- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220374
A RCT of Supportive Finger Tape for PIPJ Osteoarthritis
Supportive Tape for Arthritis of the Proximal Interphalangeal Joint: A Two Group Parallel Randomised Placebo Controlled Trial
Study Overview
Detailed Description
Introduction:
Osteoarthritis (OA) of the interphalangeal joints of the hand is the most common age-related joint disorder worldwide, affecting the hand(s) of up to 67% of the elderly population. At least 18.2% of such patients have OA of at least one proximal interphalangeal joint involved and it is the second leading cause of hand pain after osteoarthritis of the thumb carpometacarpal joint. In the UK, 3% of the population seek medical attention for the symptoms of their hand arthritis, with the main complaints being pain, reduced grip strength, functional limitations with day-today activities (eg. dressing, eating and drinking, taking medication, writing, etc), stiffness and deformity.
Currently, the treatment of osteoarthritis of the finger joints is limited to four different avenues which carry their own limitation(s) and potential complications. Firstly, conservative measures such as physiotherapy with or without splints and compression garments, alterations in the execution of daily activities and avoidance of environmental triggers (eg. cold and wet weather) - these carry substantial time commitments and interference with normal life. Secondly, analgesics either by the oral, transcutaneous or topical routes may be used - these medication may cause drowsiness, confusion, constipation, collapse, kidney injury, stomach ulcers and bleeding, as well as other undesirable effects which may in-turn precipitate life-threatening illnesses. Thirdly, joints may be injected with steroids and anaesthetic agents which is both diagnostic and therapeutic - however, this too carries risks of septic arthritis, tendon attrition and paradoxical exacerbation of symptoms. Finally, surgery may be offered to either replace the joint with a prosthesis or fuse it with metal screw(s) and wire(s) - surgery carries significant risk of infection and damage to vessels or nerves, which may render the finger useless or even lead to amputation.
With the current available treatments carrying significant limitations, we have conceptualised a treatment which confers minimal (no proven) risk and may be of benefit to some individuals based on a current theorised treatment of supportive taping. The Kinesio® taping system is a well-known product used by many athletes to support their joints and improve performance. The elasticated latex tape is applied to the skin overlying a joint, in a specific orientation in order to provide theoretical benefits including: physical support for misaligned joints, increased recoil of the joint back to the anatomical position, and reduce swelling by improving lymphatic flow. A recent systematic review concluded that the most significant benefit from Kinesio® taping was reduced pain in large joints (eg. shoulder, knee and ankle). The reason for this is not well understood but may be related to stimulation of cutaneous and peri-articular mechanoreceptors, physically re-aligned/support of the joint surface or a placebo effect.
At present, the Kinesio® system is not ideal for patients with finger joint osteoarthritis for two reasons - there is no commercially available tape which is small enough to apply to the finger and the latex component may prevent some patients from using it. However, a latex free substitute is readily available in the hospital setting, which has similar properties (ie. adhesive and elasticated) which is safe and cheaper - Suture Strips® by Derma Sciences™.
Research on normal healthy subjects has shown that supportive taping of fingers improves perceived grip strength. Further, in patients with injured fingers, supportive taping increases actual grip strength in particular positions/actions. We know that patients with painful thumb joints benefit from supportive taping as it improves their joint alignment and therefore function. However, to-date there have been no studies on the role of finger PIPIJ taping to reduce the pain of arthritis. We hypothesise that by transferring the proven benefits of supportive taping on other bodily regions (ie. pain reduction, improved joint alignment, mechanical support as well as other undefined benefits) that patients may benefit from supportive taping of the PIPJ of the finger.
Rationale:
The current treatment modalities for finger joint arthritis carry significant risk of undesirable and potentially dangerous complications. We propose a simple method of supportive taping which may improve patient's pain and function, within conferring the risk of adverse events.
Aims:
We aim to investigate the effectiveness of supportive tape on the perceived pain of PIPJ osteoarthritis in a single digit of one hand. We also aim to investigate its impact on hand function and will undertake an economic analysis in comparison to current available treatments.
Type of study:
A pragmatic blocked two-group parallel randomised placebo controlled trial.
Research questions:
Primary research question;
1. Does supportive taping of the PIPJ of the finger effect perceived pain
Secondary research questions:
- Does supportive taping of the PIPJ of the finger effect functional capability
- Does supportive taping of the PIPJ of the finger effect have any significant adverse or undesirable effects
- Does supportive taping of the PIPJ of the finger effect represent and economically feasible alternative to other current therapies
- Does placebo taping of the PIPJ of the finger effect patient reported pain
- Does placebo taping of the PIPJ of the finger effect objective hand function
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Wakefield, United Kingdom, WF1 4DG
- Pinderfields General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Supportive Finger Tape
Participants will be randomised to either placebo or supportive taping
|
Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain
Time Frame: 1 week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand Function
Time Frame: 3 weeks
|
Using the Quick-DASH and qualitative means, we will capture whether supportive finger tape affects daily activities and hand function.
|
3 weeks
|
Adverse outcomes
Time Frame: 3 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Economic impact
Time Frame: 3 weeks
|
We will speculate and compare the costs of supportive finger tape with other treatments, suggesting its economic feasibility
|
3 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Stephen Southern, MBBS FRCS(Plast), Pinderfields General Hospital, Wakefield
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/YH/1040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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