Hip Osteoarthritis
Conditions
Interventions
Trade Name: Paracetamol
Product Name: Paracetamol
Product Code: Paracetamol
Pharmaceutical Form: Capsule*
INN or Proposed INN: paracetam
Sponsors
MRC Health Services Research Collaboration
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged older than 65 years with symptomatic OA of the hip (2) Chronic pain, defined as pain being present for at least three months, scoring 4 or more on an eleven point pain scale (3) Able to walk six meters, (4) Living in Bristol and been referred to the Avon Orthopaedic Centre in North Bristol Health Care Trust for total hip arthroplasty, (5) Patients whose primary care clinicians have agreed to support the study (6) Patients who are currently being prescribed NSAID for their pain (7) Patients who give written informed consent to take part in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (1) Those patients with severe co-morbidity whom it is believed would be unable to complete the trial, (2) Previous intolerance/severe adverse events to Paracetamol or OxyContin, (3) Current or previous history of alcohol abuse (assessed using the CAGE questionnaire) (4) Current or previous history of problem drug use (5) Current or previous history of a psychotic illness (6) Patient who primary care clinicians considers may be at risk of additional central nervous system depressant effects with the study medication (7) Lack of ability to take oral medication (8) Patients with dementia (9) Patients without primary care clinician approval (10) Patients unable to give informed consent (11) Patients without a reduction in pain by at least 2 points on an eleven-point pain scale within the two-week titration period. (12) Patients who the researchers consider to be unsuitable to take part in the study for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine patient acceptability of modified release OxyContin for pain management in patients with moderate to server osteoarthritis of the hip. ; Secondary Objective: To examine how effective modified release OxyContin is for: - Managing pain (Constant, spontaneous and activity related) - Increasing physical functioning - Reducing the pain distress - Improving participant determined outcomes - Improving psychological distress - Improving quality of life ;Primary end point(s): At the end of the 12-week trial the patient will decide which treatment they prefer. If they choose to continue on OxyContin they will be monitored every three weeks until their joint replacement. If the patient choose Paracetamol or to go back to the original medication the trial will end at the post trial interview. | — |
Countries
United Kingdom
Outcome results
None listed