Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001136594
Ethics application status
Approved
Date submitted
11/10/2015
Date registered
27/10/2015
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results information initially provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain and isometric Exercise for Tennis Elbow
Scientific title
Investigation of the effects of 8 weeks of isometric exercise on pain, disability and endogenous analgesia, compared to control (advice and activity modification) for unilateral tennis elbow.
Secondary ID [1] 287635 0
none
Universal Trial Number (UTN)
U1111-1175-410
Trial acronym
PETE2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tennis elbow (lateral epicondylalgia) 296458 0
Condition category
Condition code
Musculoskeletal 296716 296716 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the exercise group will complete a daily home program of isometric exercise for 8 weeks. Following baseline examination, participants allocated to exercise will receive a 30 minute individualised session with the trial Physiotherapist who will provide written and verbal education about the exercise program as well as general advice regarding activity modification. Participants will be provided equipment (flask with handle) to begin their home program the following day. Isometric exercise will be performed by holding the water filled container in the affected arm, with the forearm resting on the edge of a table (elbow approximately 90 degrees flexion, forearm pronated, wrist 30 degrees extension). The water level will be initially filled to achieve a load equivalent to 20% of the maximal voluntary wrist extension capacity of the unaffected arm. Participants will be instructed to increase the load by 5% each fortnight (by adding a set volume of water). The following progressions will be adopted to enable a progressive increase in weekly exercise volume (load x hold time x sets).
Week 1: 20% load, 4x30s isometric holds, 30s intervals
Week 2: 20% load, 3x45s isometric holds, 30s intervals
Week 3: 25% load, 4x30s isometric holds, 30s intervals
Week 4: 25% load, 3x45s isometric holds, 30s intervals
Week 5: 30% load, 4x30s isometric holds, 30s intervals
Week 6: 30% load, 3x45s isometric holds, 30s intervals
Week 7: 35% load, 4x30s isometric holds, 30s intervals
Week 8: 35% load, 3x45s isometric holds, 30s intervals
Participants will complete a daily exercise diary to evaluate compliance (load, duration and sets achieved) and symptoms (rating of perceived exertion (RPE-CR10 and pain intensity (numercial rating scale, 0=no pain, 10=worst imaginable pain) during exercise. Exercise diaries will be sent to the trial Physiotherapist at the end of each week.
Intervention code [1] 293036 0
Rehabilitation
Comparator / control treatment
Participants assigned to the control group will receive a booklet outlining standardised care (e.g., advice to remain active and continue activities that do not provoke their pain; to avoid activities that sharply increase their elbow pain or last longer than 10 minutes; to avoid gripping or lifting with the forearm pronated and arm outstretched; use over the counter pain medication or ice packs as needed). Following baseline examination, participants will meet with the trial Physiotherapist for a 15 minute individualised session to discuss the advice contained in the brochure.
Control group
Active

Outcomes
Primary outcome [1] 296332 0
Global rating of change (6 point Likert scale with categories: Completely recovered, much improved, improved, same, worse, much worse)
Timepoint [1] 296332 0
8 weeks
Primary outcome [2] 296337 0
Patient rated tennis elbow evaluation (PRTEE) - 15 questions concerning pain and disability, equally summed to give a total score.
Timepoint [2] 296337 0
0, 8 weeks
Primary outcome [3] 296338 0
Pain free grip force (N) will be measured over the affected arm with participant supine, arm pronated and resting on the bed. The participant will grip an electronic hand held dynamometer, stopping when they first experience pain. Maximal grip force will be measured over the unaffected arm in the same position. An average of three repetitions will be used in analysis.
Timepoint [3] 296338 0
0, 8 weeks
Secondary outcome [1] 318189 0
Resting and worst pain using 11-point numerical rating scale (NRS), where 0=no pain; 10=worst imaginable pain
Timepoint [1] 318189 0
0, 8 weeks
Secondary outcome [2] 318190 0
Pressure pain threshold (KPa) will be measured over the affected and unaffected elbows using a handheld algometer with probe size 1cm2. Pressure will be applied at a rate of 40KPa/s until the first onset of pain. An average of three repetitions will be used in analysis.
Timepoint [2] 318190 0
0, 8 weeks
Secondary outcome [3] 318191 0
Cold pain threshold (C) will be measured over the affected and unaffected elbows using a Thermotest system. Temperature will be decreased at a rate of 1 degrees per second, until the first onset of pain. An average of three repetitions will be used in analysis.
Timepoint [3] 318191 0
0, 8 weeks
Secondary outcome [4] 318194 0
Conditioned pain modulation will be assessed by immersing the foot in iced water (12degrees celcius) for at least 2 minutes to deliver a pain intensity between 4 and 6 out of 10 on a 11-point NRS.
Timepoint [4] 318194 0
0, 8 weeks
Secondary outcome [5] 318195 0
Exercise induced analgesia will be assessed by performance of a submaximal endurance isometric exercise task of the wrist extensor muscles of the affected arm. Participants will hold a container filled with water to a load equivalent to 20% of the maximal voluntary wrist extensor capacity of the unaffected arm. Participants will be seated with the forearm resting on the edge of a table (approximately 90degrees elbow flexion, forearm pronation, 30 degrees wrist extension). Participants will be asked to maintain this position, until one of the following endpoints are reached: pain intensity >6 on a 11-point NRS, rating of perceived exertion =10 (Borg's RPE-CR10) or inability to maintain wrist position for >3s).
Timepoint [5] 318195 0
0 weeks

Eligibility
Key inclusion criteria
Aged 18 years or older;
Elbow pain for 6 weeks or more, which is greater than 2/10 on NRS for average pain intensity;
Clinical diagnosis of tennis elbow (lateral epicondylalgia): positive response to at least 2 of the following physical tests (resisted wrist, index or middle finger extension, stretch of wrist extensor muscles) and reduced pain free grip force.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Bilateral elbow pain;
Corticosteroid or other injection into elbow within preceding 6 months;
Surgery, fracture or major trauma to the neck or upper limb within preceding 1 year;
Clinical suspicion of other primary sources of lateral elbow pain (elbow pain exacerbated with neck movements or manual palpation, pain localised over the radiohumeral joint, sensory disturbance in the affected hand);
Concomitant neck or upper limb pain (other than tennis elbow) that they consider to be their most bothersome complaint;
Neurological, inflammatory or systemic conditions including daibetes, epilepsy, fibromyalgia or malignancy;
Pregnant or breastfeeding.

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)
Randomised allocation will be performed using concealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated sequence will be performed by a researcher not involved in the study. Randomisation will be stratified based on baseline worst pain ratings of 5 or less (low pain) or 6 or more (high pain).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was based on an assumption of a similar response of isometric exercise to that of a previous study of eccentric exercise (Croissier et al) (Effect size 1.0, Alpha 0.05, power 0.8) and allowing for 10% loss to followup.
Variables will be examined for normality.
Differences between groups will be tested using mixed factor ANOVA with factors: time (0,8 weeks), group (exercise, control).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/10/2015
Actual
29/09/2015
Date of last participant enrolment
Anticipated
Actual
31/07/2017
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 292199 0
University
Name [1] 292199 0
University of Queensland Research Scholarship
Country [1] 292199 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Health and Rehabilitation Sciences: Physiotherapy, St Lucia, Brisbane, Queensland, 4072
Country
Australia
Secondary sponsor category [1] 290876 0
None
Name [1] 290876 0
Address [1] 290876 0
Country [1] 290876 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293669 0
University of Queensland Medical Research Ethics
Ethics committee address [1] 293669 0
University of Queensland,
St Lucia, Brisbane, Queensland, 4072
Ethics committee country [1] 293669 0
Australia
Date submitted for ethics approval [1] 293669 0
01/07/2015
Approval date [1] 293669 0
25/09/2015
Ethics approval number [1] 293669 0
2015001134

Summary
Brief summary
In this project, we will study the clinical efficacy of an 8 week graded isometric home exercise program in patients with tennis elbow, by comparing it to a wait and see approach. Exercise is commonly prescribed to reduce pain and disability from tendinopathy, however the optimal type and dose of exercise is not clear. A recent systematic review identified only two clinical trials investigating the effects of isometric exercise in people with tennis elbow, with inconsistent findings. Neither of these studies quantified the exercise load, limiting conclusions regarding dose response. We will compare the effects of an 8 week home program of isometric exercise with a wait and see approach on global recovery, pain, disability and pain free grip strength.
Many patients with tennis elbow exhibit signs of central sensitisation, including widespread sensitivity to mechanical and thermal stimuli. It is not known whether exercise can improve the processes involved in central sensitisation. We will test the effects of 8 weeks of exercise on quantitative sensory tests and conditioned pain modulation. Exercise induced analgesia will be also evaluated at baseline using a submaximal (20% MVC) isometric endurance task.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60906 0
Dr Brooke Coombes
Address 60906 0
University of Queensland, School of Biomedical Sciences, St Lucia, Brisbane, Queensland, 4072
Country 60906 0
Australia
Phone 60906 0
+61437504508
Fax 60906 0
Email 60906 0
[email protected]
Contact person for public queries
Name 60907 0
Dr Brooke Coombes
Address 60907 0
University of Queensland, School of Biomedical Sciences, St Lucia, Brisbane, QLD, 4072
Country 60907 0
Australia
Phone 60907 0
+61437504508
Fax 60907 0
Email 60907 0
[email protected]
Contact person for scientific queries
Name 60908 0
Dr Brooke Coombes
Address 60908 0
University of Queensland, School of Biomedical Sciences, St Lucia, Brisbane, QLD 4072
Country 60908 0
Australia
Phone 60908 0
+61437504508
Fax 60908 0
Email 60908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All unidentified patient data will be shared on request
When will data be available (start and end dates)?
From publication of the study (no end date)
Available to whom?
On request to authors
Available for what types of analyses?
IPD available for meta-analysis
How or where can data be obtained?
By contacting the authors


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 5th International Scientific Tendinopathy Symposiu... [More Details] 369462-(Uploaded-23-11-2018-08-34-30)-Other results publication.docx

Documents added automatically
No additional documents have been identified.