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Table 1 World Health Organization Trial Registration Data Set

From: Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial

Item number Item Description
1 Primary registry and trial identifying number ISRCTN92545361
2 Date of registration in primary registry 30/08/2016
3 Secondary identifying numbers REC reference: 16/SW/0154 NIHR Programme Grant for Applied Research reference: RP-PG-0613-20,001
4 Sources of monetary or material support NIHR Programme Grant for Applied Research
5 Primary sponsor North Bristol NHS Trust Research and Innovation, Learning and Research Building, Southmead Hospital, Bristol, BS10 5NB Tel: 0117 414 9330 E-mail: research@nbt.nhs.uk
6 Secondary sponsor Not applicable
7 Contact for public queries Wendy Bertram Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol Learning & Research Building, Southmead Hospital, Bristol, BS10 5NB Telephone: 0117 414 7848 E-mail: wendy.bertram@bristol.ac.uk
8 Contact for scientific queries As above
9 Public title Evaluation of a care pathway for patients with long-term pain after knee replacement
10 Scientific title Evaluation of the clinical and cost-effectiveness of a care pathway for patients with chronic pain after total knee replacement: STAR trial
11 Countries of recruitment UK
12 Health condition(s) or problem(s) studied Chronic pain after total knee replacement
13 Intervention(s) Intervention group: One-hour STAR assessment clinic with an Extended Scope Practitioner to identify potential causes of pain and enable onwards referral to appropriate existing services. Up to 6 telephone follow-up calls from the Extended Scope Practitioner over the 12 month follow-up period. Control group: Care as usual
14 Key inclusion and exclusion criteria Age: 18 years or over; no upper age restriction Sex: Male or female Inclusion: Patients who have received a primary total knee replacement because of osteoarthritis at a participating NHS Trust and who report pain in their operated knee at 2–3 months after surgery (score of 0–14 on the Oxford Knee Score pain subscale). Exclusion: A lack of capacity to provide informed consent to participate, previous participation in the STAR trial for the contralateral knee, participation in another research study that interferes unacceptably with the STAR trial
15 Study type Interventional Allocation: Randomised Assignment: parallel Phase III
16 Date of first enrolment October 2016
17 Target sample size 381
18 Recruitment status Recruiting
19 Primary outcomes Pain intensity and pain severity at 12 months after randomisation, measured using the Brief Pain Inventory
20 Key secondary outcomes Brief Pain Inventory at 3 and 6 months after randomisation Oxford Knee Score at 3, 6 and 12 months after randomisation painDETECT at 3, 6 and 12 months after randomisation Douleur Neuropathique 4 at 3, 6 and 12 months after randomisation Hospital Anxiety and Depression Scale at 3, 6 and 12 months after randomisation Pain Catastrophizing Scale at 3, 6 and 12 months after randomisation Possible Solutions to Pain Questionnaire at 3, 6 and 12 months after randomisation Self-Administered Patient Satisfaction Scale at 3, 6 and 12 months after randomisation ICECAP-A at 3, 6 and 12 months after randomisation EQ-5D-5 L at 3, 6 and 12 months after randomisation SF-12 at 3, 6 and 12 months after randomisation