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Clinical Trials/NCT02220374
NCT02220374CompletedNot Applicable

Supportive Tape for Arthritis of the Proximal Interphalangeal Joint: A Two Group Parallel Randomised Placebo Controlled Trial

Mid Yorkshire Teaching NHS Trust2 sites in 1 country44 target enrollmentStarted: November 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
44
Locations
2
Primary Endpoint
Change in Pain

Study Overview

Brief Summary

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.

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™.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Supportive Finger Tape

Experimental

Participants will be randomised to either placebo or supportive taping

Intervention: Supportive Finger Tape (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Hand Function(3 weeks)
  • Adverse outcomes(3 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ryckie Wade

Core Surgical Trainee

Mid Yorkshire Teaching NHS Trust

Study Sites (2)

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