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Pain and Impact of Chronic Pain on Function After Total Knee Replacements

NCT03032679 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 139

Last updated 2020-10-08

No results posted yet for this study

Summary

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

  • Pain, Postoperative
  • Pain, Chronic
  • Osteogenic Sarcoma
  • Knee Arthropathy

Interventions

OTHER

Non interventional study

No intervention

Sponsors & Collaborators

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • APARNA S CHATTERJEE, MD,FCARCSI · Professor

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2020-06-30
Completion
2020-08-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032679 on ClinicalTrials.gov