Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Barbara Bown


Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Derbyshire Royal Infirmary
London Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet


Musculoskeletal Diseases: Osteoarthritis of the thumb


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



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


Overall trial end date


Reason abandoned


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


Age group

Not Specified


Not Specified

Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
United Kingdom

Sponsor information


Department of Health

Sponsor details

Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes