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

NCT03032679 | Completed DMC

• 1 other identifier: 1780
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

pain, acute, chronic, knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• pain severity in the immediate post-operative period following oncologic TKRs

  Pain scores as per the numerical rating scale

  First 3 postoperative days

Secondary Outcomes (3)

• the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP)

  4 and 6 months after surgery

• • To identify the type of pain (neuropathic component) persisting at 4 and 6 months after TKR

  4 and 6 months from surgery

• Impact of the pain on daily function

  4 and 6 months after surgery

Study Arms (1)

Single group of patients

Non interventional study. Observational with questionnaires

Other: Non interventional study

Interventions

Non interventional study OTHER

No intervention

Single group of patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for total knee arthroplasty for osteogenic sarcoma

You may qualify if:

• 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

You may not qualify if:

• Refusal of consent
• Cognitively impaired
• Revision knee arthroplasty (including cases with wound wash and nail spacer cementing)

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

Location

Related Publications (8)

• Nguyen 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 BACKGROUND

• 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: 25967998 BACKGROUND

• Haroutiunian 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 BACKGROUND

• Ayers 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 BACKGROUND

• Kehlet 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 BACKGROUND

• Tunn 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 BACKGROUND

• Mathieson 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 BACKGROUND

• 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.

  PMID: 24700897 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Osteosarcoma; Pain; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• APARNA S CHATTERJEE, MD,FCARCSI

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: January 26, 2017
• Study Start: February 2, 2017
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)