Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-26 @ 11:00 AM
Study NCT ID:
NCT03696134
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Musculoskeletal Health and Wellbeing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals', 'timeFrame': '5 years', 'description': 'Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, \\& Loss of Weight).'}, {'measure': 'Presence and prevalence of pain', 'timeFrame': '5 years', 'description': 'Pain distribution will be recorded in a pain manikin.'}, {'measure': 'Presence and prevalence of disability', 'timeFrame': '5 years', 'description': 'Disability will be determined using the five Fried Criteria modified for questionnaire delivery.'}], 'secondaryOutcomes': [{'measure': '1. Classification of phenotypic subgroups', 'timeFrame': '5 years', 'description': 'Demographic characteristics will be recorded; age at baseline, sex, race, socioeconomic position (deprivation index, urban/rural indicators will be derived from postcode data), smoking habits, weight, height and alcohol consumption. Fracture risk will be assessed using a modified version of the FRAX instrument (substituting secondary osteoporosis for self-reported osteoporosis and without using data for bone mineral density measurements).'}, {'measure': '2. Classification of comorbid conditions', 'timeFrame': '5 years', 'description': 'Co-morbidities will be assessed using the Charlson Comorbidity Index'}, {'measure': '3. Medication usage', 'timeFrame': '5 years', 'description': 'Participants will self-report their current medications (prescribed and over the counter).'}, {'measure': '4. Identification of potential research participants', 'timeFrame': '5 years', 'description': 'The Charlson Comorbidity Index'}, {'measure': 'Prevalence of Comorbid conditions', 'timeFrame': '5 years', 'description': 'the count of comorbidities'}, {'measure': 'Classification of Rheumatic Comorbid conditions', 'timeFrame': '5 years', 'description': 'Rheumatic Disease Comorbidity Index (RDCI).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain, Frailty, Disability']}, 'referencesModule': {'references': [{'pmid': '32199451', 'type': 'BACKGROUND', 'citation': 'Millar B, McWilliams DF, Abhishek A, Akin-Akinyosoye K, Auer DP, Chapman V, Doherty M, Ferguson E, Gladman JRF, Greenhaff P, Stocks J, Valdes AM, Walsh DA. Investigating musculoskeletal health and wellbeing; a cohort study protocol. BMC Musculoskelet Disord. 2020 Mar 21;21(1):182. doi: 10.1186/s12891-020-03195-4.'}, {'pmid': '37147635', 'type': 'DERIVED', 'citation': 'Chaplin WJ, McWilliams DF, Millar BS, Gladman JRF, Walsh DA. The bidirectional relationship between chronic joint pain and frailty: data from the Investigating Musculoskeletal Health and Wellbeing cohort. BMC Geriatr. 2023 May 5;23(1):273. doi: 10.1186/s12877-023-03949-4.'}]}, 'descriptionModule': {'briefSummary': 'Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations.\n\nMethods A prospective cohort of 10000 people aged \\> 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale).\n\nDiscussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Participants will be recruited from a broad range of sources, including the community, primary and secondary care health services. Diverse recruitment pathways will enable enrichment of the cohort with participants from a range of backgrounds and suitable for a range of potential interventions aiming to reduce frailty, pain or disability. Participants may be recruited from GP surgeries, community based clinics, Musculoskeletal Pathway (Physiotherapy and occupational health clinics in primary care), hospital patient waiting lists, hospital outpatients' lists and physiotherapy services, or as participants from previous studies undertaken by the University of Nottingham or Nottingham University Hospitals NHS Trust who have expressed an interest in future research, and people who respond to online material.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability\n\nExclusion Criteria:\n\n\\- Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia.'}, 'identificationModule': {'nctId': 'NCT03696134', 'briefTitle': 'Investigating Musculoskeletal Health and Wellbeing', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'Investigating Musculoskeletal Health and Wellbeing: A Cohort Study', 'orgStudyIdInfo': {'id': '17113'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG5 1PB', 'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Bonnie Millar', 'role': 'CONTACT'}], 'facility': 'University of Nottingham', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Bonnie Millar', 'role': 'CONTACT', 'email': 'bonnie.millar@nottingham.ac.uk', 'phone': '0115 8231754'}], 'overallOfficials': [{'name': 'David Walsh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nottingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}