knee extension motion was measured 5 minutes after baseline measures following stretching. ]
    Changes in passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
  • Changes in passive resistive torque measured using the Biodex system 4 pro between post stretch and post pain measures. [ Time Frame: Passive resistive torque during the passive knee extension motion was measured 5 minutes after post stretch measures following intervention. ]
    Changes in Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance
Official Title  ICMJE Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance
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.
Detailed Description

The effect of stretching on joint range of motion is primarily related to changes in the tolerance to stretch, but the mechanisms underlying this change are still largely unknown.

The nervous system has an inbuilt ability to modulate the perceived magnitude of afferent noxious stimuli via supraspinally mediated endogenous pain inhibition or facilitation and by engaging endogenous mechanisms pain tolerance in healthy individuals is known to increase. Thus increasing the tolerance to pain could potentially increase range of motion following stretching.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Muscle Stretching Exercises
  • Pain Threshold
Intervention  ICMJE Other: Cold pressor test
Participants placed their non-dominant hand into cold water for 2 minutes
Study Arms  ICMJE
  • Experimental: Experimental pain group
    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.
    Intervention: Other: Cold pressor test
  • No Intervention: Control group
    Participants rested in a seated position for 5 minutes.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2016
Actual Primary Completion Date November 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Substance abuse,
  • History of neurological or mental disabilities
  • Lack of ability to comply with instructions
  • Delayed onset of muscle soreness.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Only males were included to avoid the potential effect that fluctuations in gonadal hormone values may have on the endogenous pain inhibitory mechanisms.
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03713788
Other Study ID Numbers  ICMJE UniversityCND
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Morten Pallisgaard, University College of Northern Denmark
Study Sponsor  ICMJE University College of Northern Denmark
Collaborators  ICMJE Aalborg University
Investigators  ICMJE
Study Director: Dorte Drachman, Msc. University College of Northern Denmark, Department of Physiotherapy
PRS Account University College of Northern Denmark
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP