Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077135302
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
02/02/2004
Overall trial end date
31/07/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
70
Participant 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.
Recruitment start date
02/02/2004
Recruitment end date
31/07/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Southern Derbyshire Acute Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary