The SMOotH Study - Self Management in Osteoarthritis of the Hand: a randomised controlled trial in the community

ISRCTN	ISRCTN33870549
DOI	https://doi.org/10.1186/ISRCTN33870549
Protocol serial number	17958
Sponsor	Keele University (UK)
Funder	Arthritis Research Campaign (ARC) (UK) (grant ref: 17958)

Submission date: 26/11/2007
Registration date: 23/01/2008
Last edited: 01/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Krysia Dziedzic
Scientific

Primary Care Musculoskeletal Research Centre
Keele University
Newcastle-Under-Lyme
Staffordshire
ST5 5BG
United Kingdom

Phone	+44 (0)178 258 3907
Email	k.s.dziedzic@cphc.keele.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Self management, joint protection education and exercises in hand osteoarthritis: a randomised controlled trial in the community
Study acronym	SMOotH
Study objectives	Primary questions: 1. Is joint protection delivered by an Occupational Therapist (OT) more effective in reducing hand pain and disability than no joint protection in people with hand osteoarthritis (OA) in primary care? 2. Are hand exercises delivered by an OT more effective in reducing hand pain and disability than no hand exercises in people with hand OA in primary care? Secondary question: If joint protection and hand exercises are combined, is this more effective in reducing hand pain and disability than usual care in people with hand OA in primary care?
Ethics approval(s)	Ethics approval pending from the Central Manchester Research Ethics Committee (REC) as of 26/11/2007 (ref: 07/H1008/235). A favourable opinion was given by Central Manchester REC for our study on 22/02/2008.
Health condition(s) or problem(s) studied	Hand osteoarthritis
Intervention	Group 1 - usual care: Group 1 will receive information on general practice (GP) headed notepaper to continue with their own self-management approaches, which they will be asked to record in a diary, will receive standard advice on the use of analgesia and will be given the Arthritis Research Campaign (ARC) leaflet 'Looking after your joints'. Group 2 - usual care and joint protection principles: Participants will receive the same information and instructions as Group 1 above. In addition they will receive four group intervention classes held in a local OT department. The OT interventions will be held once a week for a maximum of 60 minutes and will involve 6 - 8 participants. Participants will be taught joint protection principles. Group 3 - usual care and hand exercises: Participants will receive the same information and instructions as Group 1 above. In addition they will receive four group intervention classes held in a local OT department. The OT interventions will be held once a week for a maximum of 60 minutes and will involve 6 - 8 participants. Participants will be taught hand exercises. Group 4 - usual care and joint protection principles and hand exercises: Participants will receive the same information and instructions as Group 1 above. In addition they will receive four group intervention classes held in a local OT department. The OT interventions will be held once a week for a maximum of 90 minutes and will involve 6 - 8 participants. Participants will be taught both joint protection principles and hand exercises. The OT group interventions (groups 2 - 4) will include a general introduction, education on hand OA and its management and management of pain during everyday activities. Educational-behavioural approaches will be adopted with goal-setting, pacing, problem-solving and challenging unhelpful beliefs. Participants will be encouraged to practice techniques taught in the classes, which will be reinforced by a participant manual. The joint protection approaches and hand exercises will be based on those previously used in rheumatoid arthritis with adaptation for hand OA. Outcomes for Groups 2 - 4 will be compared with outcomes for Group 1.
Intervention type	Other
Primary outcome measure(s)	The primary outcome will combine the pain and function subscales of the Australian/Canadian hand osteoarthritis measure (AUSCAN) with a global assessment of improvement (6 point scale: completely better, much better, better, same, worse, much worse) according to the Osteoarthritis Research Society International (OARSI)/Outcome Measures in Rheumatology (OMERACT) criteria to determine whether each individual is a 'responder' to treatment. Outcome measures will be completed at baseline, 3, 6 and 12 months. The primary end point will be 6 months.
Key secondary outcome measure(s)	1. Global assessment of change of hand problem at 3, 6 and 12 months 2. Individual subscales of the AUSCAN (Pain, stiffness and function) at recruitment, baseline, 3, 6 and 12 months 3. Hand pain manikin at recruitment, 3, 6 and 12 months. Participants are asked if they have had any ache or pain that has lasted for one day or longer in their hands. Individuals responding positively to this question are then asked to shade in a diagram of the hands (backs and palms) indicating where this ache or pain has been experienced. 4. Average pain severity over the past 3 days, assessed at baseline, 6-month clinic assessment and at 12 months 5. Severity rating of participant nominated main functional problem over the past 3 days, assessed at baseline and 6-month clinic assessment, 3 and 12 months 6. Frustration related to hand disability, assessed at baseline, 3, 6 and 12 months 7. Participation restriction, assessed at recruitment, 3, 6 and 12 months 8. Quality of life: 8.1. EuroQol EQ-5D instrument at baseline, 3, 6 and 12 months 8.2. 12-item short form version 2 (SF-12v2) questionnaire at recruitment, 3, 6 and 12 months 9. Generic measure of disability, assessed by SF-12v2 at recruitment, 3, 6 and 12 months 10. Self-efficacy in relation to pain (Arthritis Self-Efficacy pain subscale), assessed at baseline, 3, 6 and 12 months 11. Illness perceptions, measured by Illness Perceptions Questionnaire Revised (IPQ-R) modified for hand OA, assessed at recruitment, baseline, 3, 6 and 12 months 12. Side-effects of treatment and adverse events 13. Co-interventions: 13.1. From consultation download: follow-up visits to the GP, prescription of medication including non-steroidal anti-inflammatory drugs (NSAIDs), referral for other treatment such as surgery 13.2. From self-reported questionnaires: self-help remedies, contacts with private health care, over the counter medicines, use of hand splints 14. Satisfaction with care, assessed at 3 and 6 months 15. Self-reported behaviour change, assessed at baseline, 3, 6 and 12 months
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	252
Key inclusion criteria	1. Males and females aged 50 years and over 2. Fulfilling the American College of Rheumatology (ACR) definition of symptomatic hand OA, or symptomatic thumb base OA on clinical assessment 3. No other household member participating in the trial 4. Ability to understand and capable of giving written informed consent 5. Available to attend OT classes if allocated to receive OT intervention 6. Able to give informed consent
Key exclusion criteria	1. Consultation or treatment for this hand problem in the previous 6 months including: 1.1. Intra-articular joint injection to wrist, fingers or thumb 1.2. Fractures or significant injury or surgery to the wrist or hand 1.3. Consultation for this hand problem with an OT or physiotherapist 2. Red flags e.g., history of serious illness or disease (e.g., rheumatoid arthritis, psoriatic arthritis, stroke), progressive neurological signs, acute swollen joint 3. Minimal pain and function on the primary outcome measures (Australian/Canadian hand outcome score [AUSCAN] pain less than 5, function less than 9)
Date of first enrolment	01/06/2007
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Keele University

Staffordshire
ST5 5BG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2015		Yes	No
Protocol article	protocol	11/07/2011		Yes	No
Other publications	economic evaluation	01/05/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes