Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-04-14 @ 7:05 AM
Study NCT ID:
NCT02070367
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2014-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Somatosensory Assessment and Rehabilitation of Allodynia (SARA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}, {'id': 'D006930', 'term': 'Hyperalgesia'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-08', 'studyFirstSubmitDate': '2014-02-03', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '10 test', 'timeFrame': 'Baseline to 3 months', 'description': 'quick form of quantitative sensory testing for light touch sensation and hypersensitivity'}, {'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'Baseline to 6 months', 'description': 'Measures pain-related beliefs'}, {'measure': 'Allodynography', 'timeFrame': 'Baseline to 3 months', 'description': 'a graphical technique to anatomically map allodynia associated with a specific nerve branch and assess the area and associated pressure threshold'}, {'measure': 'Infra-red skin temperature measurement asymmetry', 'timeFrame': 'Baseline and 3 months', 'description': 'Infra-red measures of skin temperature are taken over 3 specific areas (corresponding to the most distal autonomous innervation from the 3 major peripheral nerves of the upper limb) and symmetry is compared between the right and left arms. This measurement procedure is then repeated after a 30 second immersion of the right foot in ice water (5 degrees C).'}, {'measure': 'Goniometric measurement of active range of motion (ROM) of the upper extremities', 'timeFrame': 'Baseline to 3 months', 'description': 'Measures of affected and unaffected limbs (shoulder flexion and abduction, elbow flexion/extension, wrist flexion/extension, forearm pronation/supination, active functional ROM of the fingers, thumb opposition).'}, {'measure': 'Dynamometry for grip and pinch strength', 'timeFrame': 'Baseline to 3 months', 'description': 'bilateral measures of hand grip and pinch strength'}], 'primaryOutcomes': [{'measure': 'McGill Pain Questionnaire', 'timeFrame': 'baseline to 6 month follow-up', 'description': 'total number and intensity of sensory and affective pain descriptors selected by participant'}], 'secondaryOutcomes': [{'measure': 'Pain subscale of the Patient-Rated Wrist and Hand Evaluation', 'timeFrame': 'Baseline to six months', 'description': '5 questions rating self-reported pain at rest, with movement, pain with lifting, worst pain and pain frequency.'}, {'measure': 'Hamilton Inventory for Complex Regional Pain Syndrome', 'timeFrame': 'Baseline to 6 months', 'description': 'Includes a both a patient-reported scale addressing symptoms, daily function and psychosocial concerns; and a clinician-based assessment of clinical signs'}, {'measure': 'Radboud Evaluation of Sensitivity- English version', 'timeFrame': 'Baseline to 6 months', 'description': 'self-reported evaluation of sensitivity in an area of injury/trauma'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allodynia', 'complex regional pain syndrome', 'peripheral nerve injuries', 'clinical measurement properties'], 'conditions': ['Complex Regional Pain Syndrome', 'Peripheral Nerve Injuries', 'Hand Fractures']}, 'referencesModule': {'references': [{'pmid': '22975739', 'type': 'BACKGROUND', 'citation': 'Packham TL, Fok D, Frederiksen K, Thabane L, Buckley N. Reliability of infrared thermometric measurements of skin temperature in the hand. J Hand Ther. 2012 Oct-Dec;25(4):358-61; quiz 362. doi: 10.1016/j.jht.2012.06.003. Epub 2012 Sep 10.'}, {'pmid': '22265445', 'type': 'BACKGROUND', 'citation': 'Packham T, MacDermid JC, Henry J, Bain JR. The Hamilton Inventory for Complex Regional Pain Syndrome: a cognitive debriefing study of the clinician-based component. J Hand Ther. 2012 Jan-Mar;25(1):97-111; quiz 112. doi: 10.1016/j.jht.2011.09.007.'}, {'pmid': '35005383', 'type': 'DERIVED', 'citation': 'Packham T, MacDermid J, Bain J, Buckley N. Identification of complex regional pain syndrome in the upper limb: Skin temperature asymmetry after cold pressor test. Can J Pain. 2018 Aug 21;2(1):248-257. doi: 10.1080/24740527.2018.1504283. eCollection 2018.'