<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02220374</url>
  </required_header>
  <id_info>
    <org_study_id>14/YH/1040</org_study_id>
    <nct_id>NCT02220374</nct_id>
  </id_info>
  <brief_title>A RCT of Supportive Finger Tape for PIPJ Osteoarthritis</brief_title>
  <official_title>Supportive Tape for Arthritis of the Proximal Interphalangeal Joint: A Two Group Parallel Randomised Placebo Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mid Yorkshire Teaching NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mid Yorkshire Teaching NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oesteoarthritis of the joints of the finger(s) is a common problem. The first-line treatment&#xD;
      involves pain killers taken either as tablets, gels, or patches. Secondly, some joints are&#xD;
      amenable to injections of steroids and anaesthetic agents. Finally, as a last resort, some&#xD;
      joints may be fused or replaced with prosthetic joints by Hand Surgeons. We are investigating&#xD;
      whether supportive taping of the painful finger joint reduces pain and improves function, and&#xD;
      whether this treatment could be used to substitute pain killers, injections or surgery. We&#xD;
      hypothesise that supportive finger tape may improve pain, improve the stability of the joint&#xD;
      and thereby improve day-to-day hand function too. We will investigate this through a&#xD;
      two-group parallel randomised controlled trial whereby one group will receive the treatment&#xD;
      taping and the other group will receive a theoretically placebo taping configuration. We will&#xD;
      measure pain daily, hand function and adverse events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Osteoarthritis (OA) of the interphalangeal joints of the hand is the most common age-related&#xD;
      joint disorder worldwide, affecting the hand(s) of up to 67% of the elderly population. At&#xD;
      least 18.2% of such patients have OA of at least one proximal interphalangeal joint involved&#xD;
      and it is the second leading cause of hand pain after osteoarthritis of the thumb&#xD;
      carpometacarpal joint. In the UK, 3% of the population seek medical attention for the&#xD;
      symptoms of their hand arthritis, with the main complaints being pain, reduced grip strength,&#xD;
      functional limitations with day-today activities (eg. dressing, eating and drinking, taking&#xD;
      medication, writing, etc), stiffness and deformity.&#xD;
&#xD;
      Currently, the treatment of osteoarthritis of the finger joints is limited to four different&#xD;
      avenues which carry their own limitation(s) and potential complications. Firstly,&#xD;
      conservative measures such as physiotherapy with or without splints and compression garments,&#xD;
      alterations in the execution of daily activities and avoidance of environmental triggers (eg.&#xD;
      cold and wet weather) - these carry substantial time commitments and interference with normal&#xD;
      life. Secondly, analgesics either by the oral, transcutaneous or topical routes may be used -&#xD;
      these medication may cause drowsiness, confusion, constipation, collapse, kidney injury,&#xD;
      stomach ulcers and bleeding, as well as other undesirable effects which may in-turn&#xD;
      precipitate life-threatening illnesses. Thirdly, joints may be injected with steroids and&#xD;
      anaesthetic agents which is both diagnostic and therapeutic - however, this too carries risks&#xD;
      of septic arthritis, tendon attrition and paradoxical exacerbation of symptoms. Finally,&#xD;
      surgery may be offered to either replace the joint with a prosthesis or fuse it with metal&#xD;
      screw(s) and wire(s) - surgery carries significant risk of infection and damage to vessels or&#xD;
      nerves, which may render the finger useless or even lead to amputation.&#xD;
&#xD;
      With the current available treatments carrying significant limitations, we have&#xD;
      conceptualised a treatment which confers minimal (no proven) risk and may be of benefit to&#xD;
      some individuals based on a current theorised treatment of supportive taping. The Kinesio®&#xD;
      taping system is a well-known product used by many athletes to support their joints and&#xD;
      improve performance. The elasticated latex tape is applied to the skin overlying a joint, in&#xD;
      a specific orientation in order to provide theoretical benefits including: physical support&#xD;
      for misaligned joints, increased recoil of the joint back to the anatomical position, and&#xD;
      reduce swelling by improving lymphatic flow. A recent systematic review concluded that the&#xD;
      most significant benefit from Kinesio® taping was reduced pain in large joints (eg. shoulder,&#xD;
      knee and ankle). The reason for this is not well understood but may be related to stimulation&#xD;
      of cutaneous and peri-articular mechanoreceptors, physically re-aligned/support of the joint&#xD;
      surface or a placebo effect.&#xD;
&#xD;
      At present, the Kinesio® system is not ideal for patients with finger joint osteoarthritis&#xD;
      for two reasons - there is no commercially available tape which is small enough to apply to&#xD;
      the finger and the latex component may prevent some patients from using it. However, a latex&#xD;
      free substitute is readily available in the hospital setting, which has similar properties&#xD;
      (ie. adhesive and elasticated) which is safe and cheaper - Suture Strips® by Derma Sciences™.&#xD;
&#xD;
      Research on normal healthy subjects has shown that supportive taping of fingers improves&#xD;
      perceived grip strength. Further, in patients with injured fingers, supportive taping&#xD;
      increases actual grip strength in particular positions/actions. We know that patients with&#xD;
      painful thumb joints benefit from supportive taping as it improves their joint alignment and&#xD;
      therefore function. However, to-date there have been no studies on the role of finger PIPIJ&#xD;
      taping to reduce the pain of arthritis. We hypothesise that by transferring the proven&#xD;
      benefits of supportive taping on other bodily regions (ie. pain reduction, improved joint&#xD;
      alignment, mechanical support as well as other undefined benefits) that patients may benefit&#xD;
