Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000600145
Ethics application status
Approved
Date submitted
11/03/2019
Date registered
17/04/2019
Date last updated
12/11/2021
Date data sharing statement initially provided
17/04/2019
Date results information initially provided
12/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of resisted exercise on pain and function in people with de Quervain's syndrome
Scientific title
The clinical effectiveness of isometric exercise for the management of de Quervain’s syndrome: A pilot randomised controlled feasibility trial
Secondary ID [1] 296897 0
Nil known
Universal Trial Number (UTN)
U1111-1226-7735
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
de Quervain's syndrome 310847 0
Condition category
Condition code
Musculoskeletal 309523 309523 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once eligible, all participants will receive a custom-made thermoplastic wrist and thumb orthosis, which will be worn for a period of 2 weeks. Participants will be instructed to wear the orthosis as much as possible including overnight, excluding hygiene activities. They will also receive condition specific education and be instructed in range of motion exercises. Education will be provided in the form of verbal information delivered by their treating clinician and standardized written information that the participant will take home. This education will be reinforced during all clinical contact as required (up to 7 sessions), with the opportunity for participants to ask questions. Range of motion exercises will be active wrist and thumb movements , with specific movements selected at the treating clinician’s discretion. These may include ulnar and radial deviation of the wrist, wrist flexion and extension, thumb flexion, extension, abduction, or circumduction. Participants will be instructed to complete these with no more than mild discomfort experienced during the movement. Participants will record their orthosis wear and exercises in a diary.

Prior to receiving any intervention, particiapntsparticipants will be asked to rate their expectation of change with exercise, education and orthosis using a categorical scale of 'Completely recover', 'much improve', 'slightly improve', 'no change' and 'worse'.

After 2 weeks, participants will be reassessed. Those no longer meeting the criteria for probable or likely de Quervain’s syndrome based on the de Quervain’s Screening Tool (DQST), will be instructed in graded weaning from the orthosis, and will not be randomised or included in statistical analysis in this trial as they will receive no further intervention as part of this study. We will follow these participants up at 4 and 12 weeks post exclusion from the intervention.
Those still meeting the criteria for probable or ‘likely’ de Quervain’s syndrome according to the DQST will be randomised into the 2 intervention arms. Stratified block randomisation with be performed based on whether participants are within a 12 month postpartum period.


Arm 1: Low load isometric exercise
Participants will be instructed in the performance of low load (25% of 1 repetition maximum) isometric thumb extension. This will be performed using a purpose-built device incorporating a spring gauge. Using the contralateral hand, participants will set the spring gauge to the prescribed load. Participants will then place their affected thumb under the load of the spring gauge and instructed to keep their thumb still whilst maintaining the spring gauge at the prescribed level. Participants will perform this exercise at home daily, with a dosage of 20 second holds, 5 repetitions, with 1 minute rest between each repetition. Participants will be reviewed weekly for 4 weeks by the treating clinician, in an individual session, in an outpatient clinic setting. Should the participant report increasing pain with exercise performance, the duration of the hold will be reduced and the number of repetitions increased. Should the participant not tolerate the adjusted exercise following 1 day, they will be advised to cease the load exercise and resume wearing the orthosis as much as possible for 1 week, at which time the exercise regime will be introduced. Should the participant not tolerate the load exercise in 3 consecutive weeks, intervention will be delivered at the discretion of their treating clinician, or clinician of their choice.
Throughout the intervention period, participants will be instructed in pain-free range of motion exercises of the wrist and thumb, and graded weaning from the orthosis. At the conclusion of the intervention period (4 weeks of exercise), participants will be advised to continue treatment at the discretion of their treating clinician, or clinician of their choice.
The study intervention will be delivered by a Physiotherapist or Occupational therapist with at least 5 years experience working with people with wrist injuries.
Intervention code [1] 313172 0
Rehabilitation
Comparator / control treatment
Arm 2: Higher load isometric group
Participants will be instructed in the performance of high load (70% of 1 repetition maximum) isometric thumb extension. This will be of the same duration and repetition dosage as the low load isometric arm. All other intervention (education, orthosis, range of motion exercises) will be the same for both groups.
Control group
Active

Outcomes
Primary outcome [1] 308472 0
Feasibility
Feasibility will be measured using rate of recruitment, number of drop-outs, and adherence to all aspects of the intervention. Qualitative data will include participant satisfaction with treatment, and participant and clinician experiences of all the study procedures. These will be assessed via qualitative interview via a series of standardised questions related to participants' and clinicians' experience of the study processes, the programs.
Adherence will be recorded through attendance to sessions and a participant-completed diary.
Timepoint [1] 308472 0
Adherence: weekly for weeks 0-6, and at 14 weeks
Clinician's experiences of the study: At study conclusion
Other measures of feasibility: 14 weeks
Primary outcome [2] 319303 0
Safety
Safety will be assessed using reported adverse events, such as persisting increased discomfort that participants report is related to exercise.
Timepoint [2] 319303 0
Adverse events: Weeks 2, 3, 4, 5, 6, 14
Secondary outcome [1] 355091 0
Participant’s perception of improvement: assessed using a 11-point global rating of change scale.
Timepoint [1] 355091 0
2 weeks, 6 weeks and 14 weeks post commencement of intervention
Secondary outcome [2] 355092 0
QuickDASH (qDASH): an 11-item participant reported questionnaire, where a lower score is indicative of greater function.
Timepoint [2] 355092 0
Baseline, 2 weeks (at randomisation, primary start point), 6 weeks (conclusion of isometric exercise period) and 14 weeks (12 weeks after primary start point) after commencement of intervention.
Secondary outcome [3] 355093 0
Pain and Function using the Patient Rated Wrist and Hand Evaluation: a participant reported questionnaire addressing pain and function, using visual analogue scales. Equal weighting is given to pain and function for an overall score, where a higher score indicates greater pain and functional deficits. The subscales included in the pain category include pain at rest, during a repetitive task, lifting a heavy object and at its worst.
Timepoint [3] 355093 0
Baseline, 2 weeks, 6 weeks and 14 weeks post commencement of intervention.
Secondary outcome [4] 355095 0
Maximal grip strength measured using digital dynomometry. Grip strength will be measured using a hand held dynamometer. Participants will perform 3 trials.
Timepoint [4] 355095 0
Baseline, 2 weeks, 6 weeks and 14 weeks post commencement of intervention
Secondary outcome [5] 355096 0
Active range of motion: wrist ulnar deviation measured using goniometry.

