StretchingNCT02027766
Stretching and Pain Sensitivity
A study testing Calf muscle stretching in people with Stretching, run by Marius Henriksen at 1 site in Denmark.
Trial summary
Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and to prevent sports injuries. It is not known if stretching affects pain sensitivity. The purpose of this study is to investigate if a 4 week daily stretching protocol alters pain sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stretching
- What is being tested?
- Calf muscle stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Apr 2014
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40
- In general good health, in the opinion of the Investigator, based on medical and physical history.
- Speaks, reads and writes Danish language.
Who cannot join
- Regular use of stretching
- History of surgery to the lower limb(s)
- History of traumatic and overuse injures to the lower limb(s), including but not limited to: Tendinopathies, Bursitis, Muscle injuries, Significant ankle sprains, other ligament injuries
- Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome
- History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis).
- Planned surgical procedure during the duration of the study
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- History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to: Stroke or transient ischemic attack, Alzheimer's disease or other types of dementia, Clinically significant head trauma within the past year, Peripheral neuropathy, Epilepsy or seizure, Impaired balance
- Alcohol or drug abuse within the last 5 years
- History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
- Diabetes
- Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
- Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
Copenhagen, 2000
About this study
Official title: Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial
Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and to prevent sports injuries. It is not known if stretching affects pain sensitivity. The purpose of this study is to investigate if a 4 week daily stretching protocol alters pain sensitivity.
The investigators hypothesize that stretching reduces pain sensitivity.
- Conditions
- Stretching
- Being tested
- Calf muscle stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calf muscle stretchingOther
| Study group | Role | What they receive |
|---|---|---|
| Stretching | Experimental | Daily stretching of the calf (dominant side; defined as leg used to kick a ball). 2 stretching exercises are performed daily: 1) stretching of the soleus muscle; 2) stretching of the gastrocnemius muscle. Receives: Other: Calf muscle stretching |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer
Measured: Baseline and after 4 weeks
Secondary outcomes (3)
Change from baseline in PPT at the counter lateral calf
Measured: Baseline and 4 weeks
Change from baseline in PPT at the ipsilateral arm
Measured: baseline and 4 weeks
Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.
Measured: Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StretchingStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Marius Henriksen, PT, PhD, Principal investigator, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027766
- Sponsor's protocol ID
- 129
- Status last verified
- May 2014
- First submitted
- 3 Jan 2014
- Last updated
- 6 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial
- ClinicalTrials.gov ID
- NCT02027766
- Acronym / sponsor ID
- 129
- Conditions
- Stretching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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.
Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and to prevent sports injuries. It is not known if stretching affects pain sensitivity. The purpose of this study is to investigate if a 4 week daily stretching protocol alters pain sensitivity.
The investigators hypothesize that stretching reduces pain sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching | Experimental | Other: Calf muscle stretchingDaily stretching of the calf (dominant side; defined as leg used to kick a ball). 2 stretching exercises are performed daily: 1) stretching of the soleus muscle; 2) stretching of the gastrocnemius muscle. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged between 18 and 40
- In general good health, in the opinion of the Investigator, based on medical and physical history.
- Speaks, reads and writes Danish language.
Key exclusion criteria (12 listed)
- Regular use of stretching
- History of surgery to the lower limb(s)
- History of traumatic and overuse injures to the lower limb(s), including but not limited to: Tendinopathies, Bursitis, Muscle injuries, Significant ankle sprains, other ligament injuries
- Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome
- History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis).
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 |
|---|---|---|
| Calf muscle stretching | Other | Stretching |
Primary outcome
Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer
Time frame: Baseline and after 4 weeks
3 secondary outcomes
Change from baseline in PPT at the counter lateral calf
Time frame: Baseline and 4 weeks
Change from baseline in PPT at the ipsilateral arm
Time frame: baseline and 4 weeks
Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.
Time frame: Baseline and after 4 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 6 May 2014.
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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.
Marius Henriksen, PT, PhD principal investigator
Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calf muscle stretching in people with Stretching, run by Marius Henriksen 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 3 inclusion and 12 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 May 2014. 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?
Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer (time frame: Baseline and after 4 weeks). 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 6 May 2014.