      from supportive taping of the PIPJ of the finger.&#xD;
&#xD;
      Rationale:&#xD;
&#xD;
      The current treatment modalities for finger joint arthritis carry significant risk of&#xD;
      undesirable and potentially dangerous complications. We propose a simple method of supportive&#xD;
      taping which may improve patient's pain and function, within conferring the risk of adverse&#xD;
      events.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      We aim to investigate the effectiveness of supportive tape on the perceived pain of PIPJ&#xD;
      osteoarthritis in a single digit of one hand. We also aim to investigate its impact on hand&#xD;
      function and will undertake an economic analysis in comparison to current available&#xD;
      treatments.&#xD;
&#xD;
      Type of study:&#xD;
&#xD;
      A pragmatic blocked two-group parallel randomised placebo controlled trial.&#xD;
&#xD;
      Research questions:&#xD;
&#xD;
      Primary research question;&#xD;
&#xD;
      1. Does supportive taping of the PIPJ of the finger effect perceived pain&#xD;
&#xD;
      Secondary research questions:&#xD;
&#xD;
        1. Does supportive taping of the PIPJ of the finger effect functional capability&#xD;
&#xD;
        2. Does supportive taping of the PIPJ of the finger effect have any significant adverse or&#xD;
           undesirable effects&#xD;
&#xD;
        3. Does supportive taping of the PIPJ of the finger effect represent and economically&#xD;
           feasible alternative to other current therapies&#xD;
&#xD;
        4. Does placebo taping of the PIPJ of the finger effect patient reported pain&#xD;
&#xD;
        5. Does placebo taping of the PIPJ of the finger effect objective hand function&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain</measure>
    <time_frame>1 week</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hand Function</measure>
    <time_frame>3 weeks</time_frame>
    <description>Using the Quick-DASH and qualitative means, we will capture whether supportive finger tape affects daily activities and hand function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse outcomes</measure>
    <time_frame>3 weeks</time_frame>
    <description>We will investigate (through quantitative and qualitative means) whether this supportive finger tape caused any adverse events, such as rashes, skin tears or otherwise.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Economic impact</measure>
    <time_frame>3 weeks</time_frame>
    <description>We will speculate and compare the costs of supportive finger tape with other treatments, suggesting its economic feasibility</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Supportive Finger Tape</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomised to either placebo or supportive taping</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supportive Finger Tape</intervention_name>
    <description>Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function</description>
    <arm_group_label>Supportive Finger Tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        All adult patients (≥18 years old) with chronic osteoarthritis of the PIPJ of any finger.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients meeting any of the below criteria will be excluded:&#xD;
&#xD;
          -  Patients lacking capacity to consent (unable to understand, retain, weigh up or&#xD;
             communicate their decision)&#xD;
&#xD;
          -  Patients (and/or their carers) who lack the dexterity to cut and apply the Suture&#xD;
             Strips to the painful finger.&#xD;
&#xD;
          -  Patients with active infection or unhealed wounds on the same hand as this may&#xD;
             confound the level of pain experienced.&#xD;
&#xD;
          -  Dermatological conditions or vulnerable dorsal finger skin on the proposed trial&#xD;
             finger, which may be exacerbated or damaged respectively by the applicable/removal of&#xD;
             tape&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Southern, MBBS FRCS(Plast)</last_name>
    <role>Study Director</role>
    <affiliation>Pinderfields General Hospital, Wakefield</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinderfields General Hospital</name>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mid Yorkshire Teaching NHS Trust</investigator_affiliation>
    <investigator_full_name>Ryckie Wade</investigator_full_name>
    <investigator_title>Core Surgical Trainee</investigator_title>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Finger</keyword>
  <keyword>Supportive</keyword>
  <keyword>Tape</keyword>
  <keyword>Pain</keyword>
  <keyword>Function</keyword>
  <keyword>Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02220374
org study id: 14/YH/1040
nct id: NCT02220374
lead sponsor: 
has dmc: No
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.
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain
time frame: 1 week
description: 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
measure: Hand Function
time frame: 3 weeks
description: Using the Quick-DASH and qualitative means, we will capture whether supportive finger tape affects daily activities and hand function.
measure: Adverse outcomes
time frame: 3 weeks
description: We will investigate (through quantitative and qualitative means) whether this supportive finger tape caused any adverse events, such as rashes, skin tears or otherwise.
measure: Economic impact
time frame: 3 weeks
description: We will speculate and compare the costs of supportive finger tape with other treatments, suggesting its economic feasibility
arm group label: Supportive Finger Tape
arm group type: Experimental
description: Participants will be randomised to either placebo or supportive taping
intervention type: Other
intervention name: Supportive Finger Tape
description: Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function
arm group label: Supportive Finger Tape
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephen Southern, MBBS FRCS(Plast)
role: Study Director
affiliation: Pinderfields General Hospital, Wakefield
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Mid Yorkshire Teaching NHS Trust
investigator full name: Ryckie Wade
investigator title: Core Surgical Trainee
mesh term: Osteoarthritis