Pain ThresholdNCT04919681
Efficacy of Stretching on Pain Sensitivity
A study testing Stretch exercises in people with Pain Threshold, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold
- What is being tested?
- Stretch exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Nov 2021to 20 Oct 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as
- cognitive impairments,
- neurological,
- orthopaedic,
- or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.
Who cannot join
- Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)
- or use any medication that might affect the somatosensory system, such as pain medication, are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
The primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.
The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.
- Conditions
- Pain Threshold
- Being tested
- Stretch exercises
- Keywords
- Stretching, Pain sensitivity, Range of motion, Exercise adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretch exercisesOther
The intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors. Stretches are performed seated on the ground. The participant sits upright on the floor with one leg straight. The sole of the other foot should be placed on the inside of the outstretched leg. The participant leans slightly forward, trying to touch their toes while maintaining full knee extension. Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Stretching | Experimental | Static stretching of the knee flexors Receives: Other: Stretch exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Measured: Baseline
Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Measured: 6 weeks
Pain sensitivity
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Measured: 10 weeks
Secondary outcomes (6)
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Measured: Baseline
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Measured: 6 weeks
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Measured: 10 weeks
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Measured: Baseline
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Measured: 6 weeks
Passive resistive torque
Passive resistive torque measured in passive kne extension measured by the Biodex system 4 pro isokinetic dynamometer
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start4 Nov 2021
- Primary completion25 Apr 2022
- Study completion20 Oct 2022
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 Pain ThresholdStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-blind longitudinal repeated measures study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Research Unit for General Practice in Aalborg
- Responsible party
- Principal investigator, Morten Pallisgaard, University College of Northern Denmark
- Investigators
- Dorte Drachmann, Msc., Study director, Department of Physiotherapy, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919681
- Sponsor's protocol ID
- UniversityCND3
- Status last verified
- Apr 2023
- First submitted
- 1 Jun 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is made available upon request.
Publications
Stove MP, Thomsen JL, Magnusson SP, Riis A. The effect of six-week regular stretching exercises on regional and distant pain sensitivity: an experimental longitudinal study on healthy adults. BMC Sports Sci Med Rehabil. 2024 Sep 27;16(1):202. doi: 10.1186/s13102-024-00995-2.
PubMed 39334218
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Stretching Protocol on Regional and Distant Pain Sensitivity:
- ClinicalTrials.gov ID
- NCT04919681
- Acronym / sponsor ID
- UniversityCND3
- Conditions
- Pain Threshold
- Keywords
- Stretching, Pain sensitivity, Range of motion, Exercise adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Research Unit for General Practice in Aalborg
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 9 Jun 2021 (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 primary objective of this study is to determine the immediate efficiency of a six weeks regular stretching protocol on regional and distant pain sensitivity. It is hypothesised that regional and distant pain sensitivity will significantly decrease following six weeks of regular stretching.
The secondary objective of the study is to determine the effect after four-week cessation of the stretching protocol on regional and distant pain sensitivity. If regional and distant pain sensitivity decrease following regular stretching, it is hypothesised that the analgesic effect will abate following four-week cessation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-blind longitudinal repeated measures study
| Arm | Type | Receives |
|---|---|---|
| Stretching | Experimental | Other: Stretch exercisesStatic stretching of the knee flexors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy men and women aged 18-65 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases. Participants are included if they have no known medical conditions such as
- cognitive impairments,
- neurological,
- orthopaedic,
- or neuromuscular problems that might affect the somatosensory system or preclude stretching exercises or range of motion testing at the knee.
Key exclusion criteria (2 listed)
- Individuals who regularly engage in flexibility training (e.g., stretching, tai chi, pilates or yoga)
- or use any medication that might affect the somatosensory system, such as pain medication, are excluded.
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 |
|---|---|---|
| Stretch exercisesThe intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors. Stretches are performed seated on the ground. The participant sits upright on the floor with one leg straight. The sole of the other foot should be placed on the inside of the outstretched leg. The participant leans slightly forward, trying to touch their toes while maintaining full knee extension. Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions. | Other | Stretching |
Primary outcome
Pain sensitivity
Time frame: Baseline
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Pain sensitivity
Time frame: 6 weeks
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
Pain sensitivity
Time frame: 10 weeks
The primary outcome is pain sensitivity expressed as regional and distant pressure pain thresholds measured by a handheld pressure algometer
6 secondary outcomes
Range of motion
Time frame: Baseline
Range of motion
Time frame: 6 weeks
Range of motion
Time frame: 10 weeks
Passive resistive torque
Time frame: Baseline
Passive resistive torque
Time frame: 6 weeks
Passive resistive torque
Time frame: 10 weeks
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 20 Apr 2023.
- Derived from this study: PubMed 39334218Stove MP, Thomsen JL, Magnusson SP, Riis A. The effect of six-week regular stretching exercises on regional and distant pain sensitivity: an experimental longitudinal study on healthy adults. BMC Sports Sci Med Rehabil. 2024 Sep 27;16(1):202. doi: 10.1186/s13102-024-00995-2.
- Individual participant dataSharing planned: Yes. Data is made available 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 Drachmann, Msc. study director
Department of Physiotherapy, University College of Northern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretch exercises in people with 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 5 inclusion and 2 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 20 Apr 2023. 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?
Pain sensitivity (time frame: 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?
On the ClinicalTrials.gov record for NCT04919681, 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 20 Apr 2023.