Timepoint [5] 355096 0
Baseline, 2 weeks, 6 weeks and 14 weeks post commencement of intervention
Secondary outcome [6] 355097 0
Other treatments received (Participant and clinician report)
Timepoint [6] 355097 0
2 weeks, 6 weeks and 14 weeks post commencement of intervention
Secondary outcome [7] 367128 0
Response to single dose of exercise: Change between pre- and post-exercise active range of ulnar deviation measured using goniometry If participants demonstrate full range of motion without pain, they will be asked to perform ulnar deviation with their thumb adducted to the side of their palm. If participants again demonstrate full range of motion without pain, they will be asked to perform ulnar deviation with their thumb tucked into their palm and fingers loosely holding their thumb in position.
Timepoint [7] 367128 0
Week 2 (at randomisation)
Secondary outcome [8] 369516 0
Maximum pinch strength measured using a digital pinch gauge. Participants will perform 3 trials.
Timepoint [8] 369516 0
Baseline, 2 weeks, 6 weeks and 14 weeks post commencement of intervention
Secondary outcome [9] 369517 0
Pain with active range of wrist ulnar deviation. This will be measured using a numerical rating scale
Timepoint [9] 369517 0
Baseline, 2 weeks, 6 weeks, 14 weeks post commencement of intervention
Secondary outcome [10] 369518 0
Active range of motion: thumb extension measured using goniometry
Timepoint [10] 369518 0
Baseline, 2 weeks, 6 weeks, 14 weeks post commencement of intervention
Secondary outcome [11] 369519 0
Pain with active thumb extension. This will be measured using a numerical rating scale
Timepoint [11] 369519 0
Baseline, 2 weeks, 6 weeks, 14 weeks post commencement of intervention
Secondary outcome [12] 369520 0
Active range of motion: thumb flexion, measured using the Kapandji score
Timepoint [12] 369520 0
Baseline, 2 weeks, 6 weeks, 14 weeks post commencement of intervention
Secondary outcome [13] 369521 0
Response to single dose of exercise: Change between pain rating during ulnar deviation pre- and post-exercise performance
Timepoint [13] 369521 0
Week 2 (at randomisation)
Secondary outcome [14] 369523 0
Response to single dose of exercise: Change between pain (numerical rating scale). Participant will rate their pain using a numerical rating score during personal care activities in the morning of exercise (pre-exercise), at the start of the exercise session, immediately following exercise, and with personal care activities the following morning.
Timepoint [14] 369523 0
Week 2 (morning of initiation of exercise, at the start of the first isometric exercise session, immediately after first isometric exercise completion, and the day after initiation of isometric exercise)
Secondary outcome [15] 369524 0
Response to single dose of exercise: Change between stiffness (numerical rating scale). Participant will rate their pain using a numerical rating score during personal care activities in the morning of exercise (pre-exercise), at the start of the exercise session, immediately following exercise, and with personal care activities the following morning.
Timepoint [15] 369524 0
Week 2 (morning of initiation of exercise, at the start of the first isometric exercise session, immediately after first isometric exercise completion, and the day after initiation of isometric exercise)
Secondary outcome [16] 370699 0
Pain with active thumb flexion. This will be measured using a numerical rating scale
Timepoint [16] 370699 0
Baseline, 2 weeks, 6 weeks, 14 weeks

Eligibility
Key inclusion criteria
Participants will be elligble for inclusion if they:
- are aged 18 years or over,
- meet the diagnostic criteria of “probable” or “almost certain” de Quervain’s syndrome on the de Quervain’s Screening Tool (DQST).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include:
- systemic inflammatory conditions,
- complex regional pain syndrome (CRPS),
- any concomitant fractures, ligamentous injuries or conditions of the affected upper limb, impacting their ability to participate in either treatment protocol or outcome measure assessment,
- previous surgery impacting the 1st extensor compartment of the wrist, for example a de Quervain’s release or radial plate fixation for distal radial fracture management,
- corticosteroid injection in the radial wrist region within 3 months of enrolment into the study;
- Previous treatments (orthosis or exercise) similar to those in this study lasting greater than 2 weeks for the management of de Quervain's syndrome, during this episode of pain
- injury management funded by a compensable body
-pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in unmarked, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a random sequence number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Stratified block randomisation with be performed. Participants will be stratified based on whether they are within a 12 month postpartum period or not.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Primary outcomes of recruitment rate, adverse events, adherence and drop-outs will be reported using descriptive statistics.
Data will be analysed on intention to treat principles. Data analysed will address between group treatment and within group treatment effects at each outcome time point. Multiple imputation will be used for missing data using five iterations, with sex, post-partum status, baseline scores, and group allocation as predictors.
The secondary outcome of qDASH at 6 weeks will be analysed using a two-way analysis of covariance (ANCOVA), including the baseline score as a covariate. Participant characteristics of post-partum status, sex, duration of symptoms, and expectation of improvement will be used as covariates.
The calculated sample size required based on the secondary outcome of the qDASH is 26 participants in each group to detect a minimal clinically important difference of 14 points, assuming a standard deviation of 20 (Alpha 0.05 and power of 0.80) (Sorensen et al, 2013). To account for potential drop-outs, we will aim to recruit a total of 60 participants, 30 per group.

