Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-11 @ 11:30 AM
Study NCT ID:
NCT03886259
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2019-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 456383, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-18T04:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blinded towards group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2019-03-20', 'studyFirstSubmitQcDate': '2019-03-21', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': 'Baseline', 'description': 'The questionnaire consists of 14 items, which measures the patient level of anxiety and depression. The score in each item ranges from 0-3, giving scoring ranges from 0-21.'}], 'primaryOutcomes': [{'measure': 'Change in Knee Injury and Osteoarthritis Outcome Score4 (KOOS4) from baseline to 12months follow-up', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be performed.'}], 'secondaryOutcomes': [{'measure': 'Change in all five subscales of the KOOS', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'All five domains, covering pain, symptoms, difficulties in functions of daily living, sport and recreation and quality of life of the questionnaire will be used as secondary outcome with scores ranging from 0 (worst) to 100 (best).'}, {'measure': 'Rating of Global Perceived Effect', 'timeFrame': '3, 6 and 12 months', 'description': 'Global Perceived Effect will be assessed using the question: "How are your knee problems now compared with before you entered this study"? The question will be answered on a seven-point Likert scale ranging from \'Improved, an important improvement\' to \'Worse, an important worsening\'.'}, {'measure': 'Change in maximal pain intensity during rest (day and night), stair climbing, and walking on a Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Pain intensities on a NRS, where "0" represents "no pain" and "10" represents "maximal pain" in various situations.'}, {'measure': 'Change in use of Pain Medication', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Dosage of pain medication used within last week'}, {'measure': 'Number of adverse events related to interventions', 'timeFrame': '3 months', 'description': 'Serious and non-serious events that may occur during the intervention period will be identified in different ways: by self-reporting by the participants and by observation from the physiotherapists. Adverse events will be categorized as occurring in the index knee or other sites than the index knee.'}, {'measure': 'Change in 40-meter fast-paced walk test', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The amount of time in seconds it takes to complete the 40m'}, {'measure': 'Change in stair climb test', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The amount of time in seconds it takes to complete ascending and descending of 9 stairs'}, {'measure': 'Change in 30-second chair stand test', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Number of repetitions in 30-seconds'}, {'measure': 'Change in PainDETECT scores', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The questionnaire is comprised of 3 major components: graduation of pain, pain course pattern and radiating pain. The maximum possible score is 38, and the minimum possible score is -1.'}, {'measure': 'Change in score from the Fear-avoidance Beliefs Questionnaire - Physical Activity', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The scores range from "0" with "completely disagree" to "6" with "completely agree" and sums up to a total score between 0-24.'}, {'measure': 'Change in score from the Pain Catastrophizing Scale', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Scores is rated on a 5-point scale with the 0 being "not at all" and 4 being "all the time" and the score can range from 0 to 52 points.'}, {'measure': 'Change in pinprick hyperalgesia at index knee and extrasegmental', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The subject is to rate the pain intensity from the pinprick on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".'}, {'measure': 'Change in temporal summation at index knee and extrasegmental', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The subject is to rate the pain intensity of the last test stimulus on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".'}, {'measure': 'Change in dynamic mechanical allodynia at the index knee and extrasegmental', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'The subject is to rate the pain intensity of a cotton swab on a NRS, where "0" represents "no pain" and "10" represents "maximal pain".'}, {'measure': 'Change in deep somatic hyperalgesia at the index knee and extrasegmental', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'A "bedside algometer" will be applied on the skin over the vastus medialis muscle on the index side. The subject is to indicate immediately when the pressure becomes painful.'}, {'measure': 'Change in pressure pain thresholds at the index knee and extrasegmental', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Pressure pain thresholds measured using a handheld algometer (Algometer Type II, Somedic AB, Hoerby, Sweden)) at the index knee and extrasegmental.'