<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/NCT03839901</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 218328</org_study_id>
    <nct_id>NCT03839901</nct_id>
  </id_info>
  <brief_title>Rehabilitation Programmes for Scapholunate Instability</brief_title>
  <official_title>A Pilot Study to Investigate Two Different Physiotherapy Rehabilitation Programmes, to Treat the Conservatively Managed Scapholunate Instability.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bradford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bradford Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Bradford</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two different exercises approaches were tested in patients with Scapho-Lunate (SL)&#xD;
      instability; one to strengthen the tendons in static positions and the other to strengthen&#xD;
      the tendons whilst the wrist is moving.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex&#xD;
      to diagnose and is often missed entirely. The natural progression of SL instability has been&#xD;
      suggested to lead to osteoarthritis. The management of SL instability can be broadly divided&#xD;
      into conservative and surgical, with the former being the first option taken by most medical&#xD;
      professionals, which primarily involves physiotherapy. The evidence base for physiotherapy&#xD;
      management of SL instability is limited; however cadaver research has identified loading some&#xD;
      of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as&#xD;
      to whether this clinically makes any difference to the patients symptoms, or how to do it.&#xD;
      This research therefore aimed to test the protocol and methods, and act as a platform for&#xD;
      larger studies, to investigate this.&#xD;
&#xD;
      Two different exercises approaches were tested; one to strengthen the tendons in static&#xD;
      positions and the other to strengthen the tendons whilst the wrist is moving.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    There were insufficient numbers recruited before the end of the student project&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Grip strength using E-link dynamometer</measure>
    <time_frame>assessed at 0, 4 and 8 weeks</time_frame>
    <description>change of grip strength from baseline change of 20% in kg considered signifcant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>numerical rating scale</measure>
    <time_frame>assessed at 0, 4 and 8 weeks</time_frame>
    <description>Pain scored on a numerical rating scale 0 (no pain) -10 (unbearable pain) Minimally Clinical Important Difference of 20mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Rated Wrist Evaluation</measure>
    <time_frame>assessed at 0, 4 and 8 weeks</time_frame>
    <description>Used Patient Rated Wrist Evaluation PRWE questionnaire (A score of 100 represents the worst functional score, whereas 0 represents no disability) with Minimally Clinical Important Difference of 14 points</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Wrist Strain</condition>
  <condition>Wrist Sprain</condition>
  <condition>Scaphoid-Lunate Instability</condition>
  <arm_group>
    <arm_group_label>isometric training programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isotonic training programme</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home exercise program</intervention_name>
    <description>Home exercise programme with participants followed up at week 1, 4, 6 and 8.</description>
    <arm_group_label>isometric training programme</arm_group_label>
    <arm_group_label>isotonic training programme</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages eighteen to sixty,&#xD;
&#xD;
          -  wrist pain,&#xD;
&#xD;
          -  confirmed scapholunate ligament disruption on MRA or XR (partial or full),&#xD;
&#xD;
          -  referred from orthopaedic wrist specialist,&#xD;
&#xD;
          -  for conservative management,&#xD;
&#xD;
          -  consent to trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under eighteen or over sixty years,&#xD;
&#xD;
          -  previous fracture,&#xD;
&#xD;
          -  degenerative changes in the wrist,&#xD;
&#xD;
          -  previous surgery,&#xD;
&#xD;
          -  complex regional pain syndrome or diagnosis of rheumatological conditions,&#xD;
&#xD;
          -  no wrist injection in preceding twelve months or other wrist conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <state>West Yorkshire</state>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scaphoid-Lunate</keyword>
  <keyword>instability</keyword>
  <keyword>wrist</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03839901
org study id: IRAS 218328
nct id: NCT03839901
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two different exercises approaches were tested in patients with Scapho-Lunate (SL)
      instability; one to strengthen the tendons in static positions and the other to strengthen
      the tendons whilst the wrist is moving.
Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex
      to diagnose and is often missed entirely. The natural progression of SL instability has been
      suggested to lead to osteoarthritis. The management of SL instability can be broadly divided
      into conservative and surgical, with the former being the first option taken by most medical
      professionals, which primarily involves physiotherapy. The evidence base for physiotherapy
      management of SL instability is limited; however cadaver research has identified loading some
      of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as
      to whether this clinically makes any difference to the patients symptoms, or how to do it.
      This research therefore aimed to test the protocol and methods, and act as a platform for
      larger studies, to investigate this.

      Two different exercises approaches were tested; one to strengthen the tendons in static
      positions and the other to strengthen the tendons whilst the wrist is moving.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Grip strength using E-link dynamometer
time frame: assessed at 0, 4 and 8 weeks
description: change of grip strength from baseline change of 20% in kg considered signifcant
measure: numerical rating scale
time frame: assessed at 0, 4 and 8 weeks
description: Pain scored on a numerical rating scale 0 (no pain) -10 (unbearable pain) Minimally Clinical Important Difference of 20mm
measure: Patient Rated Wrist Evaluation
time frame: assessed at 0, 4 and 8 weeks
description: Used Patient Rated Wrist Evaluation PRWE questionnaire (A score of 100 represents the worst functional score, whereas 0 represents no disability) with Minimally Clinical Important Difference of 14 points
arm group label: isometric training programme
arm group type: Experimental
description: 'Home exercise programme' consisting of isometric exercises with participants followed up at week 1, 4, 6 and 8.
arm group label: isotonic training programme
arm group type: Experimental
description: 'Home exercise programme' consisting of isotonic exercises with participants followed up at week 1, 4, 6 and 8.
intervention type: Other
intervention name: Home exercise program
description: Home exercise programme with participants followed up at week 1, 4, 6 and 8.
arm group label: isometric training programme
arm group label: isotonic training programme
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No