Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000218392
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
9/02/2017
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Association between the analgesic effects of Conditioned Pain Modulation (CPM) and Manipulation induced Pain Modulation (MIPM)
Scientific title
Association between the analgesic effects of Conditioned Pain Modulation (CPM) and Manipulation Induced Pain Modulation (MIPM)
Secondary ID [1] 291094 0
Nil
Universal Trial Number (UTN)
U1111-1192-5296
Trial acronym
Linked study record
ACTRN12617000219381p

Health condition
Health condition(s) or problem(s) studied:
Tennis Elbow (or Lateral Epicondylalgia: LE) 301905 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301570 301570 0 0
Physiotherapy
Musculoskeletal 301571 301571 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once eligibility criteria are confirmed, each participant will be asked to attend for preliminary assessment with CPM and MIPM assessment protocols in a single session. CPM and MIPM assessment protocols are described as follows:

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.

The CPM assessment protocol will be followed by the MIPM assessment protocol with a rest period of 15 min in between. All outcome measures will be performed by the same researcher applying the CPM and the manual therapy stimuli. All instructions will be standardized. Subjects will be asked to avoid physiotherapy and other forms of physical exercise on the day of assessment.

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, including the eligibility testing, 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] 297081 0
Rehabilitation
Intervention code [2] 297082 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300979 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] 300979 0
PPT will be tested in both CPM and MIPM assessment protocols:

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] 331317 0
Pain free grip (PFG)
PFG will provide additional measures of the MIPM effect. It 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] 331317 0
PFG will be carried out at baseline and then repeated immediately after the manual therapy stimulus (C5/6 contralateral lateral glide mobilisation).

Secondary outcome [2] 331318 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] 331318 0
ULNDT will be carried out at baseline (prior to cervical manual therapy stimulus) and then repeated immediately after the conditioning stimulus (C5/6 contralateral lateral glide mobilisation)

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
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 y)
- 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a quasiexperimental single-group study. Not a randomised controlled trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculations were determined using Stata/IC (version 15.0: StataCorp LLC, TX). The aim of the study was to evaluate the correlation between PPT measures obtained duringtheMIAandCPMassessmentprotocols.Asthereisno current literature that quanti?es the correlation between MIA and CPM effects we estimated that the correlation coef?cient between PPT measures for these variables would be 0.35, just above the cut-off for a moderate correlation. In determining our sample size we set a at 0.05 and power at 0.80 to detect a correlation coef?cient of 0.35. The minimum required sample size for a one-sample correlation test was 62. Allowing for potential drop-outs, we recruited 70 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2017
Actual
1/10/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
30/06/2018
Date of last data collection
Anticipated
30/06/2018
Actual
30/06/2018
Sample size
Target
68
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295531 0
University
Name [1] 295531 0
The Hashemite University
Country [1] 295531 0
Jordan
Primary sponsor type
University
Name
The Hashemite University
Address
Jordan, Zarqa, Abdallah Ghosheh, Az-Zarqa, Jordan
Country
Jordan
Secondary sponsor category [1] 294352 0
University
Name [1] 294352 0
Curtin University
Address [1] 294352 0
Kent St, Bentley WA 6102
Country [1] 294352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296852 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 296852 0
Ethics committee country [1] 296852 0
Australia
Date submitted for ethics approval [1] 296852 0
23/01/2017
Approval date [1] 296852 0
11/04/2017
Ethics approval number [1] 296852 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1447 1447 0 0
/AnzctrAttachments/372292-Part One_Aerobic Ex's Study Protocol_11Dec16 (3).docx (Protocol)
Attachments [2] 1448 1448 0 0
/AnzctrAttachments/372292-Aerobic Study Proposal_11Dec-16.docx (Protocol)
Attachments [3] 1449 1449 0 0
/AnzctrAttachments/372292-Aerobic Study_Patient Information Sheet_11Dec16 (1).docx (Participant information/consent)
Attachments [4] 1450 1450 0 0
/AnzctrAttachments/372292-Aerobic Study Consent Form_11Dec16.docx (Participant information/consent)

Contacts
Principal investigator
Name 72226 0
Prof Tony Wright
Address 72226 0
Curtin University
Faculty of Health Sciences
School of Physiotherapy and Exercise Science
Bentley Campus 408.3509
Kent Street Bentley, WA 6102
Country 72226 0
Australia
Phone 72226 0
+61 8 9266 3675
Fax 72226 0
+61 8 9266 3699
Email 72226 0
[email protected]
Contact person for public queries
Name 72227 0
Tony Wright
Address 72227 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 72227 0
Australia
Phone 72227 0
+61 8 9266 3675
Fax 72227 0
+61 8 9266 3699
Email 72227 0
[email protected]
Contact person for scientific queries
Name 72228 0
Tony Wright
Address 72228 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 72228 0
Australia
Phone 72228 0
+61 8 9266 3675
Fax 72228 0
+61 8 9266 3699
Email 72228 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
The study was completed and it was not in plan and these data needs to be published (copyright)


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
EmbaseThe association between conditioned pain modulation and manipulation-induced analgesia in people with lateral epicondylalgia.2019https://dx.doi.org/10.1097/AJP.0000000000000696
N.B. These documents automatically identified may not have been verified by the study sponsor.