Clinical trial NCT02027766: Stretching and Pain Sensitivity
Official title: Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stretching
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pressure pain threshold (PPT) at the ipsilateral (same side as being stretched) calf assessed by a cuff pressure algometer
timeFrame: Baseline and after 4 weeks
Secondary outcomes:
measure: Change from baseline in PPT at the counter lateral calf
timeFrame: Baseline and 4 weeks
measure: Change from baseline in PPT at the ipsilateral arm
timeFrame: baseline and 4 weeks
measure: Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm.
timeFrame: Baseline and after 4 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Bispebjerg and Frederiksberg University Hospitals
Study officials:
affiliation: Frederiksberg Hospital
name: Marius Henriksen, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: