Pain and Impact of Chronic Pain on Function After Total Knee Replacements
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|ClinicalTrials.gov Identifier: NCT03032679|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 12, 2020
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.
- 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
- Refusal of consent
- Cognitively impaired
- Revision TKRs (including cases with wound wash and nail spacer cementing)
|Condition or disease||Intervention/treatment|
|Pain, Postoperative Pain, Chronic Osteogenic Sarcoma Knee Arthropathy||Other: Non interventional study|
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||Postoperative Pain Severity, Incidence Of Chronic Pain And Its Impact On Daily Function Following Total Knee Replacements (TKR) At A Tertiary Cancer Institute|
|Actual Study Start Date :||February 2, 2017|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Single group of patients
Non interventional study. Observational with questionnaires
Other: Non interventional study
- pain severity in the immediate post-operative period following oncologic TKRs [ Time Frame: First 3 postoperative days ]Pain scores as per the numerical rating scale
- the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP) [ Time Frame: 4 and 6 months after surgery ]As assessed from the brief pain inventory
- • To identify the type of pain (neuropathic component) persisting at 4 and 6 months after TKR [ Time Frame: 4 and 6 months from surgery ]Neuropathic component to be identified by using the pain Detect
- Impact of the pain on daily function [ Time Frame: 4 and 6 months after surgery ]Brief pain inventory and the MSTS score to assess the interference of pain with daily function and how it compares with MSTS at 6 month
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032679
|Contact: APARNA S CHATTERJEE, MD, FCARCSI||022 24177000 ext email@example.com|
|Contact: BHAVYA VAKIL, MBBSfirstname.lastname@example.org|
|Principal Investigator:||APARNA S CHATTERJEE, MD,FCARCSI||Professor|