[x_section parallax=”false” bg_image=”https://reconstructivesurgerytrials.net/wp-content/uploads/2015/05/INDICATE-LOGO-e1447365138298.png” bg_color=”” style=”margin: 0px 0px 0px 0px; padding: 45px 0px 45px 0px; “][x_row inner_container=”false” marginless_columns=”false” bg_color=”” style=”margin: 0px auto 0px auto; padding: 0px 0px 0px 0px; “][x_column bg_color=”” type=”1/1″ style=”padding: 0px 0px 0px 0px; “][x_gap size=”150px”][/x_column][/x_row][/x_section][x_section style=”margin: 0px 0px 0px 0px; padding: 0px 0px 0px 0px; “][x_row inner_container=”true” marginless_columns=”false” bg_color=”” style=”margin: 0px auto 0px auto; padding: 0px 0px 0px 0px; “][x_column bg_color=”#ffffff” type=”2/3″ class=”left-text ” style=”padding: 0px 0px 0px 0px; “][x_gap size=”20px”][x_custom_headline level=”h2″ looks_like=”h3″ accent=”false”]INDICATE[/x_custom_headline][x_text]Injection or Decompression in Carpal Tunnel Syndrome (INDICATE).[/x_text][x_alert type=”success” close=”false” heading=”INDICATE pilot complete”]The INDICATE protocol is published and pilot trial completed. The results are being prepared for publication. A definitive trial is not current feasible.[/x_alert][x_text]
UPDATE 14/11/2017: The final results were presented at the BSSH Autumn Scientific Meeting 2017. Click here for the presentation: Indicate BSSH presentation 2017.
UPDATE 03/09/2016: INDICATE-PILOT has completed recruitment. The results will be presented at the BSSH Autumn Scientific Meeting 2016.
The INDICATE Pilot Study (funded by the British Society for Surgery of the Hand, BSSH) is a pragmatic multicentre study to assess whether a steroid injection given initially is better than having surgery for patients with moderate carpal tunnel syndrome. The pilot will inform the design and conduct of a larger INDICATE study with regards to recruitment, data collection and outcome measurement. The Surgical Intervention Trials Unit (SITU) at the University of Oxford, will co-ordinate the trial. This study will form part of a developing research portfolio for the plastic and hand surgery community.[/x_text][x_custom_headline level=”h3″ looks_like=”h5″ accent=”false”]Background[/x_custom_headline][x_text]Carpal Tunnel Syndrome (CTS) is caused by compression of the median nerve in the wrist and presents with symptoms of tingling, numbness and pain in the hand, particularly at night. Patients usually state that the night symptoms are the most troublesome as the pain can be unremitting and sleep can be disturbed every night. CTS is the most common peripheral nerve disorder in the UK.
The treatment of CTS depends on its severity. Severe CTS is generally defined as presence of thenar muscle wasting and constant numbness indicating denervation. 87% of Clinical Commissioning Groups policies state that surgical decompression is warranted when these features are present.
Mild CTS should always be treated non-operatively while moderate CTS can be treated both non-operatively or with surgery. However there is no consensus as to the clinical distinction between mild and moderate CTS.
Steroid injections provide a good initial response in around 70-90% of patients with mild and moderate CTS but relapse is common. The duration of effect varies in the literature but one large recent study showed that 63% of patients had sustained effect after 6 months and this reduced to 34% after 18 months. There is no evidence to guide treatment following relapse of a first steroid injection though if the duration of effect was reasonable, some patients prefer to have further injections and avoid surgery. The natural history of CTS has not been well studied though there is some evidence that some patients with mild CTS improve both clinically and neurophysiologically without treatment.
Carpal tunnel decompression (CTD) surgery is usually performed as a day case under local anaesthesia. It is 90-95% effective in permanently relieving pain, paresthesia and intermittent numbness in CTS. However it incurs more risk and recovery time for the patient and expense to the healthcare system.
Across England, there is variability in Clinical Commissioning Groups’ (CCG) policies for funding referral for CTS, which leads to inconsistency in treatment. Both the variability in the CCGs’ policies and clinician’s approach to treatment stem from the paucity of good evidence on which to base treatment decisions. Therefore for patients with moderate CTS, the dilemma of whether to opt for surgery or steroid injection remains.[/x_text][x_custom_headline level=”h3″ looks_like=”h5″ accent=”false”]Objectives[/x_custom_headline][x_text]
- Assess ability to recruit to the trial
- Assess withdrawal rate
- Identify challenges and areas of concern in recruiting from the current patient pathway
- Collect patient feedback on the questionnaires/outcome measures
- Identify complications/Adverse Events
Patients will be recruited from primary and secondary care, depending on the patient pathway in their local area. Follow up data will be collected via postal questionnaires at 1, 3, 6, and 12 months randomisation.[/x_text][/x_column][x_column bg_color=”” type=”1/3″ style=”padding: 0px 0px 0px 0px; “][x_gap size=”20px”][x_accordion][x_accordion_item title=”Status” open=”true”][icon_list] [icon_list_item type=”check-square-o”]Protocol development [/icon_list_item] [icon_list_item type=”check-square-o”]NRES approval [/icon_list_item][icon_list_item type=”check-square-o”]Site set-up [/icon_list_item][icon_list_item type=”check-square-o”]Patient recruitment [/icon_list_item] [icon_list_item type=”check-square-o”]Data analysis[/icon_list_item] [icon_list_item type=”square”]Manuscript submission [/icon_list_item][icon_list_item type=”square-o”]Publication [/icon_list_item][/icon_list] [/x_accordion_item][x_accordion_item title=”Steering group” open=”false”]Will Mason
Chief Investigator
Gloucestershire Royal Hospital
Danny Ryan
Specialist Trainee Trauma & Orthopaedics
Severn Deanery
David Beard
Co-director
SITU, Oxford
Jonathan Cook
Associate Professor
Centre for Statistics in Medicine, Oxford
Cushla Cooper
Research Portfolio Manager
SITU, Oxford
Nicola Farrar
Clinical Trials Administrator
SITU, Oxford
Ines Rombach
Statistician
Oxford SITU
Julie Hapeshi
Deputy Director
South West Research Design Service
Hui-Ling Kerr
Specialist Trainee Trauma & Orthopaedics
Severn Deanery
Asif Khan
Specialist Trainee Trauma & Orthopaedics
Severn Deanery
Madeleine Dakin
Lay member and chairman of Patient Liaison group
Will Haynes
General Practitioner and Gloucestershire CCG Musculoskeletal Lead
Tim Holt
General Practitioner and NIHR Academic Clinical Lecturer, University of Oxford[/x_accordion_item][x_accordion_item title=”Collaborators” open=”false”]Will Mason
Chief Investigator
Gloucestershire Royal Hospital
Simon Richards
Principal Investigator
Royal Bournemouth Hospital
Jeremy Bland
Principal Investigator
Canterbury and East Kent Hospital
Caroline Clements
Principal Investigator
Orthopaedic Assessment Service in Somerset (OASIS) East
Carolyn Nation
Principal Investigator
Orthopaedic Assessment Service in Somerset (OASIS) West[/x_accordion_item][x_accordion_item title=”Trials Unit” open=”false”]Surgical Intervention Trials Unit (SITU)
University of Oxford[/x_accordion_item][x_accordion_item title=”Funding” open=”false”]BSSH research grant[/x_accordion_item][x_accordion_item title=”Downloads” open=”false”]
Indicate BSSH presentation 2017[/x_accordion_item][x_accordion_item title=”Contact” open=”true”]indicate@ndorms.ox.ac.uk[/x_accordion_item][/x_accordion][/x_column][/x_row][/x_section]