Dataset Information

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

ABSTRACT:

Background

Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap.

Methods

FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness.

Discussion

FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes.

Trial registration

ISRCTN: 10236011.

SUBMITTER: Bamford E

PROVIDER: S-EPMC10943783 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

Bamford Emma E Berntsson Hannah H Beale Suzanne S Desoysa Lauren L Dias Joseph J Hamer-Kiwacz Sienna S Hind Daniel D Johnson Nick N Loban Amanda A Molloy Kaye K Morvan Emma E Rombach Ines I Selby Anna A Thokala Praveen P Turtle Chris C Walters Stephen S Drummond Avril A

Trials 20240316 1

<h4>Background</h4>Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion ...[more]

PMID: 38493121

Similar Datasets

Project description:PurposeThe aims of this retrospective cohort study were to present outcomes of zone 2 and 3 primary flexor tendon repairs and to evaluate how clinical outcomes change over time within and between zones of injury at weeks 6, 13, and 26.MethodsData were retrieved from a multicenter flexor tendon cohort registry from 2014 to 2021. The inclusion criteria were: (1) adult patients after primary flexor tendon surgery in zone 2 or 3, (2) flexor digitorum profundus laceration of >50%, (3) 4-6 multistrand flexor digitorum profundus core suture, and (4) early active motion protocol. The primary outcome was the range of motion. Secondary outcomes were strength, patient satisfaction on an 11-point Likert scale, and self-reported physical function measured with the Disability of the Arm, Shoulder, and Hand questionnaire 6, 13, and 26 weeks after surgery.ResultsWe evaluated 33 patients after 39 tendon repairs in zone 3 and 174 repairs in zone 2 of 163 patients. Range of motion significantly improved over time in both zones (P < .001 to .01). Between-group range of motion differences were nonsignificant except for week 26 (P < .001) for the zone 3 group. Hand strength significantly improved in both zones over time (P < .001 to .01), while between-zone strength differences were statistically nonsignificant (P = .37 to .93). Patient satisfaction was generally good to high (mean 6.8 to 8.0 points) with significant within-group changes in both zones (P < .001). There were no relevant between-zone differences in Disability of the Arm, Shoulder, and Hand scores at any time point.ConclusionsPatients had significantly improved clinical outcomes in both zones. The zone of injury significantly affected the total active motion scores at the final assessment after 26 weeks for the zone 3 injuries. For the secondary outcomes hand strength, patient satisfaction, and Disability of the Arm, Shoulder, and Hand scores, we discovered no significant between-group differences.Type of study/level of evidenceTherapeutic IV.

Project description:BackgroundEvidence supports the use of hand-based metacarpophalangeal joint (MCPJ) blocking splints as an intervention for trigger finger (TF). In practice, finger-based relative motion (RM) splints are also implemented without evidence.PurposeThis randomized comparative trial (RCT) aims to evaluate implementation of MCPJ blocking and RM splints for effectiveness, function, occupational performance and wearability after 6 weeks of TF management.Methods and analysisPriori analysis determined 36 individuals were needed for random assignment to the RM or MCPJ blocking splint groups. Individuals must be aged ≥21 years, and diagnosed with TF involving ≥1 finger. For blinding purposes, the primary author screens for eligibility, fabricates the splints and educates. Therapist A administers the primary outcome measures Week-1 and Week-6-stage of stenosing tenosynovitis and secondary outcome measures- number of triggering events in 10 active fists, visual analog scales (VAS) for pain, splint comfort and satisfaction, Disabilities of the Arm, Shoulder and Hand, and Canadian Occupational Performance Measure. Therapist B in Week-3 instructs participants in deep tissue massage and administers splint wearability VASs. The RM pencil test is used to determine the affected finger(s) MCPJ splint position i.e., more extension or flexion based on participant response. The MCPJ blocking splint holds the MCPJ in a neutral position. Analysis involves a mixed-effects ANOVA to compare Week-1 and Week-6 primary and secondary outcomes.ResultsRecruitment and data collection are ongoing.DiscussionBiomechanically RM splints control tendon excursion and reduce passive tendon tension while allowing unencumbered finger motion and hand function. Hence clinicians use RM splints as an intervention for TF, despite the lack of implementation evidence. This RCT implements a function-focused as well as patient-centered approach with partial blinding of assessors and participants.ConclusionWe anticipate that this study will provide evidence for the implementation of RM splints to manage adults with TF.Trial registrationClinical trial registration This trial is registered with ClinicalTrials.gov (NCT05763017).

Project description:Adhesion formation after flexor tendon repair remains a clinical problem. Early postoperative motion after tendon repair has been demonstrated to reduce adhesion formation while increasing tendon strength. It is hypothesized that during mobilization, tendon cells experience mechanical shear forces that alter their biology in a fashion that reduces scar formation but also activates key genes involved in tendon healing. To test this hypothesis, primary intrinsic tenocyte cultures were established from flexor tendons of 20 Sprague-Dawley rats and sheared at 50 rpm (0.41 Pa) using a cone viscometer for 6 and 12 hours. Total RNA was harvested and compared with time-matched unsheared controls using cDNA microarrays and Northern blot analysis. Microarray analysis demonstrated that mechanical shear stress induced an overall "antifibrotic" expression pattern with decreased transcription of collagen type I and collagen type III. Shear stress down-regulated profibrotic molecules in the platelet-derived growth factor, insulin-like growth factor, and fibroblast growth factor signaling pathways. In addition, shear stress induced an overall decrease in transforming growth factor (TGF)-beta signaling pathway molecules with down-regulation of TGF-beta2, TGF-beta3, TGF-RI, and TGF-RII expression. Moreover, sheared tendon cells increased expression of matrix metalloproteinases and decreased expression of tissue inhibitors of metalloproteinase, an expression pattern consistent with an antifibrotic increase in extracellular matrix degradation. However, up-regulation of genes implicated in tendon healing, specifically, vascular endothelial growth factor-A and several bone morphogenetic proteins. Interestingly, the known mechanoresponsive gene, TGF-beta1, also implicated in tendon healing, was differentially up-regulated by shear stress. Northern blot validation of our results for TGF-beta1, TGF-beta2, TGF-beta3, and collagen type I demonstrated direct correlation with microarray data. Groups of assays that are related as part of a time series. Keywords: time_series_design

Dataset Information

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

Background

Methods

Discussion

Trial registration

Publications

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs.

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