Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT02027766
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stretching and Pain Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-05', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'conditions': ['Stretching']}, 'descriptionModule': {'briefSummary': '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.\n\nThe investigators hypothesize that stretching reduces pain sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 18 and 40\n* In general good health, in the opinion of the Investigator, based on medical and physical history.\n* Speaks, reads and writes Danish language.\n\nExclusion Criteria:\n\n* Regular use of stretching\n* History of surgery to the lower limb(s)\n* 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\n* Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome\n* History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis).\n* Planned surgical procedure during the duration of the study\n* 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\n* Alcohol or drug abuse within the last 5 years\n* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder\n* Diabetes\n* Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.\n* 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."}, 'identificationModule': {'nctId': 'NCT02027766', 'briefTitle': 'Stretching and Pain Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Frederiksberg University Hospital'}, 'officialTitle': 'Local and Systemic Changes in Pain Sensitivity After 4 Weeks of Calf Muscle-tendon Stretching: A Randomised Trial', 'orgStudyIdInfo': {'id': '129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stretching', 'description': '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.', 'interventionNames': ['Other: Calf muscle stretching']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Calf muscle stretching', 'type': 'OTHER', 'armGroupLabels': ['Stretching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'The Parker Institute, Bispebjerg and Frederiksberg University Hospitals', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Marius Henriksen, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frederiksberg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marius Henriksen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher', 'investigatorFullName': 'Marius Henriksen', 'investigatorAffiliation': 'Frederiksberg University Hospital'}}}}