ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615000351516

Ethics application status

Approved

Date submitted

30/03/2015

Date registered

17/04/2015

Date last updated

6/07/2021

Date data sharing statement initially provided

6/07/2021

Date results information initially provided

6/07/2021

Type of registration

Retrospectively registered

Titles & IDs

Public title

Pain modulation characteristics in people with shoulder impingement and predictors of successful outcomes following physiotherapy treatment

Scientific title

Pain modulation characteristics in people with shoulder impingement and predictors of successful outcomes following physiotherapy treatment

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1168-8622

Trial acronym

Linked study record

Health condition

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

shoulder impingement

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will receive a 30-minutes session per week for 4 weeks which includes mobilization-with-movement technique, taping for the shoulder and therapeutic exercises to improve scapular control, strengthen scapular stabilizers and rotator cuff muscles and stretch for the anterior and posterior shoulder and scapular elevator. Participants will be informed to perform the therapeutic exercises at home daily which will take around 30 minutes. A physiotherapist with more than 4 years of practice will administer the manual therapy and physiotherapy at the clinic as well as improve the exercises weekly at each appointment. A shoulder diary will be used to monitor adherence to the exercises performed at home and also to monitor pain scores during the 28-days protocol.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

Twenty-two age- and gender-matched healthy participants with no history of shoulder or neck pain or injury will also be recruited as control group. The control group will not receive any intervention since they are not shoulder pain patients.

Control group

Active

Outcomes

Primary outcome [1]

Conditioned pain modulation (cold pressor test): Pressure pain threshold will be measured using the Somedic Digital Pressure algometer (Somedic AB, Farsta, Sweden) on the shoulder during the ice water bath applied on the opposite hand during 2 minutes.

Timepoint [1]

Patient group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements, and 1 assessment post-treatment (week 5).
Healthy group: 2 assessments on baseline performed with an interval of at least 48 hours between the measurements.

Primary outcome [2]

Thermal pain threshoulds (cold/heat): An electronic sensor (a small device 2 cm3 cube) will be placed over both shoulders and both knees using a velcro strap - TSA 2001-II (MEDOC).

Timepoint [2]

Primary outcome [3]

Temporal summation of pain (TS) using the 180 gr von Frey filament (North Coast Medical, San Jose, California) over both shoulder and both knees. Perceived pain intensity (in a 0-100 numerical rating scale) of a single pinprick stimulus will be compared with that of a series of 10 repetitive pinprick stimuli of the same physical intensity (1/s applied within an area of 1cm2).

Timepoint [3]

Secondary outcome [1]

Shoulder pain and disability index (SPADI)

Timepoint [1]

Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.

Secondary outcome [2]

Depression, anxiety and stress scale (DASS)

Timepoint [2]

Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.

Secondary outcome [3]

Quality of life (EuroQol questionnaire)

Timepoint [3]

Patient group: 1 assessment on baseline and 1 assessment post-treatment (week 5).
Healthy group: 1 assessments on baseline.

Eligibility

Key inclusion criteria

Shoulder pain in the anterosuperior aspect of the shoulder for longer than 6 weeks, and classified with shoulder impingement with at least 3 of the following findings: positive Neer impingement test, positive Hawkins-Kennedy test, positive Jobe test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation, pain with palpation of rotator cuff tendons, and pain in the C5 or C6 dermatome region.
Healthy subjects: no history of shoulder or neck pain or injury; no history of any kind of chronic pain.

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

History of cancer, previous fractures of the shoulder complex, recent shoulder surgery, corticosteroid injection into the glenohumeral joint within the previous 6 months, any neurological or auto-immune disorder, any recent shoulder dislocation, or if the shoulder pain was considered to be cervical in origin, history of fainting, dizziness, lightheadedness, chest pain or shortness of breath, or any history of cardiac disease.

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)

There is just one treatment for shoulder pain patients, therefore just one group of subjects treated which will be compared with healthy subjects. The purpose of the study are to characterise the sensory profile of subjects with shoulder impingment and to identify predictors for the success of the treatment based on the pain profile of the patient.

