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Trial registered on ANZCTR


Registration number
ACTRN12617000219381
Ethics application status
Approved
Date submitted
30/01/2017
Date registered
9/02/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of aerobic exercise on Conditioned Pain Modulation (CPM) and Manipulation Induced Pain Modulation (MIPM) effects in participants with tennis elbow.
Scientific title
The influence of aerobic exercise on Conditioned Pain Modulation (CPM) and Manipulation Induced Pain Modulation (MIPM) effects in participants with tennis elbow.
Secondary ID [1] 291004 0
Nil known
Universal Trial Number (UTN)
U1111-1192-0156
Trial acronym
Linked study record
ACTRN12617000218392p

Health condition
Health condition(s) or problem(s) studied:
Tennis Elbow (or Lateral Epicondylalgia; LE) 301773 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301465 301465 0 0
Physiotherapy
Musculoskeletal 301469 301469 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Research Study Procedure:
A randomized between-group design will be used in this study, Participants will be first randomized to receive either low (50% VO2 max) or moderate intensity (75% VO2 max) aerobic exercise . Participants in each group will be initially tested for pressure pain threshold (PPT) at both elbow and wrist measurement sites. They will then be randomized to undergo a precondition CPM assessment protocol and an MIPM assessment protocol, in two separate test sessions (i.e. two study days) separated by three days. All CPM and MIPM protocols will be performed by the same assessor who will remain blinded to the level of aerobic exercise subjects are completing. Following completion of the aerobic exercise, all subjects will be reassessed for CPM and MIPM.

Description of Aerobic Exercise Intervention:
All participants will undergo a 15 min session of stationary cycling at 2 different intensities: 75% or 50% VO2 heart rate reserve (HRR). Prior to the beginning of the session, the target heart rate (THR) matching 75% or 50% VO2 max will be determined using the Karvonen formula: THR = ((maximal HR - resting HR) × %Intensity) + resting HR), where maximal HR = 220-age. Heart rate will be regularly observed during rest and exercise using a heart rate monitor, which will be fitted at the start of the session. The targeted exercise intensity level will be achieved through controlling the speed and the resistance of the cycle ergometer. Participants will initially start warming up by cycling gradually to reach the desired exercise intensity during the first 5mins, they will then continue cycling for the following 10mins while maintaining the exercise intensity at 75%Vo2max. The heart rate will be continuously monitored to ensure that the exercise intensity is achieved and adequately maintained during the session. This intervention will be conducted under standardized conditions by a physiotherapy student, who is under the supervision of senior physiotherapy staff at Curtin University Physiotherapy Clinic.

Conditioned Pain Modulation (CPM) Assessment Protocol
Test stimulus: Pressure Pain Threshold (PPT) will be used as the test stimulus and measured by an electronic digital algometer (Somedic AB, Sweden). Participants will sit on a chair of adjustable height so the forearm is comfortably supported. PPT will be performed two marked locations of the affected arm, which will be positioned in pronation on a table. PPT will be tested at baseline prior to cold water immersion, after 1 min during immersion, and 1 min post immersion. At each time point, PPT will be measured three times with 10-15 s rest intervals in between. The mean value of the three measurements at each point will be used for analysis.

Conditioning stimulus: The Cold Pressor Test (CPT) will be used as a conditioning stimulus to elicit the CPM response. The unaffected hand will be submerged 4 inches above the wrist crease in a cold water bath, with a temperature maintained at 7 degrees Celsius for a period of 2 min The water bath contains a mix of water and ice and it is supplied with a circulating pump to ensure uniformity of water temperature at the skin. The difference between PPT measurements taken before and after water immersion represents the CPM effect. This will be quantified as the percentage change in PPT relative to the baseline measure. Separate percentage change measures will be obtained for the wrist and elbow sites.

Manipulation Induced Pain Modulation (MIPM) Assessment Protocol
Test stimulus: PPT will be the test stimulus. The Pain Free Grip (PFG) test, Upper Limb Neurodynamic Test (ULNDT) with radial nerve bias and measures of PPT at both test sites will be carried out at baseline and then repeated immediately after the conditioning stimulus (C5/6 contralateral lateral glide mobilisation). Testing will be performed with the participants lying supine on a plinth. PFG and UNLDT will provide additional measures of the MIPM effect.

Conditioning stimulus: a grade III passive oscillatory, contralateral lateral glide (CLG) mobilisation of the C5/6 motion segment of the cervical spine will be used to induce MIPM The participant will be comfortably lying supine with arms by their side and instructed to report if they feel any discomfort or pain during execution of the mobilisation. In contrast to CPM this conditioning stimulus should be painless. The therapist will depress the scapulae with one hand, while the other hand cradles the occiput and neck above the C5/6 segment. Using the cradling hand, the therapist will apply a grade III passive oscillatory CLG directed towards the unaffected upper limb. The CLG stimulus will be performed for 60 s, and will be repeated three times, with 60-s rest periods in between (5 min total). The difference between PTT measurements taken before and after CLG mobilisation represents the MIPM effect. This will be quantified as the percentage change in PPT relative to the baseline measure. Separate percentage change measures will be obtained for the wrist and elbow sites and the PFG and ULNDT measures.

