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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02027766
Other study ID # 129
Secondary ID
Status Completed
Phase N/A
First received January 3, 2014
Last updated May 5, 2014
Start date January 2014
Est. completion date April 2014

Study information

Verified date May 2014
Source Frederiksberg University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical 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.

The investigators hypothesize that stretching reduces pain sensitivity.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Calf muscle stretching


Locations

Country Name City State
Denmark The Parker Institute, Bispebjerg and Frederiksberg University Hospitals Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Change from baseline in PPT at the counter lateral calf Baseline and 4 weeks No
Secondary Change from baseline in PPT at the ipsilateral arm baseline and 4 weeks No
Secondary Change from baseline in temporal summation of pressure pain at both calfs and ipsilateral arm. Baseline and after 4 weeks No
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