}, {'measure': 'Change in descending pain control', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Conditioned pain modulation effect will be measured comparing the test stimuli without conditioning stimuli to the test stimuli with conditioning stimuli'}, {'measure': 'Change in number of sites with usual pain shaded on a body chart', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Shaded markings on a body chart to indicate where usual pain is located'}, {'measure': 'Change in leg extension power', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Leg extension power in a single-leg simultaneous hip and knee extension will be measured bilaterally. Highest measurement in watt is the outcome.'}, {'measure': 'Change in isometric muscle strength of knee extensors and flexors', 'timeFrame': 'Baseline and at 3, 6 and 12 months', 'description': 'Maximum isometric muscle strength (measured in Newtons) measured bilaterally in knee flexion and knee extension in a test using a handheld dynamometer (Lafayette manual muscle tester from Lafayette Instruments, USA).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Pain', 'Total Knee Arthroplasty', 'Pain Neuroscience Education', 'Neuromuscular exercise (NEMEX-TJR)'], 'conditions': ['Arthroplasty, Replacement, Knee', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '11156538', 'type': 'BACKGROUND', 'citation': 'Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis. 2001 Feb;60(2):91-7. doi: 10.1136/ard.60.2.91.'}, {'pmid': '15766999', 'type': 'BACKGROUND', 'citation': 'Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.'}, {'type': 'BACKGROUND', 'citation': 'Davidson D, de Steiger R, Graves S, Tomkins A et al. Australian orthopaedic association national joint replacement registry. annual report. Adelaide:AOA;2010. . 2010'}, {'pmid': '22398175', 'type': 'BACKGROUND', 'citation': 'Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.'}, {'pmid': '16326719', 'type': 'BACKGROUND', 'citation': 'Bhave A, Mont M, Tennis S, Nickey M, Starr R, Etienne G. Functional problems and treatment solutions after total hip and knee joint arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:9-21. doi: 10.2106/JBJS.E.00628. No abstract available.'}, {'pmid': '17596949', 'type': 'BACKGROUND', 'citation': 'Wylde V, Dieppe P, Hewlett S, Learmonth ID. Total knee replacement: is it really an effective procedure for all? Knee. 2007 Dec;14(6):417-23. doi: 10.1016/j.knee.2007.06.001. Epub 2007 Jun 26.'}, {'pmid': '22357571', 'type': 'BACKGROUND', 'citation': 'Beswick AD, Wylde V, Gooberman-Hill R, Blom A, Dieppe P. What proportion of patients report long-term pain after total hip or knee replacement for osteoarthritis? A systematic review of prospective studies in unselected patients. BMJ Open. 2012 Feb 22;2(1):e000435. doi: 10.1136/bmjopen-2011-000435. Print 2012.'}, {'pmid': '28681962', 'type': 'BACKGROUND', 'citation': 'Wylde V, Dennis J, Beswick AD, Bruce J, Eccleston C, Howells N, Peters TJ, Gooberman-Hill R. Systematic review of management of chronic pain after surgery. Br J Surg. 2017 Sep;104(10):1293-1306. doi: 10.1002/bjs.10601. Epub 2017 Jul 6.'}, {'pmid': '25967998', 'type': 'BACKGROUND', 'citation': 'Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015 May 12;5(5):e007387. doi: 10.1136/bmjopen-2014-007387.'}, {'pmid': '32197629', 'type': 'BACKGROUND', 'citation': 'Larsen JB, Skou ST, Arendt-Nielsen L, Simonsen O, Madeleine P. Neuromuscular exercise and pain neuroscience education compared with pain neuroscience education alone in patients with chronic pain after primary total knee arthroplasty: study protocol for the NEPNEP randomized controlled trial. Trials. 2020 Feb 24;21(1):218. doi: 10.1186/s13063-020-4126-5.'}, {'pmid': '38787559', 'type': 'DERIVED', 'citation': 'Larsen JB, Skou ST, Laursen M, Bruun NH, Arendt-Nielsen L, Madeleine P. Exercise and Pain Neuroscience Education for Patients With Chronic Pain After Total Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2412179. doi: 10.1001/jamanetworkopen.2024.12179.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate whether a 12-week neuromuscular rehabilitation program (NEMEX-TJR) combined with pain neuroscience education (PNE) provides greater pain relief, improvement in physical function and quality of life than PNE alone in a population of patients with chronic pain after primary total knee arthroplasty.\n\nHypothesis: Rehabilitation involving neuromuscular training and PNE will provide greater pain relief, improved function and improved quality of life compared to PNE alone at the primary endpoint, which is follow-up 12months after the start of the treatment.', 'detailedDescription': 'Osteoarthritis is considered the most frequent cause of disability and pain in the elderly population, and the knee joint is one of the joints most commonly affected.