A Physiotherapy PhD student, who has a masters degree in manual therapy and 8 years post masters experience in manual therapy, will conduct all assessment procedures previously described. Experimental procedures will be conducted at the Physiotherapy Clinic at the School of Physiotherapy and Exercise Science at the Bentley campus of Curtin University.



Intervention code [1] 296970 0
Rehabilitation
Intervention code [2] 297084 0
Treatment: Other
Comparator / control treatment
The study will include 2 experimental conditions (interventions). The effect of 2 different intensities of aerobic exercises (50% and 75%) on CPM and MIPM will be determined and then compared.
Control group
Active

Outcomes
Primary outcome [1] 300862 0
Pressure Pain Threshold (PPT)
PPT will be measured using an electronic digital algometer (Somedic AB, Sweden) with standard methodology. The assessor will identify the most tender point at the lateral aspect of the affected elbow by palpation. He will also identify a mid-point on the posterior aspect of the wrist, 2 cm proximal to the wrist crease. These measurement sites will then be marked. The participant will be sitting on a chair of adjustable height so the forearm is comfortably positioned in pronation on a table. A 1 cm² algometer tip will be applied perpendicularly over each marked site by the assessor and the pressure stimulus applied at a standard rate of 40 kPa/s. The participant will be instructed to push a control switch at the moment they perceive the pressure becoming painful. PPT measures are the pressure value (kPa) recorded from the algometer. The test procedure will first be conducted at the unaffected forearm for familiarization. Three PPT measurements will be taken at each site on the symptomatic side with 10-15 s intervals between each.
Timepoint [1] 300862 0
For this study, PPT will be tested immediately prior to the aerobic exercise intervention. It will also be tested during CPM and MIPM assessment protocols (after aerobic exercise) as follows:

CPM: PPT will be tested at baseline prior to cold water immersion, after 1 min during immersion, and 1 min post immersion. At each time point, PPT will be measured three times with 10-15 s rest intervals in between.

MIPM: PPT will be carried out at baseline (before manual therapy stimulus) and then repeated immediately after the manual therapy stimulus (C5/6 contralateral lateral glide mobilisation)
Secondary outcome [1] 331066 0
Pain free grip (PFG)
PFG will provide additional measures of the MIPM effect. For this study, PFG will be measured with an electronic digital dynamometer (MIE, Medical Research Ltd.) using standard methodology. The participant will be lying supine with the arm by their side positioned in elbow extension and forearm pronation. They will then be requested to squeeze the dynamometer handles until they first feel their lateral elbow pain, and then to stop the squeezing action. The PFG force value is then recorded from the digital display. The PFG test will be performed three times with 10-20 s rest intervals in between.
Timepoint [1] 331066 0
PFG will be carried out during MIPM assessment protocol after aerobic exercise. In MIPM assessment protocol PFG will be tested right prior to cervical manual therapy (C5/6 contralateral lateral glide mobilisation) and then repeated immediately after the manual therapy stimulus right following PPT testing.
Secondary outcome [2] 331067 0
Upper limb neurodynamic test (ULNDT) with radial nerve bias
The upper limb neurodynamic test (ULNDT) with radial nerve bias will be used to assess primarily neural mobility of the forequarter. Painfree range of motion in the test is restricted in patients with Tennis Elbow. The participant’s arm will be progressively positioned in scapular depression and protraction, elbow extension, internal rotation, forearm pronation, wrist and finger flexion. Scapular depression will be sustained while performing the test. The shoulder will then be slowly taken into abduction. The participant will be instructed to depress a switch at the onset of pain with this movement and the arm will be returned to the start position. The shoulder abduction range at the onset of pain will be measured using an M180 twin axis electrogoniometer (Penny & Giles, United Kingdom) positioned over the anterior shoulder. Three readings will be taken with 20-30 s intervals in between. UNLDT will provide additional measures of the MIPM effect.
Timepoint [2] 331067 0
For this study, ULNDT will be carried out during MIPM assessment protocol and after aerobic exercise. In MIPM, ULNDT is tested prior to cervical manual therapy stimulus and then repeated immediately after the conditioning stimulus (C5/6 contralateral lateral glide mobilisation) just following PFG testing.

Eligibility
Key inclusion criteria
Inclusion criteria
Unilateral elbow pain > 6 weeks reproduced on at least 2 of the following tests:
Palpation of the lateral epicondyle
Passive stretch of wrist extensors
Isometric testing of the wrist extensors
Resisted hand gripping using a dynamometer
Middle finger extension test
Upper limb neurodynamic test-radial nerve bias

To confirm that the eligibility criteria are met, a thorough clinical examination of all subjects will be carried out prior to commencing the study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Neurological and radicular dysfunctions
Steroid injection into the elbow (previous 1 month)
History of fracture/surgery in the forequarter (past 2 yr)
Contraindications to cold application
Inability to communicate in English
History of generalized arthritis
Present or chronic use of anti-depressants

