Condition category
Musculoskeletal Diseases
Date applied
26/09/2016
Date assigned
26/09/2016
Last edited
30/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Osteoarthritis (OA) is the most common type of arthritis, affecting millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, which can cause stiffness, pain and a reduction in a person’s range of movement. Osteoarthritis in the joint at the base of the thumb (symptomatic thumb base OA) affects about 20% of people over 55 years of age, and causes more pain, work disability, reduced quality of life and function than OA elsewhere in the hand. International experts recommend splinting (using a rigid strip of material to support the joints and restrict movement) for hand OA but there is limited evidence from robust studies to support this. The aim of this study is to investigate the effectiveness of splinting in people with thumb base OA.

Who can participate?
Patients aged 30 and over with thumb base OA

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group take part in a self-management package, which involves being given information and learning exercises to help reduce pain and improve function in the hand to complete at home. Participants in the second group also take part in the self-management package but are also given a thumb splint to wear, which restricts movement, for at least six hours every day. Participants in the third group take part in the self-management package and are given a thumb splint to wear which is less restrictive of movement, for at least six hours every day. At the start of the study and then again after 4, 8 and 12 weeks, participants complete a number of questionnaires to assess their hand pain and function.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk that participants in the thumb splint groups may find wearing the splint uncomfortable.

Where is the study run from?
Poole Hospital (UK)

When is the study starting and how long is it expected to run for?
March 2016 to November 2018

Who is funding the study?
Arthritis Research UK (UK)

Who is the main contact?
Dr Joanna Adams
ja@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Joanna Adams

ORCID ID

http://orcid.org/0000-0003-1765-7060

Contact details

School of Health Sciences
University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
+44 2380 595287
ja@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31053

Study information

Scientific title

Osteoarthritis Thumb Therapy trial: A randomised controlled trial into the effectiveness and efficacy of splints in thumb base osteoarthritis

Acronym

OTTER II

Study hypothesis

The aim of this study is to evaluate whether there is any benefit of adding a thumb base splint to a self-management intervention for people with thumb base osteoarthritis (OA).

Ethics approval

South Central - Oxford C Research Ethics Committee, 04/05/2016, ref: 16/SC/0188

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Musculoskeletal disorders, Primary sub-specialty: Elective orthopaedic surgery; UKCRC code/ Disease: Musculoskeletal/ Arthrosis

Intervention

Participants are randomised to one of three groups.

Group 1: Participants undertake the self-management package alone for eight weeks. The self management package includes being given booklets containing hand exercises, information about how to protect hand joints and general information about osteoarthritis (booklet produced by Arthritis Research UK). In addition, participants receive a personal exercise guide which is used to facilitate consideration of barriers and enablers to completing the exercises and an exercise diary to record when the exercises are completed.

Group 2: Participants undertake the self-management package plus thumb splint (Procool Thumb Restriction Splint or Orfilight Thermoplastic Trouser Splint) to wear for a minumum of six hours per day for eight weeks; a personal splint wearing guide which is used to facilitate consideration of barriers and enablers to wearing the splint; a splint wear diary to record how much the splint is worn; and a splint wear hours guide which explains when to wear the splint.

Group 3: Participants undertake the self-management package plus thumb splint (DM Orthotics Thumb Sleeve or DM Orthotics Thumb Sleeve Lite) to wear for a minumum of six hours per day for eight weeks; a personal splint wearing guide which is used to facilitate consideration of barriers and enablers to wearing the splint; a splint wear diary to record how much the splint is worn; and a splint wear hours guide which explains when to wear the splint.

Participants in all groups are followed up at 4, 8 and 12 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Hand pain is measured uisng the AUSCAN index for hand pain at baseline, 4, 8 and 12 weeks.

Secondary outcome measures

1. Overall response to treatment is measured using the OMERACT responder criteria that combines:
1.1. Global assessment of change for thumb base problem rating from “completely recovered” to “very much worse” on a 5 point ordinal rating scale
1.2. AUSCAN hand function index
1.3. AUSCAN hand pain index
at baseline, 4, 8 and 12 weeks
2. Satisfaction with hand function over the past week is measured using an ordinal rating scale at baseline 4, 8 and 12 weeks
3. Hand pain severity over the last week is measured using an ordinal rating scale at baseline 4, 8 and 12 weeks
4. Thumb pain over the last week is measured using an ordinal rating scale at baseline 4, 8 and 12 weeks
5. Ability to take part in leisure activities is measured using The Disability of the Arm, Shoulder and Hand Questionnaire (leisure section only, 3 ordinal questions) at baseline 4, 8 and 12 weeks
6. Generic Quality of Life is measured using the SF12v2 at baseline 4, 8 and 12 weeks
7. General health is measured using the EuroQol 5 Dimensions 5-Levels questionnaire at baseline 4, 8 and 12 weeks
8. Self-efficacy is measured using the Arthritis Self-efficacy pain subscale at baseline 4, 8 and 12 weeks
9. Hand function is measured using the clinician assessed Grip Ability Test at baseline, 4 and 8 weeks
10. Health care resource use and associated costs are measured at 8 and 12 weeks. Costs included will be: provision of intervention splints, hospitalisation and associated length of stay, outpatient and A&E visits and primary care visits (both in practice and at home from general practitioners, nurses and community therapists). Resource use will be valued using readily available NHS Reference costs, UK costs of health and social care and the list prices in the British National Formulary.
11. Work and activity is measured using the Work Productivity and Activity Impairment Questionnaire (WPAI) at baseline 4, 8 and 12 weeks
12. Perceived splint effectiveness, preference and adherence for a purposive sample of splint group participants (n=40) is measured using a detailed qualitative exit telephone interview placed between 8 week appointment and 12 week follow up questionnaire

Overall trial start date

01/03/2016

Overall trial end date

30/11/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females aged 30 years and over
2. At least moderate AUSCAN hand pain (AUSCAN Hand pain score >5) and functional hand disability
(AUSCAN hand functional disability score >9)
3. One of the following:
3.1. Hard tissue enlargement of the first carpometacarpal joint (CMCJ)
3.2. Squaring of the thumb base
3.3. Pain that worsens when pinching
3.4 Pain that worsens on span grip (eg opening a jar)
3.5. Crepitus on movement
3.6. Reduction in thumb base range of movement
3.7. Positive thumb adduction provocation test
3.8. Positive thumb extension provocation test
3.9. Pain on palpation of the dorso-radial aspect of the thumb CMCJ
4. No other household member participating in the trial
5. Able to give written informed consent
6. Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 345; UK Sample Size: 345

Participant exclusion criteria

1. Consultation with therapy department or treatment for this thumb problem (excluding pain killers and anti-inflammatories) in the previous 6 months
2. Intra-articular joint injection to wrist, fingers or thumb in the previous 2 months
3. Fractures or significant injury or surgery to the wrist or hand within the previous 6 months
4. Red flags e.g. history of serious illness or disease (e.g. rheumatoid arthritis, psoriatic arthritis), progressive neurological signs, acute swollen joint
5. Diagnosis of dementia or significant disorder likely to affect communication
6. Already received thumb splints for thumb base OA
7. Skin disease that may interfere or contraindicate splint wear
8. Participants of a drug or medical device trial in the last 12 weeks

Recruitment start date

31/10/2016

Recruitment end date

01/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

University Road
Highfield
Southampton
SO17 1BJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Arthritis Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD Sharing plan:
Requests for access to data will be considered by the Chief Investigator and the TSC. Requests will be considered in accordance with the University of Southampton’s recommended practices for permitting access to research data and the Chief Investigator will make the final decision.

Intention to publish date

01/11/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/09/2016: Verified study information with principal investigator.