Protocol to investigate the effect of cyclo-oxygenase (COX)-2 inhibition on reducing central sensitisation of pain in osteoarthritis

ISRCTN	ISRCTN36231538
DOI	https://doi.org/10.1186/ISRCTN36231538
EudraCT/CTIS number	2006-000395-32
Secondary identifying numbers	N/A

Submission date: 28/07/2008
Registration date: 30/09/2008
Last edited: 17/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ernest Choy
Scientific

Weston Education Centre
10 Cutcombe Road
London
SE5 9RJ
United Kingdom

Phone	+44 (0)207 848 5206
Email	kch-tr.kms-ctu@nhs.net

Study information

Study design	Non-randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Protocol to investigate the effect of cyclo-oxygenase (COX)-2 inhibition on reducing central sensitisation of pain in osteoarthritis
Study objectives	This study aims to assess whether cyclo-oxygenase (COX)-2 selective inhibition by etoricoxib reduces central sensitisation of pain in patients with chronic osteoarthritis (OA) using functional magnetic resonance imaging (fMRI) scan.
Ethics approval(s)	St Thomas' Hospital Research Ethics Committee. Date of approval: 23/03/2006
Health condition(s) or problem(s) studied	Osteoarthritis
Intervention	16 patients will be recruited from the Rheumatology Outpatient Clinic of King's College Hospital. 16 healthy controls will be recruited from the staff and student population at King's College London (32 participants in total). Interventions: Etoricoxib (oral) 60 mg daily for 2 weeks vs no treatment
Intervention type	Other
Primary outcome measure	1. Pressure pain thresholds (PPTs) will be determined using a pressure algometer. Patients will be asked to indicate the site of ongoing pain on a mannequin. This site and the homologous contralateral site will be marked with a pen and noted in the patient record. The pressure pain level will be assessed twice at each site (rate of stimulus increase 50 kPa; probe area 1 cm2) and the average of two perception levels will be calculated as the individual PPT for that site. 2. Functional MRI (fMRI) will be used to assess brain responses to a standardised pain provocation produced by pressure delivered to a non fibromyalgia syndrome (FMS) pressure point of the knee. The fMRI evaluation will involve multiple 8 min scans using an event-related design. Pressure stimuli of 2.5 seconds duration will be delivered to the right knee at random intervals varying between 10 and 20 seconds. This will then be repeated for the left knee. The control group will have only one scan. Assessments will be carried out at baseline and after 2 weeks of treatment with etoricoxib for OA patients. Healthy controls will only complete baseline assessments.
Secondary outcome measures	1. Mechanoreceptive function 2. Sensitivity to stimulus invoked pain Assessments will be carried out at baseline and after 2 weeks of treatment with etoricoxib for OA patients. Healthy controls will only complete baseline assessments.
Overall study start date	01/09/2008
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	32
Key inclusion criteria	For all participants: 1. Both males and females, age >18 years old 2. Those who are right handed 3. Signed informed consent For participants with OA: 1. Patients with ACR criteria defined OA of the knee 2. Radiological OA 3. Patients who have been suffering from pain for more than 1 year
Key exclusion criteria	1. History of hypersensitivity to the active substance or to any of the excipients 2. Active peptic ulceration or active gastro-intestinal (GI) bleeding 3. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors 4. Pregnancy and lactation 5. Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score >=10) 6. Estimated renal creatinine clearance <30 ml/min 7. Inflammatory bowel disease 8. Congestive heart failure (New York Heart Association [NYHA] II-IV) 9. Patients with hypertension whose blood pressure has not been adequately controlled
Date of first enrolment	01/09/2008
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Weston Education Centre

London
SE5 9RJ
United Kingdom

Sponsor information

Kings College London (UK)
University/education

Strand
London
WC2R 2LS
England
United Kingdom

Phone	+44 (0)20 7836 5454
Email	kch-tr.kms-ctu@nhs.net
Website	http://www.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Industry

Merck Sharp & Dohme Ltd (MSD) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results				No	No

Editorial Notes

17/04/2019: A EudraCT link has been added to the basic results (scientific)
26/08/2016: No publications found, verifying study status with principal investigator