Pain ThresholdNCT05989490
The Effect of Stretching Intensity on Pain Sensitivity
A study testing Static stretching in people with Pain Threshold and Stretching, 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 stretching intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized that the analgesic effect of stretching may be linked with the intensity of stretching in a dose-response relationship. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Threshold, Stretching, Pain Sensitivity
- What is being tested?
- Static stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2023to 30 Apr 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women aged 18-55 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the immediate efficiency of stretching intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized that the analgesic effect of stretching may be linked with the intensity of stretching in a dose-response relationship.
- Conditions
- Pain Threshold, Stretching, Pain Sensitivity, Range of Motion
- Being tested
- Static stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static stretchingOther
The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort and to the point of pain.
| Study group | Role | What they receive |
|---|---|---|
| Static stretching to the point of pain | Experimental | The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain. Receives: Other: Static stretching |
| Static stretching to the point of discomfort | Experimental | The participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort. Receives: Other: Static stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer
Measured: Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer
Measured: Pressure pain thresholds were measured immediately after stretching
Secondary outcomes (4)
Knee extension range of motion
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Measured: Passive knee extension range of motion was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Knee extension range of motion
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Measured: Passive knee extension range of motion was measured immediately after stretching
Passive resistive torque
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
Measured: Passive resistive torque was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Passive resistive torque
Passive resistive torque was measured using the Biodex system 4 pro isokinetic dynamometer
Measured: Passive resistive torque was measured immediately after stretching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Aug 2023
- Primary completion30 Nov 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- This was a randomized, repeated-measures cross-over study. The interventions consist of two different stretching protocols (e.g., stretching to the point of discomfort and stretching to the point of pain). Subjects were randomized to one of two groups (pain first or discomfort first). Both groups underwent a static stretch protocol consisting of four bouts of thirty-second constant-angle static stretching of the knee flexors with a 20-second rest period between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension to the point of discomfort and the point of pain.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 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
- Sponsor
- Investigators
- Morten P Støve, Pt. Msc, Principal investigator, University College of Northern Denmark and Center for General Practice, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989490
- Sponsor's protocol ID
- Intensity vs. Hypoalgesia
- Status last verified
- Apr 2024
- First submitted
- 2 Jul 2023
- Last updated
- 9 May 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stretching Intensity on Pain Sensitivity
- ClinicalTrials.gov ID
- NCT05989490
- Acronym / sponsor ID
- Intensity vs. Hypoalgesia
- Conditions
- Pain Threshold, Stretching, Pain Sensitivity, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 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
- 20 Aug 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Aug 2023 (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 stretching intensity on regional and distant pain sensitivity in healthy subjects. It is hypothesized that the analgesic effect of stretching may be linked with the intensity of stretching in a dose-response relationship.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This was a randomized, repeated-measures cross-over study. The interventions consist of two different stretching protocols (e.g., stretching to the point of discomfort and stretching to the point of pain). Subjects were randomized to one of two groups (pain first or discomfort first). Both groups underwent a static stretch protocol consisting of four bouts of thirty-second constant-angle static stretching of the knee flexors with a 20-second rest period between bouts. Subjects were instructed to keep the limb relaxed as the lower leg was passively moved towards extension to the point of discomfort and the point of pain.
| Arm | Type | Receives |
|---|---|---|
| Static stretching to the point of pain | Experimental | Other: Static stretchingThe participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of pain. |
| Static stretching to the point of discomfort | Experimental | Other: Static stretchingThe participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy men and women aged 18-55 years are recruited. As part of the screening, volunteers will also be asked to indicate known medical issues or diseases.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Static stretchingThe participants are assigned to four bouts of static stretching of the right knee flexors with a 20-second rest period between bouts 20 to the point of discomfort and to the point of pain. | Other | Static stretching to the point of discomfort, Static stretching to the point of pain |
Primary outcome
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Pressure pain thresholds was measures using a handheld pressure algometer
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured immediately after stretching
Pressure pain thresholds was measures using a handheld pressure algometer
4 secondary outcomes
Knee extension range of motion
Time frame: Passive knee extension range of motion was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Knee extension range of motion
Time frame: Passive knee extension range of motion was measured immediately after stretching
Passive resistive torque
Time frame: Passive resistive torque was measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort
Passive resistive torque
Time frame: Passive resistive torque was measured immediately after stretching
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 9 May 2024.
- Individual participant dataSharing planned: Yes. Data is made available upon request.
Related trials for Pain Threshold
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Recruiting
IASTM vs. Static Stretching for Hamstring Tightness: Short- and Long-Term Effects
Hamstring Tightness
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.
Morten P Støve, Pt. Msc principal investigator
University College of Northern Denmark and Center for General Practice, Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static stretching in people with Pain Threshold and Stretching, 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 9 May 2024. 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?
Pressure pain thresholds (time frame: Pressure pain thresholds were measured as a baseline just prior to the induction of stretching to the point of pain and stretching to the point of discomfort). The study lists 2 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 9 May 2024.