Muscle Stretching ExercisesNCT03713788
Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance
A study testing Cold pressor test in people with Muscle Stretching Exercises and Pain Threshold, run by University College of Northern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Stretching Exercises, Pain Threshold
- What is being tested?
- Cold pressor test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2016to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.
Who cannot join
- Substance abuse,
- History of neurological or mental disabilities
- Lack of ability to comply with instructions
- Delayed onset of muscle soreness.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Stretching Exercises, Pain Threshold
- Being tested
- Cold pressor test
- Keywords
- Stretch tolerance, Range of Motion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pressor testOther
Participants placed their non-dominant hand into cold water for 2 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cold pressor test |
| Control group | No intervention | Participants rested in a seated position for 5 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extension range of motion
Passively induced knee extension range of motion was measured usind the Biodex system 4 pro isokinetic dynomometer
Measured: 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
Measured: 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
Measured: 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 were measured using SEMG.
Measured: 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 using SEMG.
Measured: 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 using SEMG.
Measured: 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 using the Biodex system 4 pro isokinetic dynamometer.
Measured: 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 using the Biodex system 4 pro isokinetic dynamometer.
Measured: 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 measured using the Biodex system 4 pro between post stretch and post pain measures.
Changes in Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Measured: Passive resistive torque during the passive knee extension motion was measured 5 minutes after post stretch measures following intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 May 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Stretching ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Principal investigator, Morten Pallisgaard, University College of Northern Denmark
- Investigators
- Dorte Drachman, Msc., Study director, University College of Northern Denmark, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713788
- Sponsor's protocol ID
- UniversityCND
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Stretching - the Potential Role of Endogenous Pain Inhibitory Modulation on Stretch Tolerance
- ClinicalTrials.gov ID
- NCT03713788
- Acronym / sponsor ID
- UniversityCND
- Conditions
- Muscle Stretching Exercises, Pain Threshold
- Keywords
- Stretch tolerance, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental pain group | Experimental | Other: Cold pressor testsubjects 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. |
| Control group | No intervention | –Participants rested in a seated position for 5 minutes. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.
Key exclusion criteria (4 listed)
- Substance abuse,
- History of neurological or mental disabilities
- Lack of ability to comply with instructions
- Delayed onset of muscle soreness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold pressor testParticipants placed their non-dominant hand into cold water for 2 minutes | Other | Experimental pain group |
Primary outcome
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
6 secondary outcomes
Surface electromyography measures of muscle activity
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorte Drachman, Msc. study director
University College of Northern Denmark, Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pressor test in people with Muscle Stretching Exercises and Pain Threshold, run by University College of Northern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee extension range of motion (time frame: Passive knee extension range of motion was measured at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.