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OsteoarthritisNCT02220374

A RCT of Supportive Finger Tape for PIPJ Osteoarthritis

A study testing Supportive Finger Tape in people with Osteoarthritis, run by Mid Yorkshire Teaching NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Supportive Finger Tape
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2014to 1 Jun 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All adult patients (≥18 years old) with chronic osteoarthritis of the PIPJ of any finger.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Pinderfields General Hospital

    Wakefield, WF1 4DG

Other trials in United Kingdom

About this study

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

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.

Read the 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:

  1. Does supportive taping of the PIPJ of the finger effect functional capability
  2. Does supportive taping of the PIPJ of the finger effect have any significant adverse or undesirable effects
  3. Does supportive taping of the PIPJ of the finger effect represent and economically feasible alternative to other current therapies
  4. Does placebo taping of the PIPJ of the finger effect patient reported pain
  5. Does placebo taping of the PIPJ of the finger effect objective hand function
Conditions
Osteoarthritis
Being tested
Supportive Finger Tape
Keywords
Osteoarthritis, Finger, Supportive, Tape, Pain, Function, Trial
Medical subject headings
Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supportive Finger TapeOther

    Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function

Study groups in NCT02220374
Study groupRoleWhat they receive
Supportive Finger TapeExperimentalParticipants will be randomised to either placebo or supportive taping
Receives: Other: Supportive Finger Tape

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 week

Secondary outcomes (2)
  1. Hand Function

    Using the Quick-DASH and qualitative means, we will capture whether supportive finger tape affects daily activities and hand function.

    Measured: 3 weeks

  2. 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.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion1 Jun 2016
  4. Study completion1 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02220374
Sponsor's protocol ID
14/YH/1040
Status last verified
Aug 2017
First submitted
16 Aug 2014
Last updated
31 Aug 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Supportive Finger Tape in people with Osteoarthritis, run by Mid Yorkshire Teaching NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.

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