Evaluation of a care pathway for patients with long-term pain after knee replacement

Conditions

Specialty: Musculoskeletal disorders, Primary sub-specialty: Musculoskeletal pain disorders

Sophie Cole, Sian Noble, Rachael Gooberman‐Hill, Rafael Pinedo‐Villanueva

Cost Effectiveness and Resource Allocation2024-04-11

Better post-operative prediction and management of chronic pain in adults after total knee replacement: the multidisciplinary STAR research programme including RCT

Rachael Gooberman‐Hill, Vikki Wylde, Wendy Bertram, Andrew Moore, Rafael Pinedo‐Villanueva et al. (24 authors)

Programme Grants for Applied Research2023-06-017 citations

10.3310/watm4500

The STAR care pathway for patients with pain at 3 months after total knee replacement: a multicentre, pragmatic, randomised, controlled trial.

Wylde V, Bertram W, Sanderson E, Noble S, Howells N, Peters TJ, Beswick AD, Blom AW, Moore AJ, Bruce J, Walsh DA, Eccleston C, Harris S, Garfield K, White S, Toms A, Gooberman-Hill R, STAR trial group.

2022-01-2830 citations

10.1016/s2665-9913(21)00371-4

Optimising recruitment into trials using an internal pilot

Wendy Bertram, Andrew Moore, Vikki Wylde, Rachael Gooberman‐Hill

Trials2019-04-1115 citations

10.1186/s13063-019-3296-5

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.

Wylde V, Bertram W, Beswick AD, Blom AW, Bruce J, Burston A, Dennis J, Garfield K, Howells N, Lane A, McCabe C, Moore AJ, Noble S, Peters TJ, Price A, Sanderson E, Toms AD, Walsh DA, White S, Gooberman-Hill R.

2018-02-2115 citations

10.1186/s13063-018-2516-8

Interventions

Patients with long-term pain at three months after knee replacement will be randomised with a 2:1 intervention:control randomisation ratio through an online system provided by the Bristol Randomised T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years and over 2. Patients who received a primary total knee replacement for osteoarthritis at a participating NHS Trust 3. Patients who have pain in their operated knee at 2-3 months after surgery, defined as a score of =14 on the 7 pain items of the Oxford Knee Score

Exclusion criteria

Exclusion criteria: 1. Lack of capacity to provide informed consent to participate 2. Previously participating in the STAR trial for contralateral knee 3. Taking part in another research study that interferes unacceptability with STAR (or vice versa)

Design outcomes

Primary

Measure	Time frame
Pain intensity and pain interference are assessed using the Brief Pain Inventory at baseline and 12 months after randomisation.	—

Secondary

Measure	Time frame
1. Pain and physical functioning are measured using the Brief Pain Inventory (at baseline and 6 months) and Oxford Knee Score (OKS) at baseline, 6 and 12 months 2. Pain description is assessed using PainDETECT and Douleur Neuropathique 4 (DN-4) at baseline, 6 and 12 months 3. Emotional aspects of pain are measured using the Hospital Anxiety and Depression Scale (HADs), Pain Catastrophizing Scale (PCS), and Possible Solutions to Pain Questionnaire (PaSol) at baseline, 6 and 12 months 4. Use of pain medications is measured using Resource use questions at baseline, 6 and 12 months 5. Improvement and satisfaction with pain relief is measured using the Self-Administered Patient Satisfaction Scale (single-item question on comparison of pain to pre-operative pain) at baseline, 6 and 12 months 6. Temporal aspects of pain are measured using Single-item questions on pain frequency during past 24 hours and 4 weeks, at baseline, 6 and 12 months 7. Capability is measured using the ICECAP-A at baseline, 6 and 12 months 8. Health-related quality of life is measured using EQ-5D-5L and Short Form-12 (SF-12) at baseline, 6 and 12 months 9. Pain elsewhere is assessed using a body diagram to assess chronic widespread pain at baseline, 6 and 12 months 10. Resource use is measured as use of health services including primary, secondary and tertiary care; use of personal social services; additional costs (travel, lost income, home modifications) using follow-up trial questionnaires at 12 months. Resource use data including inpatient stays and outpatient visits for all patients will be obtained from hospital electronic systems. If this is not possible, they will be extracted from hospital records and recorded on standardised proformas.	—

Measure

Time frame

1. Pain and physical functioning are measured using the Brief Pain Inventory (at baseline and 6 months) and Oxford Knee Score (OKS) at baseline, 6 and 12 months 2. Pain description is assessed using PainDETECT and Douleur Neuropathique 4 (DN-4) at baseline, 6 and 12 months 3. Emotional aspects of pain are measured using the Hospital Anxiety and Depression Scale (HADs), Pain Catastrophizing Scale (PCS), and Possible Solutions to Pain Questionnaire (PaSol) at baseline, 6 and 12 months 4. Use of pain medications is measured using Resource use questions at baseline, 6 and 12 months 5. Improvement and satisfaction with pain relief is measured using the Self-Administered Patient Satisfaction Scale (single-item question on comparison of pain to pre-operative pain) at baseline, 6 and 12 months 6. Temporal aspects of pain are measured using Single-item questions on pain frequency during past 24 hours and 4 weeks, at baseline, 6 and 12 months 7. Capability is measured using the ICECAP-A at baseline, 6 and 12 months 8. Health-related quality of life is measured using EQ-5D-5L and Short Form-12 (SF-12) at baseline, 6 and 12 months 9. Pain elsewhere is assessed using a body diagram to assess chronic widespread pain at baseline, 6 and 12 months 10. Resource use is measured as use of health services including primary, secondary and tertiary care; use of personal social services; additional costs (travel, lost income, home modifications) using follow-up trial questionnaires at 12 months. Resource use data including inpatient stays and outpatient visits for all patients will be obtained from hospital electronic systems. If this is not possible, they will be extracted from hospital records and recorded on standardised proformas.

—

Countries

England, United Kingdom, Wales

Contacts

Public ContactWendy Bertram

wendy.bertram@nbt.nhs.uk+44 117 414 7848

Outcome results

None listed