Stretching and Pain Sensitivity
Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial
1 other identifier
interventional
40
1 country
1
Brief 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. The investigators hypothesize that stretching reduces pain sensitivity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 3, 2014
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMay 6, 2014
May 1, 2014
3 months
January 3, 2014
May 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer
Baseline and after 4 weeks
Secondary Outcomes (3)
Change from baseline in PPT at the counter lateral calf
Baseline and 4 weeks
Change from baseline in PPT at the ipsilateral arm
baseline and 4 weeks
Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.
Baseline and after 4 weeks
Study Arms (2)
Stretching
EXPERIMENTALDaily 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 INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marius Henriksenlead
Study Sites (1)
The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
Copenhagen, 2000, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Marius Henriksen, PT, PhD
Frederiksberg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
January 3, 2014
First Posted
January 6, 2014
Study Start
January 1, 2014
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 6, 2014
Record last verified: 2014-05