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)
Eligible subjects will be randomized to receive either low (50% VO2 max) or moderate intensity (75% VO2 max) aerobic exercise on a cycle ergometer. They will then be randomized to undergo a CPM assessment protocol or an MIPM assessment protocol, in two separate test sessions (i.e. two study days) separated by three days. These randomisation processes will be managed by contacting the Physiotherapy Clinic supervisor, the holder of the allocation schedule, at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
All participants are assigned to receiving two different parameters of the same intervention throughout the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample calculations: Based on data from a major clinical trial comparing corticosteroid injections and physiotherapy management of tennis elbow (Coombes et al. 2013) the minimal clinical important difference (MCID) in pressure pain threshold at the elbow was considered to be 88 kPa (Coombes and Vicenzino personal communication 2017). In estimating our sample size we used a difference value of 50 kPa in elbow PPT with a pooled standard deviation of 73.235 kPa (based on preliminary data from our pilot study (HRE2016-181-01)) resulting in an effect size difference of 0.68. An a priori power analysis (alpha = 0.05, beta = 0.80) indicated a required sample size of 68 (34 per group).

Analysis: PPT measures of CPM and MIPM will be obtained for the wrist and elbow sites. These measures will be obtained at baseline and immediately following 15mins of moderate or low intensity aerobic exercise. Linear mixed models will be performed to evaluate differences in CPM and MIPM effects between the group receiving the low intensity aerobic exercise and the group receiving the moderate intensity aerobic exercise. Post aerobic CPM and MIPM measures will be included as covariates. If there is a difference in the level of CPM and MIPM analgesia represented by PPT between participants in both experimental groups then this may suggest that both forms of analgesia share similar neurophysiological mechanisms in the nervous system. Moreover, a hypothesis regarding correlation between MIPM and CPM analgesic effects will be tested using a Pearson’s correlation test to evaluate the association between change in PPT at both test sites during CPM and MIPM assessment protocols.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2017
Actual
2/10/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
25/06/2018
Date of last data collection
Anticipated
6/07/2018
Actual
25/06/2018
Sample size
Target
68
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295430 0
University
Name [1] 295430 0
The Hashemite University
Country [1] 295430 0
Jordan
Primary sponsor type
University
Name
The Hashemite University
Address
Jordan, Zarqa, Abdallah Ghosheh, Az-Zarqa, Jordan
Country
Jordan
Secondary sponsor category [1] 294254 0
None
Name [1] 294254 0
Address [1] 294254 0
Country [1] 294254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296762 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 296762 0
Ethics committee country [1] 296762 0
Australia
Date submitted for ethics approval [1] 296762 0
23/01/2017
Approval date [1] 296762 0
31/08/2017
Ethics approval number [1] 296762 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1393 1393 0 0
/AnzctrAttachments/372232-Aerobic Study Proposal_11Dec-16.docx (Protocol)
Attachments [2] 1394 1394 0 0
/AnzctrAttachments/372232-Aerobic Study_Patient Information Sheet_11Dec16.docx (Participant information/consent)
Attachments [3] 1395 1395 0 0
/AnzctrAttachments/372232-Aerobic Study Consent Form_11Dec16.docx (Participant information/consent)
Attachments [4] 1396 1396 0 0
/AnzctrAttachments/372232-Aerobic Study_Pre-exercise_Screening_11Dec16.pdf (Other)
Attachments [5] 1397 1397 0 0
/AnzctrAttachments/372232-GPAQ_EN_11Dec16.doc (Other)
Attachments [6] 1398 1398 0 0
/AnzctrAttachments/372232-GPAQ_GenericShowCards_11Dec16.doc (Other)
Attachments [7] 1442 1442 0 0
/AnzctrAttachments/372232-Part Two_Aerobic Ex's Protocol_11Dec16 (1).docx (Protocol)

Contacts
Principal investigator
Name 71986 0
Prof Tony Wright
Address 71986 0
School of Physiotherapy and Exercise Science (Building 408.3509)
Faculty of Health Sciences
Bentley Campus
Curtin University
GPO Box U1987
Perth, WA 6845
Australia
Country 71986 0
Australia
Phone 71986 0
+61 8 92663675
Fax 71986 0
+61 8 92663699
Email 71986 0
T.Wright@curtin.edu.au
Contact person for public queries
Name 71987 0
Tony Wright
Address 71987 0
Curtin University
Faculty of Health Sciences
School of Physiotherapy and Exercise Science
Bentley Campus 408.3509
Kent Street Bentley, WA 6102
GPO Box U1987
Perth, WA 6845
Australia
Country 71987 0
Australia
Phone 71987 0
+61 8 92663675
Fax 71987 0
+61 8 92663699
Email 71987 0
T.Wright@curtin.edu.au
Contact person for scientific queries
Name 71988 0
Tony Wright
Address 71988 0
Curtin University
Faculty of Health Sciences
School of Physiotherapy and Exercise Science
Bentley Campus 408.3509
Kent Street Bentley, WA 6102
GPO Box U1987
Perth, WA 6845
Country 71988 0
Australia
Phone 71988 0
+61 8 92663675
Fax 71988 0
+61 892663699
Email 71988 0
T.Wright@curtin.edu.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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