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The conservative management of stiffness and contractures in post-traumatic elbows

The efficacy of standard therapy with serial static extension orthoses versus standard treatment without orthoses on range of motion (ROM) and functional outcomes in post-traumatic elbow rehabilitation: a feasibility study of a randomised controlled trial

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001402134
Enrollment
4
Registered
2019-10-14
Start date
2020-07-01
Completion date
2021-10-28
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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. Th

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

Chew Aik Sim
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026