Other continuously scored secondary outcome measures will be analysed using analysis of covariance with intervention group and baseline scores as covariates. Participant perception of improvement scores will be compared using relative risk, risk difference, and number needed to treat.
Descriptive statistics will be utilise to describe demographic characteristics, expectation of improvement, and treatments received during the follow-up period.



Sorensen, A. A., Howard, D., Tan, W. H., Ketchersid, J., & Calfee, R. P. (2013). Minimal clinically important differences of 3 patient-rated outcomes instruments. The Journal of hand surgery, 38(4), 641-649

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
COVID related restrictions
Date of first participant enrolment
Anticipated
31/05/2019
Actual
5/06/2019
Date of last participant enrolment
Anticipated
31/05/2021
Actual
30/04/2021
Date of last data collection
Anticipated
31/07/2021
Actual
Sample size
Target
60
Accrual to date
Final
29
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25203 0
3083 - Bundoora
Recruitment postcode(s) [2] 25204 0
3000 - Melbourne
Recruitment postcode(s) [3] 25205 0
3041 - Essendon North
Recruitment postcode(s) [4] 25206 0
3004 - Melbourne
Recruitment postcode(s) [5] 33285 0
3065 - Fitzroy
Recruitment postcode(s) [6] 33286 0
3155 - Boronia
Recruitment postcode(s) [7] 33287 0
3029 - Hoppers Crossing

Funding & Sponsors
Funding source category [1] 301468 0
Charities/Societies/Foundations
Name [1] 301468 0
Australian Hand Therapy Association
Country [1] 301468 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University,
Bundoora, VIC 3083
Country
Australia
Secondary sponsor category [1] 301161 0
None
Name [1] 301161 0
Address [1] 301161 0
Country [1] 301161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302208 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 302208 0
La Trobe University,
Bundoora, VIC 3083
Ethics committee country [1] 302208 0
Australia
Date submitted for ethics approval [1] 302208 0
Approval date [1] 302208 0
02/11/2018
Ethics approval number [1] 302208 0
HEC18429

Summary
Brief summary
The purpose of this study is to investigate the feasibility and safety of a randomised controlled trial (RCT) to examine the effectiveness of isometric exercises in the management of de Quervain's syndrome, and compare low load to high load exercises. All participants will receive a thermoplastic orthosis and education regarding the condition. Participants will then be randomised into low load (25% of max) or high load (70% of max) thumb extension exercises.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89466 0
Ms Brodwen McBain
Address 89466 0
La Trobe Sport and Exercise Medicine Research Centre
College of Science, Health and Engineering
La Trobe University
Bundoora
Victoria 3086
Country 89466 0
Australia
Phone 89466 0
+61 394796498
Fax 89466 0
Email 89466 0
[email protected]
Contact person for public queries
Name 89467 0
Ms Brodwen McBain
Address 89467 0
La Trobe Sport and Exercise Medicine Research Centre
College of Science, Health and Engineering
La Trobe University
Bundoora
Victoria 3086
Country 89467 0
Australia
Phone 89467 0
+61 394796498
Fax 89467 0
Email 89467 0
[email protected]
Contact person for scientific queries
Name 89468 0
Ms Brodwen McBain
Address 89468 0
La Trobe Sport and Exercise Medicine Research Centre
College of Science, Health and Engineering
La Trobe University
Bundoora
Victoria 3086
Country 89468 0
Australia
Phone 89468 0
+61 394796498
Fax 89468 0
Email 89468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIsometric thumb extension exercise as part of a multimodal intervention for de Quervain's syndrome: A randomised feasibility trial.2023https://dx.doi.org/10.1177/17589983231158499
N.B. These documents automatically identified may not have been verified by the study sponsor.