Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 2:31 AM
Study NCT ID:
NCT05236933
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2022-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Types of Pain and Motor Activities Physical Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-10', 'studyFirstSubmitDate': '2022-01-19', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity over 1 week', 'timeFrame': 'Measured repeatedly at set intervals; at baseline, 15 minutes after baseline assessment, and once daily for 1 week', 'description': 'Patient-reported rating of pain intensity collected using the International SCI Pain Basic Data Set Version 2.0 (Widerstrom-Noga et al., 2014). This measure provides information regarding the location and severity of pain on a 0-10 scale, where higher number indicates worse pain, and categorization of pain into neuropathic and nociceptive.'}], 'secondaryOutcomes': [{'measure': 'Pain interference', 'timeFrame': 'Measured once at baseline', 'description': 'Pain interference will be collected using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference - Short Form 8a V1.0 (Amtmann et al., 2010). Pain interference is a measure of consequences of pain, rather than intensity. It incorporates aspects of pain associated with quality of life and physical functioning. A 5-point Likert scale for eight items provides a score ranging from 8-40, where a higher score indicates greater pain interference.'}, {'measure': 'Depression', 'timeFrame': 'Measured once at baseline', 'description': 'Depression will be measured using the Patient Health Questionnaire to examine its effect as a potential confounder in the interaction between physical activity and pain. This measure implements a 4-point Likert scale for nine items to calculate a score ranging from 0-27, with 0 indicating no depression and 27 indicating severe depression.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Measured once at baseline', 'description': 'The Tampa Scale for Kinesiophobia will be used in assessing kinesiophobia, which will assist in identifying if it is a confounder. This 17-item measure uses a 4-point Likert scale to calculate a score between 17-68, where higher scores indicate greater fear of movement.'}, {'measure': 'Conditioned pain modulation', 'timeFrame': 'Measured once at baseline', 'description': 'Conditioned pain modulation (CPM) is used to assess endogenous pain inhibition mechanisms. The outcome of CPM testing is either a normal effect or an abnormal effect. Abnormal CPM effect, which is an increased pain threshold after a conditioning stimulus, is an important biomarker of chronic pain (Fernandes et al., 2019).'}, {'measure': 'Virtual embodiment', 'timeFrame': 'Measured once at baseline', 'description': 'The Virtual Embodiment Questionnaire (Roth \\& Latoschik, 2020) will be used to assess embodiment with the avatar while in the immersive VR environment. This measure uses a 7-point Likert scale to calculate a score ranging from 4-28 in each of three sections that assess body ownership of the avatar, control and agency of the avatar, and sensation of body changes with the avatar. A higher score in each section indicates increased ownership, increased control, and increased body change, respectively.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'virtual reality', 'nociceptive pain', 'neuropathic pain'], 'conditions': ['Spinal Cord Injury', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '38661677', 'type': 'DERIVED', 'citation': 'Canori A, Coffman DL, Wright WG, Finley MA, Hiremath SV. Differential relationships between physical activity and pain phenotypes in individuals with spinal cord injury. J Spinal Cord Med. 2025 Jul;48(4):720-729. doi: 10.1080/10790268.2024.2344315. Epub 2024 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the relationships between: (1) physical activity (PA) and types of chronic pain (nociceptive and neuropathic), and (2) virtual reality (VR) and types of chronic pain (nociceptive and neuropathic).', 'detailedDescription': 'Chronic pain can be differentiated by its underlying mechanisms. However, this important distinction is not applied to most non-pharmacological treatment approaches. Studies that have shown modulation of chronic pain with physical activity (PA) or virtual reality (VR) have not evaluated differential effects on nociceptive and neuropathic pain. Therefore, it is unknown if neuropathic pain and nociceptive pain respond differently to PA and VR, and if treatment could be optimized through targeted interventions or a combination of interventions. Understanding the relationships between different types of pain and motor activity will provide new insight to inform future recommendations to alter PA levels for pain modulation.\n\nA prospective, cohort design will be employed for this study of individuals with SCI for a duration of one week in the community. This study will identify trends that are different between the responses of different types of pain and motor activities (i.e., PA and VR). The data obtained will also capture fluctuations in PA levels across participants and corresponding pain levels because PA levels will be collected through real-world data in the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with chronic SCI who live in the Greater Philadelphia region and have experienced chronic pain are eligible to participate in the study. Recruitment efforts will be targeted equally towards men and women of all races and ethnicities, however because SCI is more prevalent in men, we anticipate higher recruitment of men than women.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of spinal cord injury (SCI) (at least six months post-SCI)\n* Experienced chronic pain for a duration of at least 6 months\n* Functionally able to self-propel a manual wheelchair\n* Medically stable\n\nExclusion Criteria:\n\n* History of motion sickness or epilepsy\n* Condition in which PA is medically contraindicated'}, 'identificationModule': {'nctId': 'NCT05236933', 'briefTitle': 'Association Between Types of Pain and Motor Activities Physical Activity', 'organization': {'class': 'OTHER', 'fullName': 'Temple University'}, 'officialTitle': 'Association Between Types of Pain and Motor Activities Physical Activity in Individuals With Spinal Cord Injury', 'orgStudyIdInfo': {'id': '27219'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neuropathic', 'description': 'Individuals who report pain that is categorized as neuropathic will be assigned to this group.'}, {'label': 'Nociceptive', 'description': 'Individuals who report pain that is categorized as nociceptive will be assigned to this group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19122', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Temple University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}