Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial
Objective: The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder. Design: Multicentre, randomised feasibilit...
| Автори: | , , , , , , , , , , |
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| Формат: | Journal article |
| Мова: | English |
| Опубліковано: |
BMJ Publishing Group
2024
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| _version_ | 1826314822345555968 |
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| author | Hopewell, S Srikesavan, C Evans, A Er, F Rangan, A Preece, J Francis, A Massa, MS Feldmann, M Lamb, S Nanchahal, J |
| author_facet | Hopewell, S Srikesavan, C Evans, A Er, F Rangan, A Preece, J Francis, A Massa, MS Feldmann, M Lamb, S Nanchahal, J |
| author_sort | Hopewell, S |
| collection | OXFORD |
| description | Objective: The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder. Design: Multicentre, randomised feasibility trial, with embedded qualitative study. Setting: Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services. Participants: Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder. Interventions: Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later. Primary feasibility objectives: (1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months. Results: Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%. Conclusion: This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment. Trial registration number: ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214). |
| first_indexed | 2024-09-25T04:16:37Z |
| format | Journal article |
| id | oxford-uuid:259f5d71-a365-4c5c-94cb-917f335bcc38 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-12-09T03:13:54Z |
| publishDate | 2024 |
| publisher | BMJ Publishing Group |
| record_format | dspace |
| spelling | oxford-uuid:259f5d71-a365-4c5c-94cb-917f335bcc382024-10-16T09:30:00ZAnti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:259f5d71-a365-4c5c-94cb-917f335bcc38EnglishJisc Publications RouterBMJ Publishing Group2024Hopewell, SSrikesavan, CEvans, AEr, FRangan, APreece, JFrancis, AMassa, MSFeldmann, MLamb, SNanchahal, JObjective: The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder. Design: Multicentre, randomised feasibility trial, with embedded qualitative study. Setting: Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services. Participants: Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder. Interventions: Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later. Primary feasibility objectives: (1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months. Results: Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%. Conclusion: This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment. Trial registration number: ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214). |
| spellingShingle | Hopewell, S Srikesavan, C Evans, A Er, F Rangan, A Preece, J Francis, A Massa, MS Feldmann, M Lamb, S Nanchahal, J Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title | Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title_full | Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title_fullStr | Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title_full_unstemmed | Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title_short | Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial |
| title_sort | anti tnf adalimumab injection for the treatment of pain predominant early stage frozen shoulder the anti freaze feasibility randomised controlled trial |
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