Clinical trial · Observational
Pain and Impact of Chronic Pain on Function After Total Knee Replacements
Postoperative Pain Severity, Incidence Of Chronic Pain And Its Impact On Daily Function Following Total Knee Replacements (TKR) At A Tertiary Cancer Institute
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
After Institutional Review Board approval, adult patients scheduled for total knee arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a 24 month period. Interim analyses of cases who have completed the 6 month follow up as on 31st October, 2017 will be analyzed as part of the co- principle investigator's thesis. All consenting patients will be assessed for pain preoperatively, the first 3 post-operative days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute Pain Service team as per standard protocols. The Brief pain inventory (BPI) (short form with translations, obtained with permission from MD Anderson), which assesses pain severity and its impact on daily functions will be administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6 months postoperatively. The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition (impairment) after completed tumour treatment will be estimated at the end of 6 months from the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable screening tool to identify the likelihood of a neuropathic pain component in patients and validated in various languages including Hindi and Marathi will be administered preoperatively and at 1, 4 and 6 months after surgery. Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record. If the patient cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals if they cannot visit the pain clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for an assessment of MSTS score and completing the BPI and PD-Q. INCLUSION CRITERIA:- * Adult patients above 18 years of age, undergoing TKR * Literate: able to read and write in at least one of the following languages English, Hindi and Marathi * Willing to fill forms and post them and/or answer questions on phone EXCLUSION CRITERIA:- * Refusal of consent * Cognitively impaired * Revision TKRs (including cases with wound wash and nail spacer cementing)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Knee Arthropathy | — | UNRESOLVED | — |
| Osteogenic Sarcoma | Osteosarcoma | ALIAS | 0.90 |
| Pain, Chronic | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non interventional study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single group of patients
- description
- Non interventional study. Observational with questionnaires
- interventionNames
- Other: Non interventional study
Primary outcomes (1)
- measure
- pain severity in the immediate post-operative period following oncologic TKRs
- timeFrame
- First 3 postoperative days
- description
- Pain scores as per the numerical rating scale
Secondary outcomes (3)
- measure
- the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP)
- timeFrame
- 4 and 6 months after surgery
- description
- As assessed from the brief pain inventory
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients above 18 years of age, undergoing TKR * Literate: able to read and write in at least one of the following languages English, Hindi and Marathi * Willing to fill forms and post them and/or answer questions on phone Exclusion Criteria: * Refusal of consent * Cognitively impaired * Revision knee arthroplasty (including cases with wound wash and nail spacer cementing)
References
Publications (8)
- BACKGROUNDNguyen MP, Buckwalter JA, Miller BJ. Patterns of improvement following oncologic reconstructrion compared to total knee arthroplasty and revision knee arthroplasty. Iowa Orthop J. 2011;31:160-5. PMID 22096436
- BACKGROUNDBeswick 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 25967998
- BACKGROUNDHaroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010. PMID 23273105
- BACKGROUNDAyers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005 Nov;440:157-61. doi: 10.1097/01.blo.0000185447.43622.93. PMID 16239800
- BACKGROUNDKehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. PMID 16698416
- BACKGROUNDTunn PU, Pomraenke D, Goerling U, Hohenberger P. Functional outcome after endoprosthetic limb-salvage therapy of primary bone tumours--a comparative analysis using the MSTS score, the TESS and the RNL index. Int Orthop. 2008 Oct;32(5):619-25. doi: 10.1007/s00264-007-0388-8. Epub 2007 Aug 15. PMID 17701173
- BACKGROUNDMathieson S, Lin C. painDETECT questionnaire. J Physiother. 2013 Sep;59(3):211. doi: 10.1016/S1836-9553(13)70189-9. No abstract available. PMID 23896340
- Jain P, Padole D, Bakshi S. Prevalence of acute neuropathic pain after cancer surgery: A prospective study. Indian J Anaesth. 2014 Jan;58(1):36-42. doi: 10.4103/0019-5049.126788.