Feasibility of conducting a cohort randomised controlled trial assessing the effectiveness of a nurse-led package of care for knee pain.
Rheumatology (Oxford)
; 2023 Aug 23.
Article
em En
| MEDLINE
| ID: mdl-37610332
ABSTRACT
OBJECTIVE:
To evaluate the feasibility of conducting a cohort randomised-controlled trial (RCT) of a nurse-led package of care for knee pain and determine treatment sequence for use in a future trial.METHODS:
Open label, three-arm, single-centre, mixed-methods, feasibility cohort RCT. Adults aged ≥40 years with moderate-to-severe knee pain for ≥3 months were eligible. Participants were randomised into groups A (non-pharmacological treatment first), B (pharmacological treatment first), or group C (usual care). The intervention was delivered over 26-weeks. Outcomes were dropout rate, recruitment rate, intervention fidelity, ability to collect outcome data and treatment acceptability.RESULTS:
Seventeen participants were randomised and enrolled into each of groups A and B (5.2% recruitment rate), and 174 randomised to group C. Participant characteristics at randomisation were comparable across the three arms. COVID-19 paused the study from March-November-2020. Participants enrolled in groups A and B before March-2020 were withdrawn at restart. Of the 20 participants enrolled after restart, 18 completed the study (10% dropout). The nurse reported delivering most aspects of the intervention with high fidelity. Participants viewed the package of care as structured, supportive and holistic, they learnt about self-managing knee pain, and could engage with and follow the non-pharmacological treatment. Most found the non-pharmacological treatment more useful than the pharmacological treatment, preferring to receive it before or alongside analgesia. Many self-reported questionnaires were not fully completed.CONCLUSIONS:
The nurse-led package of care for knee pain was acceptable with low dropout, although the cohort RCT design may not be feasible for a definitive trial. TRIAL REGISTRATION clinicaltrials.gov; NCT03670706.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Qualitative_research
Idioma:
En
Revista:
Rheumatology (Oxford)
Assunto da revista:
REUMATOLOGIA
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Reino Unido