Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-31 @ 1:06 PM
Study NCT ID:
NCT04522934
Status:
COMPLETED
Last Update Posted:
2020-08-21
First Post:
2020-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessor responsible for the outcome measures was blinded to the subjetc´s treatment assignment. The assessor was not present in the room while the treatment was delivered. He returned once the treatment was completed to perform the measurements.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to groups by using an online random generator. This procedure was conducted by an external assessor. The allocation concealment strategy included the use of sealed-opaque and consecutively numbered envelopes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-18', 'studyFirstSubmitDate': '2020-08-16', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change Pain intensity: visual analogue scale', 'timeFrame': 'From baseline to the end of intervention (8 weeks)', 'description': 'The visual analogue scales is a self-reporting measure of pain intensity. This involves asking patients to rate their pain intensity by selecting a point in a straight horizontal line of fixed length, usually 10 cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best). The Minimal Clinically Important Difference (MCID) in subjects with shoulder pain is 2.2 cm.'}, {'measure': 'Pain catastrophizing', 'timeFrame': 'From baseline to the end of intervention (8 weeks)', 'description': 'Pain catastrophic was assessed using the Patient Catastrophizing Scale (PCS), a 52-point self-administered instrument with MCID of 4.5 points.'}, {'measure': 'Kinesiophobia', 'timeFrame': 'From baseline to the end of intervention (8 weeks)', 'description': 'Kinesiophobia was assessed using the Tampa Scale of Kinesiophobia (TSK-11), a 44-point self-administered instrument with MCID established at 6.0 points'}, {'measure': 'Disability', 'timeFrame': 'From baseline to the end end of intervention (8 weeks)', 'description': 'The degree of disability was assessed with the QuickDASH questionnaire, a self-administered instrument which expresses the degree of disability as a percentage on a scale of 0-100%, with MCID of 8% in subjects with shoulder pain.'}, {'measure': 'Health-related quality of life: 5-dimension EuroQol questionnaire', 'timeFrame': 'From baseline to the end of intervention (8 weeks)', 'description': 'The health-related quality of life was assessed with the 5-dimension EuroQol questionnaire, with MCID established on a scale of 0.03-0.52 in the population with musculoskeletal pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Injuries']}, 'descriptionModule': {'briefSummary': "The aim of this study was to evaluate the effects of a 8-week pain neuroscience education programme compared to a biomedical education programme on the rehabilitation of patients who undergo arthroscopic rotator cuff repair. Outcome measures included pain intensity, patients' attitudes and beliefs about pain, disability and quality of life.", 'detailedDescription': 'This was a single-blinded, randomized parallel study. Twenty- nine patients who undergo arthroscopic rotator cuff repair took part in a multimodal physiotherapy programme and were allocated to two groups. Patients in the experimental group - PNE (n= 16) received multimodal physiotherapy along with pain neuroscience education, and the control group- PME (n=13) received multimodal physiotherapy along with biomedical education. The multimodal treatment included 1-hour sessions 3 times per week for 8 weeks (24 sessions). In addition, the education component (PNE, PME) consisted of 4 education sessions of 30 minutes duration, on a one-to-one basis, once per week at the start of the programme.\n\nPhysiotherapists involved in the delivery of the interventions were previously trained on both, the theoretical and practical aspects related to the protocols of multimodal physiotherapy and specially on the education component.\n\nOutcome measures included pain intensity (pain intensity numerical rating score), catastrophizing, kinesiophobia, disability and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People aged 30 to 59 years with shoulder pain for more than three months, with torn rotator cuff repaired by arthroscopy.\n\nExclusion Criteria:\n\n* Subjects unable to understand, read or speak Spanish, or participated in a programme for psychological management of chronic pain, or presented with generalised pain.'}, 'identificationModule': {'nctId': 'NCT04522934', 'briefTitle': 'A Pilot Randomized Trial of Pain Neuroscience Education in the Rehabilitation After Arthroscopic Rotator Cuff Repair', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Católica del Maule'}, 'officialTitle': "A Pilot Randomized, Controlled Trial of the Effectiveness of Pain Neuroscience Education on Pain Intensity, Patients' Attitudes and Beliefs About Pain, Disability and Quality of Life After Arthroscopic Rotator Cuff Repair", 'orgStudyIdInfo': {'id': 'Neuroscience Rotator Cuff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pain Neuroscience Education', 'description': 'Patients received 24 sessions, in a 8-week period, of multimodal physiotherapy along with four sessions of pain neuroscience education.', 'interventionNames': ['Behavioral: Pain Neuroscience Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Biomedical Education', 'description': 'Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy along with four sessions of biomedical education.', 'interventionNames': ['Behavioral: Biomedical Education']}], 'interventions': [{'name': 'Pain Neuroscience Education', 'type': 'BEHAVIORAL', 'description': 'Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.', 'armGroupLabels': ['Pain Neuroscience Education']}, {'name': 'Biomedical Education', 'type': 'BEHAVIORAL', 'description': 'Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.', 'armGroupLabels': ['Biomedical Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4780000', 'city': 'Temuco', 'state': 'Región de la Araucanía', 'country': 'Chile', 'facility': 'Hospital de Temuco', 'geoPoint': {'lat': -38.73628, 'lon': -72.59738}}], 'overallOfficials': [{'name': 'Felipe Ponce, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Santo Tomas, Chile'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Católica del Maule', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Jorge Fuentes', 'investigatorAffiliation': 'Universidad Católica del Maule'}}}}