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Trial registered on ANZCTR

Registration number

ACTRN12617000126314

Ethics application status

Approved

Date submitted

18/01/2017

Date registered

24/01/2017

Date last updated

6/03/2019

Date data sharing statement initially provided

6/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating exercise based interventions for elbow pain.

Scientific title

What is the effect of two different muscle contraction types on pain in patients with lateral epicondylalgia?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

ISOLATE - ISOmetric exercise for LATeral Epicondylalgia

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lateral epicondylalgia

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will complete only one phase of the trial, and will be randomised as to whether they receive 1a or 1b, or 2a or 2b first. Each intervention involves a single session, taking approximately 90 minutes. Each session will be conducted by a physiotherpist (chief investigator). There will be a 1 week washout period between interventions.

Phase 1: Intervention (1a): Isometric wrist extension exercise 5 x 45 secs with 2 minute rest between repetitions.

Phase 2: Intervention (2a): Superior isometric exercise protocol as determined after phase 1 performed 5 x 45 secs with 2 minute rest between repetitions.
If after phase 1 no difference is shown between isometric protocols, the cheif investigator will make an a priori decision as to which exercise will be selected as for intervention 2a in phase 2)

Intervention code [1]

Treatment: Other

Comparator / control treatment

Phase 1: Intervention (1b): Isometric wrist extension and supination exercise 5 x 45 secs with 2 minute rest between repetitions. This exercise is different to 1a as it combines extension and supination movements (2 directions of motion)

Phase 2: Intervention (2b): Isotonic exercise matched to intervention 2a above for time under tension and load.

Control group

Active

Outcomes

Primary outcome [1]

Pain will be measured on a Numerical Rating Scale (o-10, where 0 equals no pain and 10 equals the worst possible pain), during a provocation test (resisted 3rd finger extension).

Timepoint [1]

Pain will be measured
-immediately following the performed intervention
-30 minutes after the performed intervention
-60 minutes after the performed intervention

Secondary outcome [1]

Maximum grip strength will be measured in wrist neutral with the elbow at 90 degrees, using a grip strength dynamometer. The participant will be instructed to squeeze the dynamometer as hard as they possibly can. 3 attempts will be made, and the average of these recorded.

Timepoint [1]

Grip strength will be measured
-immediately following the performed intervention
-30 minutes after the performed intervention
-60 minutes after the performed intervention

Secondary outcome [2]

Pain will be measured on a Numerical Rating Scale (o-10, where 0 equals no pain and 10 equals the worst possible pain), during maximal grip strength testing using a grip strength dynamometer.

Timepoint [2]

Pain during maximal grip strength will be measured:
-immediately following the performed intervention
-30 minutes after the performed intervention
-60 minutes after the performed intervention

Secondary outcome [3]

Transcranial Magnetic Stimulation (TMS) to measure corticospinal excitability.

Timepoint [3]

TMS testing will be carried out immediately following the completion of the exercise intervention.

Secondary outcome [4]

Transcranial Magnetic Stimulation (TMS) to measure short interval cortical inhibition (SICI).

Timepoint [4]

TMS testing will be carried out immediately following the completion of the exercise intervention.

Secondary outcome [5]

Transcranial Magnetic Stimulation (TMS) to measure long interval cortical inhibition (LICI).

Timepoint [5]

TMS testing will be carried out immediately following the completion of the exercise intervention.

Eligibility

Key inclusion criteria

Participants will be screened by researchers, and included if a diagnosis of current lateral epicondylalgia is confirmed, defined as - self reported localised pain over the common extensor origin at the lateral epicondyle with a loading task such as resisted 3rd digit extension. The loading task must be related to high intensity loading, as opposed to low load repetitive task (such as using a mouse/keyboard).

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

General Exclusions:
Any neurological symptoms including numbness, pins and needles or weakness
Past history of elbow surgery
Past history of cervical spine surgery
Psychiatric illness
Inability to speak, read or write English

TMS Exclusions:
Brain injury or any surgery to the brain (ie. metal implants in head/brain, outside the mouth)
Any metallic particles in the eye
Aneurysm clips
Cochlear implants
Noise induced hearing loss
Pace makers / spinal cord stimulators
Epilepsy of history of seizure activity (or family history in first degree relatives)

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)

Randomly drawn opaque envelopes. Assessors and data analysts will be blinded to participant allocation. Participants and researchers carrying out the intervention will be unable to be blinded.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation will occur generated by a random number generator in an excel spreadsheet. Randomisation will occur in blocks.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Crossover

Other design features

This study will be a two phase randomised trial, with a cross-over model.
Phase 1: 25 participants will be randomised as to whether they receive the phase 1 intervention or phase 1 comparator arm first. Subjects will complete the other arm one week later to allow for a wash out period.

Phase 2: A further 25 participants will be randomised as to whether they will receive the phase 2 intervention or phase 2 comparator arm first. Subjects will complete the other intervention one week later to allow for a wash out period.

Phase

Type of endpoint/s

Statistical methods / analysis

Data will be analysied by a single analyst blinded to the participant's intervention, and which timepoint is being analysed.
All data will be screened with the Shapiro-Wilk test, and if found to be normally distributed
means and standard deviations will be used, using one way ANOVA and post hoc t-test. A split-plot in time-repeated measures ANOVA will be used to compare the effect of each intervention on pain and grip strength. For non-normally distributed data the median and range will be used and data evaluated using the equivalent non parametric test (Kruskall Wallis), significance will be set at 0.05.

Recruitment

Recruitment status

Withdrawn

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

1/03/2017

Actual

Date of last participant enrolment

Anticipated

1/03/2019

Actual

Date of last data collection

Anticipated

8/03/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

La Trobe University

Address [1]

La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Research Ethics Comittee

Ethics committee address [1]

La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2016

Approval date [1]

08/03/2017

Ethics approval number [1]

HEC17-008

Summary

Brief summary

Lateral epicondylalgia (tendinopathy of the wrist extensors at the lateral epicondyle) is a common condition seen in middle aged people, and despite this, best management is poorly understood. Isometric exercises have been shown as effective in treating tendinopathies in the lower limb, however no-one has investigated the impact of different exercise protocols on immediate pain in the upper limb, and thus for lateral epicondylalgia. A two part cross-over study will examine whether different isometric protocols have better results on pain in this condition, and whether the superior isometric exercise is better than isotonic exercise for immediate impact on lateral epicondylalgia.

Trial website

Trial related presentations / publications

Public notes

TMS Protocol:
Baseline measures of corticospinal excitability, SICI and LICI will be obtained using single-pulse and paired-pulse TMS, respectively. The accuracy of TMS will be optimised by aligning the coil with reference markers on a tight fitting cap worn by participants and marked with a latitude–longitude matrix, positioned with reference to the nasion-inion and interaural lines.

Single-pulse stimulus-response curves (corticospinal excitability) will be obtained during low-level isometric contractions of the wrist extensor muscle group. Low-level contractions will be performed by contracting the wrist extensors maintaining the wrist in neutral while performing a 10% MVIC, which equates to 5±1% of root mean square (RMS) electromyography (rmsEMG) during MVIC. A 10% isometric muscle contraction is a non-painful task for someone with lateral epicondylalgia. Consistent muscle activation will be confirmed by recording pre-stimulus rmsEMG throughout the session. For a single stimulus-response curve, 10 stimuli will be delivered in 20% increments from 90% of the participant's active motor threshold (AMT) up to 190% of their AMT. The stimuli will be delivered using a ramped protocol. The amplitude of the motor-evoked potential (MEP) or slope of the stimulus-response curve represents corticospinal excitability.

SICI and LICI are probed by providing a subthreshold stimulus that activates inhibitory interneurons that synapse onto pyramidal neurons in the M1 and results in reduced number of action potentials by the subsequent suprathreshold stimulus. To quantify inhibition, 10 single-pulse stimuli and 10 short-interval paired-pulse stimuli will be delivered in random counterbalanced order. Intensity will be set at 120% of AMT, which will be determined during familiarisation and adjusted if there is a change in AMT. The conditioning stimulus for paired-pulse stimulation will be set at 80% of AMT, the interstimulus interval will be 3 ms to test SICI and 150ms to test LICI, and posterior to anterior current flow will be used to induce I3 waves. SICI and LICI are represented as a percentage ratio where high levels of inhibition are indicated by a low ratio. Therefore, an increase in the SICI or LICI percentage represents a reduction in inhibition.

Participants will be tested at the same time of day and the same day of the week. TMS will be delivered using two Magstim 200 2 stimulators connected via a Bistim unit (Magstim Co, Dyfed, UK) and a 110 mm concave double-cone coil (maximum output of 1.4 T). The motor hotspot for the extensor muscle (with posterior-induced to anterior-induced current flow in the cortex) will be determined and AMT will be established as the intensity at which at least 5 of 10 stimuli produced MEP amplitudes of greater than 200 µV recorded from the extensor muscle.  Valid EMG data for the forearm can be captured with surface electrodes.

The area of electrode placement will be shaved to remove fine hair, rubbed with an abrasive skin rasp to remove dead skin, and then cleaned with 70% isopropyl alcohol. Bipolar gel Ag-AgCl electrodes (8 mm diameter, model E258S; Biopac, Goleta, California, USA) will be placed over the extensor muscle (centre–centre interelectrode distance=2 cm). A grounding electrode strap will be placed over the wrist and subsequently used as a common reference for all electrodes. All cables will be fastened with tape to prevent movement artefact. The location of electrodes will be marked with a permanent marker by tracing around the electrode, and measured from ulnar styloid to lateral epicondyle to maximise consistency of electrode placement relative to the innervation zone. An impedance metre will be used to check that impedance does not exceed 10 kO prior to testing. Surface EMG (sEMG) signals will be amplified (×1000), bandpass filtered (high pass at 13 Hz, low pass at 1000 Hz), digitised online at 2 kHz for 500 ms, recorded and analysed using PowerLab 4/35 (ADInstruments, Bella Vista, Australia).

Pre-stimulus rmsEMG activity will be determined in the muscle, 100 ms prior to each TMS stimulus during pretesting and post-testing. Any trial in which prestimulus rmsEMG exceeds 5±1% of maximal rmsEMG will be discarded and the trial repeated. The surface rmsEMG will be calculated from a 500 ms segment that occurred during the asymptote of each maximal voluntary contraction (MVC) and was calculated as the amplitude of the RMS value.

Contacts

Principal investigator

Name

Dr Ebonie Rio

Address

La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 3 9479 3785

Fax

[email protected]

Contact person for public queries

Name

Ebonie Rio

Address

La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 3 9479 3785

Fax

[email protected]

Contact person for scientific queries

Name

Ebonie Rio

Address

La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora VIC 3086

Country

Australia

Phone

+61 3 9479 3785

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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