- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027766
Stretching and Pain Sensitivity
May 5, 2014 updated by: Marius Henriksen
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2000
- The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
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Experimental: Stretching
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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Baseline and after 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change from baseline in PPT at the counter lateral calf
Time Frame: Baseline and 4 weeks
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Baseline and 4 weeks
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Change from baseline in PPT at the ipsilateral arm
Time Frame: baseline and 4 weeks
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baseline and 4 weeks
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Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.
Time Frame: Baseline and after 4 weeks
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Baseline and after 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marius Henriksen, PT, PhD, Frederiksberg Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
January 3, 2014
First Submitted That Met QC Criteria
January 3, 2014
First Posted (Estimate)
January 6, 2014
Study Record Updates
Last Update Posted (Estimate)
May 6, 2014
Last Update Submitted That Met QC Criteria
May 5, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 129
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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