Pain ThresholdNCT03886883
Endogenous Modulation of Pain and Stretch Tolerance
A study testing Exercise induced hypoalgesia (EIH), Static stretch (SS) and Rest in people with Pain Threshold, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study. 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
- Pain Threshold
- What is being tested?
- Exercise induced hypoalgesia (EIH), Static stretch (SS) and Rest
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 30 Dec 2017
- 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
Official title: Endogenous Modulation of Pain - the Tolerance to Stretch
This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study.
Read the detailed description
The increase in range of motion following stretching is related to changes in the tolerance to stretch. The mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.
- Conditions
- Pain Threshold
- Being tested
- Exercise induced hypoalgesia (EIH), Static stretch (SS), Rest, Conditioned pain modulation (CPM)
- Keywords
- Stretch tolerance, Stretching Exercises, Exercise induced hypoalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise induced hypoalgesia (EIH)Other
An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).
Static stretch (SS)Other
Two bouts of 30 seconds of static stretching (SS) of the knee flexors.
RestOther
The participants rested in a seated position for 10 minutes
Conditioned pain modulation (CPM)Other
A CPM response was induced by way of the cold pressor test.
| Study group | Role | What they receive |
|---|---|---|
| Exercise-induced hypoalgesia (EIH) | Experimental | Exercise-induced hypoalgesia - isometric muscle contractions of the hand flexors Receives: Other: Exercise induced hypoalgesia (EIH) |
| Static stretch (SS) | Active comparator | A static stretch of the knee flexors Receives: Other: Static stretch (SS) |
| Rest | Sham comparator | No intervention Receives: Other: Rest |
| Conditioning painful stimulus (CPM) | Experimental | Conditioned pain modulation - cold pressure test Receives: Other: Conditioned pain modulation (CPM) |
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 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 exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
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 30 seconds after the induction of EIH, SS, Rest and CPM
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 10 minutes after the induction of EIH, SS, Rest and CPM
Secondary outcomes (6)
Passive resistive torque
Passive resistive torque during the passive knee extension motion 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 EIH, SS, Rest and CPM
Passive resistive torque
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Measured: Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passive resistive torque
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
Measured: Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Measured: Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Measured: Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
PRessure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
Measured: Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Oct 2017
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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
- Randomised
- Intervention model
- Crossover
- Model description
- This was a randomized, repeated-measures cross-over study. 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. Pressure pain thresholds was assessed using a handheld pressure algometer (Somedic AB, Hörby, Sweden).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 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
- NCT03886883
- Sponsor's protocol ID
- UniversityCND1
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stove MP, Hirata RP, Palsson TS. The tolerance to stretch is linked with endogenous modulation of pain. Scand J Pain. 2021 Jan 11;21(2):355-363. doi: 10.1515/sjpain-2020-0010. Print 2021 Apr 27.
PubMed 34387949
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endogenous Modulation of Pain - the Tolerance to Stretch
- ClinicalTrials.gov ID
- NCT03886883
- Acronym / sponsor ID
- UniversityCND1
- Conditions
- Pain Threshold
- Keywords
- Stretch tolerance, Stretching Exercises, Exercise induced hypoalgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 22 Mar 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.
This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity. The study is a randomized, repeated-measures cross-over study.
Detailed description
The increase in range of motion following stretching is related to changes in the tolerance to stretch. The mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This was a randomized, repeated-measures cross-over study. 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. Pressure pain thresholds was assessed using a handheld pressure algometer (Somedic AB, Hörby, Sweden).
| Arm | Type | Receives |
|---|---|---|
| Exercise-induced hypoalgesia (EIH) | Experimental | Other: Exercise induced hypoalgesia (EIH)Exercise-induced hypoalgesia - isometric muscle contractions of the hand flexors |
| Static stretch (SS) | Active comparator | Other: Static stretch (SS)A static stretch of the knee flexors |
| Rest | Sham comparator | Other: RestNo intervention |
| Conditioning painful stimulus (CPM) | Experimental | Other: Conditioned pain modulation (CPM)Conditioned pain modulation - cold pressure test |
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 (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 |
|---|---|---|
| Exercise induced hypoalgesia (EIH)An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC). | Other | Exercise-induced hypoalgesia (EIH) |
| Static stretch (SS)Two bouts of 30 seconds of static stretching (SS) of the knee flexors. | Other | Static stretch (SS) |
| RestThe participants rested in a seated position for 10 minutes | Other | Rest |
| Conditioned pain modulation (CPM)A CPM response was induced by way of the cold pressor test. | Other | Conditioning painful stimulus (CPM) |
Primary outcome
Knee extension range of motion
Time frame: Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Knee extension range of motion
Time frame: Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
Knee extension range of motion
Time frame: Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
6 secondary outcomes
Passive resistive torque
Time frame: Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Passive resistive torque
Time frame: Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
Passive resistive torque
Time frame: Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM
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 26 Mar 2019.
- Derived from this study: PubMed 34387949Stove MP, Hirata RP, Palsson TS. The tolerance to stretch is linked with endogenous modulation of pain. Scand J Pain. 2021 Jan 11;21(2):355-363. doi: 10.1515/sjpain-2020-0010. Print 2021 Apr 27.
- Individual participant dataSharing planned: No
Related trials for Pain Threshold
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Recruiting
IASTM vs. Static Stretching for Hamstring Tightness: Short- and Long-Term Effects
Hamstring Tightness
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Active, not recruitingObservational study
Neuropathic Hand Pain in Rheumatoid Arthritis
Rheumatoid Arthritis
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 Exercise induced hypoalgesia (EIH), Static stretch (SS) and Rest 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 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 26 Mar 2019. 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. Some participants in this study may receive a placebo. 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 as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)). 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 NCT03886883, 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 26 Mar 2019.