\n\nEnd-stage osteoarthritis is often treated with knee replacement, and total knee arthroplasty is considered an effective treatment for pain relief and improved function. However, several studies have reported less favorable outcomes after total knee arthroplasty, and systematic reviews found chronic pain after total knee arthroplasty at 12 months post-operative in 13-17% of the patients and chronic pain rates at 2-7 years post-operative varying between 8-27%. No randomized controlled trials evaluating exercise and pain education treatments to patients with chronic pain after total knee arthroplasty exists, and this highlights the need for evidence-based knowledge of which treatment should be considered for this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) between 19-40\n* Subjects with primary total knee arthroplasty due to osteoarthritis ≥ 12 months post-operatively\n* For the index knee, duration of knee pain \\> 6 months\n* For the index knee, the average daily pain score ≥ 4 (moderate-to-severe pain) over the last week prior to visit on a numeric rating scale\n\nExclusion Criteria:\n\n* Specific reasons for chronic pain, such as loosening of implant, which requires revision surgery\n* Secondary causes of arthritis to the knee, e.g. rheumatoid arthritis\n* Surgery (including arthroscopy) of the index knee within 3 months prior to visit\n* Injury to the index knee within 12 months prior to visit\n* Recent history of acute pain affecting the lower limb and/or trunk\n* Participation in other pain trials two weeks prior to this study\n* Pregnancy\n* Drug and alcohol abuse\n* Previous neurologic illnesses or primary pain area other than knee, e.g. lower back, upper extremity pain or rheumatoid arthritis\n* Lack of ability to adhere to protocol'}, 'identificationModule': {'nctId': 'NCT03886259', 'briefTitle': 'Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': 'Effect of Neuromuscular Exercise in Combination With Pain Neuroscience Education Compared to Pain Neuroscience Education Alone in Patients With Chronic Pain After Primary Total Knee Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'N-20180046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and pain neuroscience education', 'description': 'Subjects with chronic pain after total knee replacement will receive 24 sessions of neuromuscular exercise therapy, supervised by a physiotherapist, and two sessions of pain neuroscience education, conducted by a physiotherapist', 'interventionNames': ['Other: Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain neuroscience education', 'description': 'Subjects with chronic pain after total knee replacement will receive two sessions of pain neuroscience education, conducted by a physiotherapist', 'interventionNames': ['Other: Pain neuroscience education']}], 'interventions': [{'name': 'Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education', 'type': 'OTHER', 'description': '60min. of neuromuscular exercises (NEMEX-TJR) training two times a week for 3 months (12 weeks, 24 sessions). Physiotherapists will instruct and supervise the participants during the neuromuscular exercises. The aim of the neuromuscular exercise program is to restore normal movement, improve sensorimotor control, re-establishing normal motor program strategies and muscle activation.\n\n60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function.', 'armGroupLabels': ['Exercise and pain neuroscience education']}, {'name': 'Pain neuroscience education', 'type': 'OTHER', 'description': '60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function.', 'armGroupLabels': ['Pain neuroscience education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Occupational and Physiotherapy, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '9640', 'city': 'Farsø', 'country': 'Denmark', 'facility': 'Department of Occupational- and Physiotherapy, Aalborg University Hospital', 'geoPoint': {'lat': 56.77276, 'lon': 9.33925}}, {'zip': '7700', 'city': 'Thisted', 'country': 'Denmark', 'facility': 'Department of Occupational- and Physiotherapy, Aalborg University Hospital', 'geoPoint': {'lat': 56.95523, 'lon': 8.69491}}], 'overallOfficials': [{'name': 'Pascal Madeleine, Dr.Scient', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University'}, {'name': 'Søren T Skou, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern Denmark and Næstved-Slagelse-Ringsted Hospitals'}, {'name': 'Ole Simonsen, Dr.Med', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University Hospital'}, {'name': 'Lars Arendt-Nielsen, Dr.Med', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University'}, {'name': 'Jesper B Larsen, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aalborg University'}, {'name': 'Mogens B Laursen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Beginning 3 months following publication. No end date.', 'ipdSharing': 'YES', 'description': 'Individual subject data that underlie the results reported in the publication will be shared after deidentification (text, tables, figures, appendices)', 'accessCriteria': 'Researchers that provide a methodologically sound plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northern Orthopaedic Division, Denmark', 'class': 'OTHER'}, {'name': 'The Danish Rheumatism Association', 'class': 'OTHER'}, {'name': 'Svend Andersen Foundation', 'class': 'UNKNOWN'}, {'name': 'Lions Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD-student', 'investigatorFullName': 'Jesper Bie Larsen', 'investigatorAffiliation': 'Aalborg University'}}}}