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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