}, {'pmid': '31858880', 'type': 'DERIVED', 'citation': 'Packham TL, Spicher CJ, MacDermid JC, Quintal I, Buckley N. Evaluating a sensitive issue: reliability of a clinical evaluation for allodynia severity. Somatosens Mot Res. 2020 Mar;37(1):22-27. doi: 10.1080/08990220.2019.1704242. Epub 2019 Dec 20.'}, {'pmid': '30908579', 'type': 'DERIVED', 'citation': 'Packham TL, Spicher CJ, MacDermid JC, Buckley ND. Allodynography: Reliability of a New Procedure for Objective Clinical Examination of Static Mechanical Allodynia. Pain Med. 2020 Jan 1;21(1):101-108. doi: 10.1093/pm/pnz045.'}]}, 'descriptionModule': {'briefSummary': "This pilot study will test a new therapy, somatosensory rehabilitation, for the painful sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's evaluation of their own symptoms and the impact of these symptoms on their daily activities will also be tested to make sure they are consistent and accurate.\n\nPrevious research has suggested one of the assessments may also be used to assist in the identification of CRPS: this simple test will be evaluated to see if it can accurately identify persons with this disorder (for which there is currently no diagnostic test). Together, this will improve treatment of CRPS through early, accurate diagnosis and the ability to measure important changes in this painful condition, and set up future studies for this new rehabilitation treatment method.", 'detailedDescription': 'We will test four groups: persons with CRPS of one upper extremity, persons with recent hand fractures (\\<12 weeks) or peripheral nerve injuries with residual sensory deficits at the time of the study, and healthy normal volunteers with a battery of assessments for CRPS, including a technique to precisely localize and quantify static mechanical allodynia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of a) Complex Regional Pain Syndrome or b) Peripheral Nerve Injury or c) recent hand trauma without peripheral nerve injury in a single upper extremity confirmed by physician or medical record.\n* Participant and most responsible physician give consent to exclusive focus on somatosensory rehabilitation for the duration of the trial (6 months). The participant may continue any oral medications but any planned use of topical medication, injections or IV medication in the affected limb is contra-indicated. Use of these modalities in an emergency situation would of course take priority.\n\nExclusion Criteria:\n\n* History of cardiac or vascular disease or known sensitivity to sympathetic stress or cold intolerance or medically unstable\n* Confounding diagnoses: whiplash, nerve root compression, metabolic diseases such as diabetes or thyroid problems, and/or peripheral neuropathy\n* Open wounds on testing sites\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02070367', 'acronym': 'SARA', 'briefTitle': 'Somatosensory Assessment and Rehabilitation of Allodynia (SARA)', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Somatosensory Assessment and Rehabilitation of Allodynia: the SARA Pilot Study', 'orgStudyIdInfo': {'id': '13-798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Somatosensory rehabilitation', 'description': 'Weekly sessions with a certified (RSDC) somatosensory therapist using distal vibro-tactile counter-stimulation to anatomically related territories of the area of allodynia. Participants will also be provided with a structured home exercise program.', 'interventionNames': ['Other: Somatosensory rehabilitation', 'Other: Usual treatment: physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual treatment', 'description': 'Treatment as usual for condition Physiotherapy sessions', 'interventionNames': ['Other: Usual treatment: physiotherapy']}], 'interventions': [{'name': 'Somatosensory rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['Somatosensory rehabilitation']}, {'name': 'Usual treatment: physiotherapy', 'type': 'OTHER', 'armGroupLabels': ['Somatosensory rehabilitation', 'Usual treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L9G 3L1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton Health Science, General Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Joy C MacDermid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Rehabilitation Sciences, McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}