None listed
Conditions
Brief summary
This study will be focused on adults 18-65 years who have partially or fully cut a singular tendon used to bend in the fingers and have had this tendon repaired by a surgeon. The study is designed to compare two different types of splints used after a flexor tendon repair. Our primary purpose is to see if one splint allows patients to achieve greater range of movement earlier in their recovery than then other. We hypothesise that a relative motion flexion splint will allow greater early recovery of finger movement compared to a dorsal blocking splint. During this study we will also be comparing when patients can return to work, patients' perceptions of their level of disability, pain, strength and ability to perform their usual activities of daily living. Participants will be randomly assigned to either the relative motion or dorsal blocking splint group. Both groups will receive weekly hand therapy, scar management, education and exercises. Patients will be assessed on the study's primary outcome measure at 3, 6, 8, and 12 weeks and a blinded assessor will review patients at 6 months.
Interventions
Participants in the study will be randomly allocated to either a relative motion flexion orthosis (RMFO) group or a dorsal blocking orthosis control group.
Participants will be administered an orthosis within 3-7 days of tendon repair surgery.
The RMFO group will wear the wrist and yoke components of the splint for 3 weeks full time. Participants will perform daily exercises whilst in their splints
The dorsal wrist component will be weaned daily at 3-5 weeks for light activities and exercises on
Participants in the study will be randomly allocated to either a relative motion flexion orthosis (RMFO) group or a dorsal blocking orthosis control group. Participants will be administered an orthosis within 3-7 days of tendon repair surgery. The RMFO group will wear the wrist and yoke components of the splint for 3 weeks full time. Participants will perform daily exercises whilst in their splints The dorsal wrist component will be weaned daily at 3-5 weeks for light activities and exercises only, the RMO component will continue to be worn full time. Weaning of the splint is not time limited but is limited to activities which are light in loading the flexor tendons. This information and a list of suitable light activities are listed in the handout provided called 'hand tendon repair advice handout'. The dorsal wrist component will be completely weaned at 5-7 weeks. Participants will then be asked to wean the RMO after 7 weeks and commence strengthening and return to usual activities of daily living. Participants in both groups will be advised to avoid heavy lifting and contact sports until 12 week after tendon repair The RMFO group will receive weekly wound care, scar management, education and exercises as part of standard care from their physiotherapist. Wound care will be removal of handy gauze cohesive dressing, skin cleaning with saline solution and reapplication of handy gauze dressing, scar management will be education as per the 'looking after your scar' handout and further education and exercises as per the tendon repair advice and flexor tendon repair early active movement handouts A Physiotherapist working in Hand Therapy will provide education to the participant which will personalised to participants based on their specific injury. Education will include flexor tendon early active movement rehabilitation, involved structures, healing times, warnings, risks and precautions. Handouts provided and discussed are available on the ACT Health intranet and include: Hand Tendon Repair Advice Handout and Flexor Tendon Repair Early Active Movement (0-6 weeks) Handout Looking after your scar Handout The anticipated overall duration of the intervention weekly for the first 8 weeks then follow up at 3 and 6 months after tendon repair. Interventions will be administered by and Senior Physiotherapist working in Hand Therapy with a minimum of 3 years experience Compliance with orthosis wear, exercises and attendance with hand therapy will be discussed and recorded in a study-specific questionnaire weekly during the first 8 weeks of intervention.
Sponsors
ACT Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Male or females aged between 18-65 years. Single digit sharp laceration injury of 1-2 FDP and/or FDS greater which is greater or equal to 50%. Single or no digital nerve or vessel involved. English speaking. Able to attend weekly hand therapy appointments. Able to complete early active movement regime as decided by the surgeon or hand therapist. Digits 2-5 only. Pulley venting at the discretion of the surgeon.
Exclusion criteria
Thumb tendon injuries Previous hand injury or impairment that significantly affects ROM and/or function. Non-English speaking Multiple digital nerve and vessels involved.
Outcome results
None listed