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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032679
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Aparna Chatterjee, Tata Memorial Centre

Brief 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)

Condition or disease Intervention/treatment
Pain, Postoperative Pain, Chronic Osteogenic Sarcoma Knee Arthropathy Other: Non interventional study

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single group of patients
Non interventional study. Observational with questionnaires
Other: Non interventional study
No intervention




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. • 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients scheduled for total knee arthroplasty for osteogenic sarcoma
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: APARNA S CHATTERJEE, MD, FCARCSI 022 24177000 ext 7051 aparnasanjay@hotmail.com
Contact: BHAVYA VAKIL, MBBS 919870863234 bhavyakru24@gmail.com

Locations
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India
Tata Memorial Centre Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Aparna S Chatterjee, MD, FCARCSI    022 24177000 ext 7051    aparnasanjay@hotmail.com   
Contact: Bhavya Vakil, MBBS    919870863234    bhavyakru24@gmail.com   
Sponsors and Collaborators
Tata Memorial Centre
Investigators
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Principal Investigator: APARNA S CHATTERJEE, MD,FCARCSI Professor
Publications:

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Responsible Party: Dr Aparna Chatterjee, Professor, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT03032679    
Other Study ID Numbers: 1780
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Aparna Chatterjee, Tata Memorial Centre:
pain, acute, chronic, knee arthroplasty
Additional relevant MeSH terms:
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Osteosarcoma
Joint Diseases
Chronic Pain
Pain, Postoperative
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue