Osteoarthritis thumb therapy trial II
| ISRCTN | ISRCTN54744256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54744256 |
| Secondary identifying numbers | 31053 |
- Submission date
- 26/09/2016
- Registration date
- 26/09/2016
- Last edited
- 01/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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 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 March 2019
Who is funding the study?
Arthritis Research UK (UK)
Who is the main contact?
Dr Joanna Adams
ja@soton.ac.uk
Contact information
Scientific
School of Health Sciences
University of Southampton
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
 ORCID ID |
0000-0003-1765-7060 |
|---|---|
| Phone | +44 (0)2380 595287 |
| ja@soton.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Education or Self-Management, Rehabilitation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Osteoarthritis Thumb Therapy trial: a randomised controlled trial into the effectiveness and efficacy of splints in thumb base osteoarthritis |
| Study 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(s) | South Central - Oxford C Research Ethics Committee, 04/05/2016, ref: 16/SC/0188 |
| 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 |
| Primary outcome measure | Hand pain is measured uisng the AUSCAN index for hand pain at baseline, 8 and 12 weeks Updated 01/03/2019 to remove the 4-week questionnaire. |
| 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, 8 and 12 weeks 2. Satisfaction with hand function over the past week is measured using an ordinal rating scale at baseline, 8 and 12 weeks 3. Hand pain severity over the last week is measured using an ordinal rating scale at baseline, 8 and 12 weeks 4. Thumb pain over the last week is measured using an ordinal rating scale at baseline, 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, 8 and 12 weeks 6. Generic Quality of Life is measured using the SF12v2 at baseline, 8 and 12 weeks 7. General health is measured using the EuroQol 5 Dimensions 5-Levels questionnaire at baseline, 8 and 12 weeks 8. Self-efficacy is measured using the Arthritis Self-efficacy pain subscale at baseline, 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, 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 Updated 18/02/2019 to remove the 4-week questionnaire. |
| Overall study start date | 01/03/2016 |
| Overall study end date | 31/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 345; UK Sample Size: 345 |
| Total final enrolment | 349 |
| 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 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 | 28/02/2017 |
| Recruitment end date | 11/12/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Poole
BH15 2JB
United Kingdom
Sponsor information
Hospital/treatment centre
University Road
Highfield
Southampton
SO17 1BJ
England
United Kingdom
"ROR" |
https://ror.org/01ryk1543 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | As of 14/09/2020, the manuscript detailing the study results has been submitted for publication and is currently undergoing peer review. We will update this webpage with results as soon as the results have been published. |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/10/2019 | 14/09/2020 | Yes | No |
| Results article | results | 30/11/2020 | 01/12/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/12/2020: Publication reference and total final enrolment number added.
14/09/2020: The following changes have been made:
1. Publication reference added.
2. The publication and dissemination plan has been updated from the previous text of "Planned publication in a peer reviewed journal.".
3. The intention to publish date has been changed from 31/08/2020 to 31/12/2020.
26/07/2019: The following changes were made:
1. The overall trial end date was updated from 31/07/2019 to 31/08/2019.
2. The intention to publish date was updated from 31/07/2020 to 31/08/2020.
01/03/2019: The following changes were made to the trial record:
1. The primary outcome measures were updated.
2. The recruitment start date was changed from 31/10/2016 to 28/02/2017.
18/02/2019: The secondary outcome measures were updated.
08/01/2019: The recruitment end has been updated from 20/12/2018 to 11/12/2018.
23/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2018 to 20/12/2018.
2. The overall trial end date was changed from 31/03/2019 to 31/07/2019.
3. The intention to publish date was changed from 31/03/2020 to 31/07/2020.
23/07/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/05/2018 to 31/08/2018.
2. The overall trial end date was changed from 30/11/2018 to 31/03/2019.
3. The intention to publish date was changed from 01/11/2019 to 31/03/2020.
30/09/2016: Verified study information with principal investigator.
