None listed
Conditions
Brief summary
This is a Phase II RCT study that will explore the effects of orthotic intervention in addition to standard therapy on stiff post-traumatic elbows. The purpose of this 6-week trial is to establish the feasibility of proceeding to a larger definitive RCT. This study will also establish the reliability and validity of 2 clinical tools (Modified Weeks Test and Joint End Feel) that will evaluate elbow joint stiffness.
Interventions
A feasibility trial of a double-blinded randomised controlled trial (RCT) design. Participants with extension deficits in the subacute phase of post-traumatic elbow rehabilitation will be randomly allocated to either Treatment A (standard therapy without orthosis) or Treatment B (standard therapy with serial static extension orthosis). Participants in both Treatment A and B will undergo standard therapy, which includes six weekly therapy sessions and have a standardised home exercise program. Therapy sessions are administered by hand therapists (either occupational therapists or physiotherapists) and will last approximately 30-60 minutes. This will include the use of heat packs with weighted stretch, retrograde massage, scar tissue massage and exercises. The standardised home exercise program will done daily, 3-4 times a day. The exercises are progressed weekly as follows: Week 1 and 2 focused on elbow and shoulder ROM; Week 3 and 4 included additional light elbow strengthening exercises (0.5-1kg weights); Week 5 and 6 had ROM exercises, progressively weighted elbow exercises of 1.5-2kg and additional upper body strengthening with an elastic band. However, participants in Treatment B have additional serial static elbow orthoses. These orthoses will be remoulded in more extended positions during the weekly therapy sessions. Whilst this is based on the participant's level of comfort, the aim would be to progress to a fully extended position (0 degrees). The recommended orthotic wear-time is 6-12 hours per day, preferably overnight. Participants will be asked to keep a diary/logbook of their daily exercise and/or orthotic regime.
Sponsors
Study design
Eligibility
Inclusion criteria
- at least 18 years old - 6-8 weeks post elbow trauma - adequate fracture and/or ligamentous stability for passive ROM and use of mobilising orthosis - elbow extension deficit of at least 20 degrees - informed consent obtained - able to comply to weekly review and structured rehabilitation
Exclusion criteria
- Heterotopic ossifications - any inflammatory disease - active infections - wound-healing issues - any neurological conditions (i.e. stroke, multiple sclerosis) - burns-related contractures - total elbow replacement - complex regional pain syndrome or other widespread pain syndromes - patients with cognitive impairments - prior extension splinting