A comparison of general and specific dynamic stability exercises in osteoarthritis of the carpometacarpal joint of the thumb.

ISRCTN	ISRCTN28238521
DOI	https://doi.org/10.1186/ISRCTN28238521
Secondary identifying numbers	N0077135302

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 19/02/2014

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Barbara Bown
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	The hypothesis to be tested is that specific exercises to strengthen a stabilising muscle of the thumb (Abductor Pollicis Longus [APL]) will reduce pain at rest and during pinch grip, improve pinch strength and improve function more than a general exercise group.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Musculoskeletal Diseases: Osteoarthritis of the thumb
Intervention	Subjects will be given information about the study and their consent obtained by staff in the research department. Baseline assessments will then be completed by the researcher. These will consist of measures of pain (Visual analogue scale), function (Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire), pinch strength (pinch gauge), pain during pinch, Abductor Pollicis Longus (APL) strength (measured by a load cell) and demographic data. The sample size required has been determined by a power calculation. As there are no previous papers investigating similar physiotherapy interventions for OA in this joint the power calculation is based on the researcher's own clinical experience. Based on clinical observations it has been assumed that general exercise will improve patient's symptoms by 20% and the specific regime will improve patients by 50%. To demonstrate a 50% change in the outcome measures it has been calculated that a sample size of 54 subjects is required with a set at 0.05 and a power of 90%. A pilot study will be performed prior to the study, therefore a total of 70 subjects will be recruited. Subjects will be randomly assigned to either the specific exercise or general exercise programme by the use of the sealed envelope method. This process will be blinded and performed by research department staff in order to eliminate any potential researcher bias. Subjects will be identified by a number and the researcher will have no access to the data regarding randomisation until the end of the trial. Subjects will not be told which exercise regime they have been assigned to. All subjects will be treated by the same physiotherapist to improve reliability. All patients will have an initial appointment where they are given the same standardised written and verbal advice. They will then go on to receive different regimes of exercise depending on the group they have been assigned to. All subjects will then be seen by the same physiotherapist at two, four and eight weeks. Exercises will be progressed according to the protocol for that group. The initial measures will then be repeated by the researcher at twelve weeks and six months post commencement of exercise. The researcher will be blinded to the treatment group. The data will be analysed using a Statistical Package for Social Scientists (SPSS) statistical computer package.
Intervention type	Other
Primary outcome measure	DASH (disability of arm, shoulder and hand) functional outcome questionnaire. Pain will be measured using a visual analogue scale at rest and during a pinch grip. Pinch strength will be measured using a pinch gauge. APL (Abductor Pollicis Longus) strength will be measured using a specially designed load cell.
Secondary outcome measures	Not provided at time of registration
Overall study start date	02/02/2004
Completion date	31/07/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	70
Key inclusion criteria	All patients attending hand clinic with osteoarthritis (OA) of the carpometacarpal joint of the thumb will be seen by a specialist hand consultant in a designated clinic and all patients will be considered for inclusion in the study. Patients referred to occupational therapy via their GP will also be considered for inclusion. Their diagnosis will be a clinical diagnosis confirmed radiographically and subjects will then have the severity of their OA graded using the Eaton and Littler system.
Key exclusion criteria	Subjects will be excluded if they have suspected or confirmed inflammatory joint disease, coexisting hand conditions in the affected hand or are unable to cooperate with exercise regime.
Date of first enrolment	02/02/2004
Date of final enrolment	31/07/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE1 2QY
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Southern Derbyshire Acute Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan