Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2026-01-01 @ 4:47 PM
Study NCT ID:
NCT07031193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Instructional Influence: How Cueing Alters Foam Rolling Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-06-12', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Straight leg raise Range of motion on dominate leg', 'timeFrame': 'from enrollment to the end of the session at 1 day', 'description': 'Hamstring range of motion is measured with a standard goniometer on the dominant leg (the leg you would prefer to kick a ball with). Participant lying supine, the examiner assists with raising the leg straight (knee at 0 degrees extension) at the hip into flexion. Measure maximal hip flexion, with no change in knee extension, posterior pelvic tilt, or lumbar spine flexion. Goniometric measurements of hamstring length will then be measured with the stationary arm in line with the lateral midline of the pelvis, the axis of the goniometer will be placed on the greater trochanter of the hip, and the movement arm will be lined up with the midline of the lateral femur to the lateral epicondyle of the ipsilateral knee.'}, {'measure': 'Pain pressure threshold of the hamstring muscle group', 'timeFrame': 'from enrollment to the end of the session at 1 day', 'description': 'Use of a handheld algometer to assess pain pressure threshold. Application of pressure at the middle point of the hamstring on the dominant leg (the leg you would prefer to kick a ball with). The middle point is determined by the midway point measured from the ischial tuberosity and the knee joint line. Pressure is applied at a steady rate until the participant reports that the sensation of pressure changes from pressure to pain. Measurement in kg/cm2 will be recorded and the average of three measurements will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['foam roller,', 'range of motion', 'pain'], 'conditions': ['Foam Roller']}, 'descriptionModule': {'briefSummary': 'Foam rolling (FR) is a common tool and procedure used in rehabilitation. Previous research has demonstrated physical improvements in range of motion and subjective reductions in pain post-intervention. Most of the literature theorizes potential biophysical reasons for these changes, but definitive studies are lacking. Another potential mechanism for these improvements may be psychological.\n\nThe purpose of this study is to explore the psychological changes that occur in response to the instructions given to the patient and how these may influence the outcomes the individual receives while undergoing FR.\n\nDifferent instructions will be given for the same technique of FR to see if there are differences in changes with pain and range of motion.', 'detailedDescription': 'Participants will receive one set of instructions that highlights the pain relieving properties of FR, while the other group will receive instructions on ability of FR to improve range of motion. Participants will be measured for range of motion and pain changes in both groups pre and post instruction and performing the identical technique of FR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fluent in English and primary language\n\nExclusion Criteria:\n\n* Current musculoskeletal injury of the lower limbs for which they are receiving medical care.\n* Recent surgery to the lower limbs that has not been fully released for full participation by a medical provider.\n* Use of any pain-relieving medications within the last 24 hours.\n* Any medical condition that limits their perception of pain.'}, 'identificationModule': {'nctId': 'NCT07031193', 'briefTitle': 'Instructional Influence: How Cueing Alters Foam Rolling Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of South Dakota'}, 'officialTitle': 'Instructional Influence: How Cueing Alters Foam Rolling Outcomes', 'orgStudyIdInfo': {'id': 'IRB-25-143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ROM', 'description': 'Foam rolling with instructions related to pain reduction', 'interventionNames': ['Procedure: Foam roller instructions for pain reduction', 'Procedure: Foam rolling for range of motion improvement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain', 'description': 'Foam rolling with Pain reduction instructions', 'interventionNames': ['Procedure: Foam roller instructions for pain reduction', 'Procedure: Foam rolling for range of motion improvement']}], 'interventions': [{'name': 'Foam roller instructions for pain reduction', 'type': 'PROCEDURE', 'description': 'Foam rolling procedure with pain reduction instructions over hamstring muscle group', 'armGroupLabels': ['Pain', 'ROM']}, {'name': 'Foam rolling for range of motion improvement', 'type': 'PROCEDURE', 'description': 'Foam rolling over hamstring muscle group with range of motion improvement instructions.', 'armGroupLabels': ['Pain', 'ROM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57069', 'city': 'Vermillion', 'state': 'South Dakota', 'country': 'United States', 'contacts': [{'name': 'Kory', 'role': 'CONTACT', 'email': 'kory.zimney@usd.edu', 'phone': '6056586373'}], 'facility': 'University of South Dakota', 'geoPoint': {'lat': 42.77944, 'lon': -96.92921}}], 'centralContacts': [{'name': 'Kory Zimney, DPT, PhD', 'role': 'CONTACT', 'email': 'kory.zimney@usd.edu', 'phone': '877-269-6837', 'phoneExt': '605-658-6373'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Dakota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kory Zimney, PT, DPT, PhD', 'investigatorAffiliation': 'University of South Dakota'}}}}