Range of Motion, ArticularNCT04146506
Gender Differences in the Tolerance to Stretch
An observational study of Range of Motion, Articular and Muscle Stretching Exercises, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Range of Motion, Articular, Muscle Stretching Exercises
- What is being tested?
- Muscle stretching exercises
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Nov 2019to 30 Jul 2020
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female volunteers between the ages of 18 to 45 are eligible for participation.
Who may be able to join
- Absence of any pain or other conditions which might affect the somatosensory system and pain perception
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
Official title: The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?
The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.
Read the detailed description
Given that there may be differences in the way men and women perceive a painful stimulus, this suggests that there may be potential gender differences in the tolerance to stretch following stretching.
- Being tested
- Muscle stretching exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle stretching exercisesOther
Muscle stretching exercises consisting of static stretching exercises of the knee flexors
| Study group | Role | What they receive |
|---|---|---|
| Male | Static Muscle stretching exercises of the knee flexors Receives: Other: Muscle stretching exercises | |
| Female | Static Muscle stretching exercises of the knee flexors Receives: Other: Muscle stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Passive knee extension Range of motion
Measured: Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises
Range of Motion
Passive knee extension Range of motion
Measured: Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises
Pain Thresholds
Pressure Pain Thresholds
Measured: Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises
Pain Thresholds
Pressure Pain Thresholds
Measured: Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises
Torque
Passive Resistive Torque
Measured: Passive resistive torque was measured at baseline just prior to muscle stretching exercises
Torque
Passive Resistive Torque
Measured: Passive resistive torque was measured 30 seconds after muscle stretching exercises
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start11 Nov 2019
- Primary completion30 Mar 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Range of Motion, ArticularStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dorte Drachman, Msc., Study director, University College of Northern Denmark, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146506
- Sponsor's protocol ID
- UniversityCND2
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD (range of motion, PPT and Torque data) will be shared upon request
Publications
Stove MP, Hirata RP, Palsson TS. Regional and widespread pain sensitivity decreases following stretching in both men and women - Indications of stretch-induced hypoalgesia. J Bodyw Mov Ther. 2024 Jul;39:32-37. doi: 10.1016/j.jbmt.2024.02.003. Epub 2024 Feb 27.
PubMed 38876646
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stretching on Pain Sensitivity - Potential Gender Differences?
- ClinicalTrials.gov ID
- NCT04146506
- Acronym / sponsor ID
- UniversityCND2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 31 Oct 2019 (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.
The effect of stretching on range of motion is believed to rely upon an increased tolerance to stretch. This suggests, that pain modulation has significance in regards to the effect of stretching.
Detailed description
Given that there may be differences in the way men and women perceive a painful stimulus, this suggests that there may be potential gender differences in the tolerance to stretch following stretching.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Male | – | Other: Muscle stretching exercisesStatic Muscle stretching exercises of the knee flexors |
| Female | – | Other: Muscle stretching exercisesStatic Muscle stretching exercises of the knee flexors |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female volunteers between the ages of 18 to 45 are eligible for participation.
Key inclusion criteria (1 listed)
- Absence of any pain or other conditions which might affect the somatosensory system and pain perception
Key exclusion criteria (1 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 |
|---|---|---|
| Muscle stretching exercisesMuscle stretching exercises consisting of static stretching exercises of the knee flexors | Other | Female, Male |
Primary outcome
Range of Motion
Time frame: Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises
Passive knee extension Range of motion
Range of Motion
Time frame: Passive knee extension range of motion was measured 30 seconds after Muscle stretching exercises
Passive knee extension Range of motion
Pain Thresholds
Time frame: Pressure pain Thresholds were measured at baseline just prior to muscle stretching exercises
Pressure Pain Thresholds
Pain Thresholds
Time frame: Pressure pain Thresholds were measured 30 seconds after muscle stretching exercises
Pressure Pain Thresholds
Torque
Time frame: Passive resistive torque was measured at baseline just prior to muscle stretching exercises
Passive Resistive Torque
Torque
Time frame: Passive resistive torque was measured 30 seconds after muscle stretching exercises
Passive Resistive Torque
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 6 Oct 2020.
- Derived from this study: PubMed 38876646Stove MP, Hirata RP, Palsson TS. Regional and widespread pain sensitivity decreases following stretching in both men and women - Indications of stretch-induced hypoalgesia. J Bodyw Mov Ther. 2024 Jul;39:32-37. doi: 10.1016/j.jbmt.2024.02.003. Epub 2024 Feb 27.
- Individual participant dataSharing planned: No. IPD (range of motion, PPT and Torque data) will be shared upon request
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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?
An observational study of Range of Motion, Articular and Muscle Stretching Exercises, 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 1 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 6 Oct 2020. 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?
Range of Motion (time frame: Passive knee extension range of motion was measured at baseline just prior to Muscle stretching exercises). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04146506, which also lists 1 linked publication.
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 6 Oct 2020.