Plain English Summary
Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. In some, movement can be limited so severely that they need to use walking aids such as crutches to get around. Using forearm walking aids (crutches that attach at the forearm) often leads to pain in the forearms. Special handles called anatomic handles have been developed to increase the size of the contact area and reduce the pressure, but for many this is ineffective. One third of the load is transferred via the forearm. In contrast to the hand, the ulnar (outer, lower arm bone) is not well protected and this can often lead to compression of the ulna nerve, leading to pain. This study aims to look at the effectiveness of a newly developed anatomic cuff for forearm crutches which aims to protect the ulnar bone and distributing the load towards surrounding muscles and soft tissue.
Who can participate?
Patients with OA who have used forearm crutches on both sides for at least eight weeks.
What does the study involve?
All participants are given the special crutches with the anatomic cuff to use for four weeks. The length of the crutches is adjusted depending on participant height. At the start of the study and then after four weeks, participants complete questionnaires to assess their forearm pain and general helath.
What are the possible benefits and risks of participating?
Participants may benefit from lower pain levels in their forearms than if they used conventional crutches. There are no notable risks involved with participating.
Where is the study run from?
University Hospital Basel (Switzerland)
When is the study starting and how long is it expected to run for?
January 2014 to December 2016
Who is funding the study?
University Hospital Basel (Switzerland)
Who is the main contact?
Professor Thomas Hügle
thomas.huegle@unibasl.ch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014/1
Study information
Scientific title
Prospective clinical evaluation of a novel anatomic cuff for forearm crutches in patients with osteoarthritis
Acronym
Study hypothesis
Anatomic cuffs with ulnar protection are less associated with pain and discomfort in long-term users of forearm crutches.
Ethics approval
Ethikkomission beider Basel (EKBB) Switzerland, 03/06/2014, ref: E350/12
Study design
Prospective non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Osteoarthritis
Intervention
At baseline, all participants receive forearm crutches with an anatomic cuff (Ulnar Pro®, Rebotec, Quakenbrück, Germany) with anatomic hand grip (model soft, Rebotec, Quakenbrück, Germany) to use for four weeks. The length of the crutches are adjusted by the study team to the patients’ hand height during stance with the arms positioned at 20 to 30° elbow flexion. Clinical data are collected at baseline and at 4-weeks follow-up using questionnaires.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Pain along the forearm is measured using a questionnaire based on a unipolar 9-point Likert-scale designed for the purpose of this study at baseline and 4 weeks
Secondary outcome measures
General health is assessed using 36-Item Short Form Survey (SF-36) at baseline and 4 weeks
Overall trial start date
01/01/2014
Overall trial end date
31/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Suffering from osteoarthritis
2. Have used bilateral forearm crutches for at least 8 weeks prior to the study
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Infections of hands or forearms
2. Amputation
3. Neuropathy (e.g. due to diabetes or syringomyely)
4. Active rheumatic diseases
5. Upper limp injuries
Recruitment start date
01/03/2014
Recruitment end date
01/10/2014
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Basel
Petersgraben 4
Basel
4045
Switzerland
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Basel
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Thomas.huegle@unibas.ch
Intention to publish date
31/12/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28292295