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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]

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)

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Hashemite University

Address [1]

Jordan, Zarqa, Abdallah Ghosheh, Az-Zarqa, Jordan

Country [1]

Jordan

Primary sponsor type

University

Name

The Hashemite University

Address

Jordan, Zarqa, Abdallah Ghosheh, Az-Zarqa, Jordan

Country

Jordan

Secondary sponsor category [1]

University

Name [1]

Curtin University

Address [1]

Kent St, Bentley WA 6102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Office of Research  and Development
Curtin University, Kent Street, Bentley, Perth, Western Australia 6102

GPO Box U1987
Perth Western Australia 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/01/2017

Approval date [1]

11/04/2017

Ethics approval number [1]

Summary

Brief summary

The proposed research is part of a PhD project in which we are investigating 2 natural responses that our nervous system uses to relieve pain called conditioned pain modulation (CPM) and manual therapy-induced pain modulation (MIPM). CPM refers to the capability of our body to inhibit the painfulness of one stimulus when another painful stimulus is also felt. For example, if you have a headache but then you stub your toe, the headache is forgotten. MIPM is the pain relieving effect you get following a manual therapy treatment. 

In this proposed experimental study, CPM and manual therapy analgesic responses will be assessed using CPM and MIPM assessment protocols, respectively, in patients with Lateral Epicondylalgia (LE; Tennis Elbow). Participants will initially undergo a through clinical screening to confirm that eligibility criteria are met.  Eligible participants will then undergo CPM assessment followed by MIPM assessment, with a 15mins rest in between.

Both protocols will use pressure pain threshold (PPT) as the main outcome measure to quantify the analgesic changes in response CPM and MIPM stimuli. The PPT values will then be analysed to determine if there is an association between the CPM and MIPM responses in this patient population. If both forms of pain modulation demonstrate a similar pattern of response, this would suggest a common underlying mechanism of action.  

This research may provide a base from which to investigate the possibility of enhancing MIPM effects by combining manual therapy with other treatment modalities. It will therefore extend our knowledge of manual therapy induced analgesia.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372292-Part One_Aerobic Ex's Study Protocol_11Dec16 (3).docx (Protocol)

Attachments [2]

/AnzctrAttachments/372292-Aerobic Study Proposal_11Dec-16.docx (Protocol)

Attachments [3]

/AnzctrAttachments/372292-Aerobic Study_Patient Information Sheet_11Dec16 (1).docx (Participant information/consent)

Attachments [4]

/AnzctrAttachments/372292-Aerobic Study Consent Form_11Dec16.docx (Participant information/consent)

Contacts

Principal investigator

Name

Prof Tony Wright

Address

Curtin University
Faculty of Health Sciences
School of Physiotherapy and Exercise Science
Bentley Campus 408.3509
Kent Street Bentley, WA 6102

Country

Australia

Phone

+61 8 9266 3675

Fax

+61 8 9266 3699

T.Wright@curtin.edu.au

Contact person for public queries

Name

Tony Wright

Address

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

Australia

Phone

+61 8 9266 3675

Fax

+61 8 9266 3699

T.Wright@curtin.edu.au

Contact person for scientific queries

Name

Tony Wright

Address

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

Australia

Phone

+61 8 9266 3675

Fax

+61 8 9266 3699

T.Wright@curtin.edu.au

Data sharing statement

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

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

Source	Title	Year of Publication	DOI
Embase	The association between conditioned pain modulation and manipulation-induced analgesia in people with lateral epicondylalgia.	2019	https://dx.doi.org/10.1097/AJP.0000000000000696

N.B. These documents automatically identified may not have been verified by the study sponsor.

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