Osteoarthritis Clinical Trial
Official title:
Supportive Tape for Arthritis of the Proximal Interphalangeal Joint: A Two Group Parallel Randomised Placebo Controlled Trial
Verified date | August 2017 |
Source | Mid Yorkshire Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are investigating whether supportive taping of the painful finger joint reduces pain and improves function, and whether this treatment could be used to substitute pain killers, injections or surgery. We hypothesise that supportive finger tape may improve pain, improve the stability of the joint and thereby improve day-to-day hand function too. We will investigate this through a two-group parallel randomised controlled trial whereby one group will receive the treatment taping and the other group will receive a theoretically placebo taping configuration. We will measure pain daily, hand function and adverse events.
Status | Completed |
Enrollment | 44 |
Est. completion date | June 1, 2017 |
Est. primary completion date | June 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: All adult patients (=18 years old) with chronic osteoarthritis of the PIPJ of any finger. Exclusion criteria: Patients meeting any of the below criteria will be excluded: - Patients lacking capacity to consent (unable to understand, retain, weigh up or communicate their decision) - Patients (and/or their carers) who lack the dexterity to cut and apply the Suture Strips to the painful finger. - Patients with active infection or unhealed wounds on the same hand as this may confound the level of pain experienced. - Dermatological conditions or vulnerable dorsal finger skin on the proposed trial finger, which may be exacerbated or damaged respectively by the applicable/removal of tape |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Pinderfields General Hospital | Wakefield |
Lead Sponsor | Collaborator |
---|---|
Mid Yorkshire Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Economic impact | We will speculate and compare the costs of supportive finger tape with other treatments, suggesting its economic feasibility | 3 weeks | |
Primary | Change in Pain | We will measure the change in pain in the trial PIPJ by comparing reported pain without supportive tape over 7 days, to the reported pain over 7 days with supportive tape applied to the finger | 1 week | |
Secondary | Hand Function | Using the Quick-DASH and qualitative means, we will capture whether supportive finger tape affects daily activities and hand function. | 3 weeks | |
Secondary | Adverse outcomes | We will investigate (through quantitative and qualitative means) whether this supportive finger tape caused any adverse events, such as rashes, skin tears or otherwise. | 3 weeks |
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