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

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

There is no comparable data from people with shoulder pain on which to base our sample size. Based on similar work in whiplash, 22 participants with shoulder pain and 22 age- and sex-matched healthy controls will be recruited. Sample size was calculated based on a power analysis (0.80), and the assumption of a 2.1 degrees Celsius (SD 2.4) difference in CPM functioning between groups.
Paired sample t-tests will be used to compare within-subject differences in CPM measured at 30- and 60-seconds after the cold pressor test. Reliability of measures for each group will be assessed using intraclass correlation coefficients (ICC 3,1). To compare differences between shoulder pain and control groups at baseline, Wilcoxon signed rank test will be used for measurements with skewed distributions or one-way ANOVA for equal distributions (HPT, CPT, PPT, cold pressor test and TS). Linear correlations will be performed to assess predictor factors for the successful treatment.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/02/2015

Actual

23/02/2015

Date of last participant enrolment

Anticipated

27/04/2015

Actual

6/04/2015

Date of last data collection

Anticipated

Actual

1/05/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Fundacao de Amparo a Pesquisa do Estado de Sao Paulo

Address [1]

R. Pio XI, 1500
Alto da Lapa
CEP 05468-901 Sao Paulo/SP

Country [1]

Brazil

Primary sponsor type

University

Name

Griffith University

Address

GRIFFITH UNIVERSITY
Parklands Drive
Southport, QLD 4222

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Fundacao de Amparo a Pesquisa do Estado de Sao Paulo

Address [1]

R. Pio XI, 1500
Alto da Lapa
CEP 05468-901 Sao Paulo/SP

Country [1]

Brazil

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Commitee

Ethics committee address [1]

Office for Research
Gold Coast campus
Room 4.25, The Learning Commons Building (G11)
Griffith University
Parklands Drive, Southport QLD 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/11/2014

Approval date [1]

14/01/2015

Ethics approval number [1]

AHS/65/14/HREC

Summary

Brief summary

There is a growing body of evidence of altered sensory processing in people with shoulder pain however it is not known which pain modulation pathway is affected in this population. It has also been reported that manual therapy techniques for the shoulder complex improve outcomes in patients with shoulder impingement compared to standard physiotherapy, sham or control interventions; however some findings suggest that a subgroup of individuals with shoulder pain may exist who will respond dramatically to these interventions. The aims of this study are to determine 1) the dominant pain modulation process in shoulder impingement individuals and 2) prognostic factors from the history, physical examination and pain modulation process in individuals with shoulder impingement who are likely to experience improvements following physiotherapy associated with manual therapy techniques. In this instance the population will be individuals with shoulder impingement symptoms and healthy controls. For the first aim of the study, all the subjects will be assessed twice at the baseline, with an interval of 48 hours between the measurements. For the second aim of the study, subjects with shoulder impingement will be treated during 4 weeks with manual therapy, physiotherapy and, when necessary, shoulder taping, and then reassessed after the 4-weeks rehabilitation program. The primary outcome measures will be heat pain threshold, cold pain threshold, cold pressor threshold, conditioned pain modulation and temporal summation of pain. The results of this study will contribute to our understanding of the dominant pain modulation process as mechanism for success in this technique and to guide physical therapists in selecting which patients with shoulder pain may experience improved outcomes following physiotherapy and manual therapy treatment. To date no scientific study has been conducted to investigate the pain modulation pathways in this population neither the predictive factors for successful outcomes concerning pain modulation in people with shoulder pain.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Melina Nevoeiro Haik

Address

PhD student at Griffith University
8 Gurrah avenue
Southport, QLD 4215.

Country

Australia

Phone

+61 0402553515

Fax

[email protected]

Contact person for public queries

Name

Mrs Melina Nevoeiro Haik

Address

PhD student at Griffith University
8 Gurrah avenue
Southport, QLD 4215.

Country

Australia

Phone

+61 0402553515

Fax

[email protected]

Contact person for scientific queries

Name

Prof Leanne Bisset

Address

Leanne Bisset PhD
Musculoskeletal Physiotherapist
Senior Lecturer
Office: G01 room 1.08
Menzies Health Institute Qld
Centre for Musculoskeletal Research
School of Allied Health Science
Griffith University
Parklands Drive
4215
Southport, Qld

Country

Australia

Phone

+617-55527717

Fax

[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?

measures of pain modulation.

When will data be available (start and end dates)?

Any time. There is no end date of the availability of the data when asking for that by emailing the corresponding author.

Available to whom?

To whom it may concern.

Available for what types of analyses?

Any kind of analysis.

How or where can data be obtained?

By e-mail (corresponding author): [email protected]

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			368279-(Uploaded-17-08-2020-06-01-20)-Basic results summary.docx
Plain language summary	No		1. Research questions: Is shoulder pain related to... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically