Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000476437
Ethics application status
Approved
Date submitted
1/04/2016
Date registered
12/04/2016
Date last updated
12/10/2022
Date data sharing statement initially provided
12/10/2022
Date results provided
12/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Learning about your shoulder pain: a case series for patients with shoulder-related pain
Scientific title
A neuroscience approach to pain management for patients with rotator cuff syndrome: a case series
Secondary ID [1] 288905 0
Nil
Universal Trial Number (UTN)
U1111-1181-4830
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff syndrome 298239 0
Condition category
Condition code
Musculoskeletal 298378 298378 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298440 298440 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a pain education session with the main researcher (physiotherapist), based on a neuroscience approach to management of pain. Individual interviews will be held at the start and the end of the study, with baseline and follow-up measures at weekly intervals, using a “pre-, post-intervention” design.
Treatment of rotator cuff-related pain most commonly involves graduated exercises and manual therapy, with surgery considered when the conservative treatment is unsuccessful. These treatments currently focus on the local tissue pathology-pain model, thus on peripheral mechanisms of symptoms. However, there is not always a direct relationship between “pathology” and pain. It is, thus, unlikely that the peripheral-driven nociceptive mechanisms are solely responsible for the pain experience. Furthermore, patients’ beliefs and understanding of the causes of their (musculoskeletal) pain seem to be associated with better clinical outcomes. Besides the peripheral-driven mechanisms and potential local pathology, recent hypotheses indicate that central sensitization is also likely to contribute towards symptoms of patients with shoulder pain. Central sensitization relates to altered processing by increasingly sensitized dorsal horn cells in the spinal cord.
A neuroscience approach for management of central pain mechanisms includes pain education, cognition-targeted exercises and graded exposure to physical activity with the overall aim of decreasing the sensitivity of the central nervous system. Cognition-targeted exercises entail progressive exercises to improve muscle function and strength by including motor imagery (patients imagining that they are performing the exercise prior to physically performing them) and considering their beliefs and perception of the outcomes of the exercise, thereby decreasing fear of (re-)injury and avoidance of movement. Graded exposure to physical activity follows the same principles and are based on the patient's individual interests and capabilities: eg starting a walking programme with 10 minutes per day, and carefully grading increases in duration.
It currently is unclear how patients with rotator cuff-related pain understand their pain experience. It is also unclear whether the addition of pain education to usual physiotherapy will be of benefit these patients with rotator cuff-related pain, and whether this approach would be acceptable to the patients.
This study will be a case series whereby participants attend 6 physiotherapy sessions over 5 weeks at the School of Physiotherapy, University of Otago, Dunedin in a clinical research laboratory. The first, third and final sessions will last 1 and a half hrs, and the others will be a half to 1 hour.
Two qualitative studies will be nested in the study to explore (1) patients’ beliefs and experiences about their pain, and (2) their perception of the usefulness of the educational tool. The first interview will be undertaken during session 1 and the second interview at Session 6. The first interview will be conducted by the primary researcher, while the second interview will be conducted by a research assistant (also a physiotherapist). The second interview will explore the participants' acceptability and perceptions of the usefulness of the pain education as part of the management of their shoulder pain. Results of that interview will be used to modify the educational tools, if necessary, in preparation for potential future studies.
The educational tools (Powerpoint presentation, content of the one-hour face-to-face session, and hand-out) will be designed by the researchers based on current research evidence, prior to Session 3. Information gained from the first interview on the participants’ beliefs, will also be used for the final drafting of the educational tools to ensure that the content is specific for patients with shoulder pain.
Pain education will be provided by the main investigator (physiotherapist) by individual instruction during Session 3, supported by a Powerpoint presentation, and will last 1 hour. A paper hand-out will also be used, allowing participants to reflect on the information that is provided and how it may relate to their pain, to add notes and questions, and bring it to the follow-up sessions. During the three follow-up sessions (Session 4 to 6), they will have the opportunity to ask the physiotherapist for further clarification allowing individualised information to be provided. All six sessions will be held on an individual basis.
Intervention code [1] 294366 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297931 0
Shoulder Pain And Disability Index (SPADI), total score: indicating overall daily function related to shoulder activity.
Timepoint [1] 297931 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session
Secondary outcome [1] 322444 0
Glenohumeral range of motion, assessed with an inclinometer.
Timepoint [1] 322444 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session.
Secondary outcome [2] 322669 0
Isometric external and internal rotation muscle strength: force to pain onset and maximum force (Biodex dynamometer)
Timepoint [2] 322669 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session.
Secondary outcome [3] 322670 0
Quantitative sensory testing: general pain sensitivity will be assessed with pressure pain thresholds over the first interosseous muscle and at the insertion of the deltoid muscle (upper arm) using an Algometer; and temporal summation with sustained mechanical pressure on the thumb.
Timepoint [3] 322670 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session.
Secondary outcome [4] 322671 0
Shoulder function: with the Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) questionnaire.
Timepoint [4] 322671 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session.
Secondary outcome [5] 322672 0
Fear avoidance: with the Fear-Avoidance Beliefs Questionnaire (FABQ)
Timepoint [5] 322672 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session
Secondary outcome [6] 322673 0
Pain catastrophizing with Pain Catastrophizing Scale (PCS)
Timepoint [6] 322673 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session
Secondary outcome [7] 322674 0
Social functioning and general health: EQ-5D
Timepoint [7] 322674 0
On a weekly basis from 2 weeks prior to, to 3 weeks following the primary education session

Eligibility
Key inclusion criteria
(i) Men and women, aged 40 years and older, willing and able to participate;
(ii) primary complaint of shoulder pain with or without referral in the upper limb for at least 3 months
(iii range of motion largely preserved and
(iv) shoulder pain provoked consistently with resisted contractions into abduction and/or lateral rotation.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) shoulder surgery in the last 6 months,
(ii) known systemic inflammatory disorders,
(iii) cervical repeated movement testing affecting shoulder pain and/or range of movement,
(iv) pain or injuries of the arm other than the shoulder that limited function in the past 3 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This will be a case series with 10 patients. They will attend two sessions to determine baseline measures of the secondary outcomes measures. During the third session, the baseline measures will be repeated a third time, followed by the pain education session. This will be followed by three follow-up sessions (weekly) during which the secondary outcome measures will be repeated, and the participant will have opportunity to ask questions related to the pain information received and how it relates to their respective lives. Individual interviews will be conducted at the final follow-up session to determine the participants' acceptability and perceptions of the usefulness of the pain education as part of the management of their shoulder pain.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative outcome measures: Descriptive analysis with medians (inter-quartile ranges) for the three baseline and three follow-up sessions.
Qualitative interviews: General inductive approach.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/04/2016
Actual
3/05/2016
Date of last participant enrolment
Anticipated
31/05/2016
Actual
15/06/2016
Date of last data collection
Anticipated
Actual
29/07/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment outside Australia
Country [1] 7762 0
New Zealand
State/province [1] 7762 0
Otago

Funding & Sponsors
Funding source category [1] 293254 0
Other
Name [1] 293254 0
New Zealand Manipulative Physiotherapists Association (NZMPA)
Country [1] 293254 0
New Zealand
Funding source category [2] 293307 0
Other
Name [2] 293307 0
Physiotherapy New Zealand
Country [2] 293307 0
New Zealand
Primary sponsor type
Individual
Name
Dr Gisela Sole
Address
Center of Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 292055 0
Individual
Name [1] 292055 0
Dr Daniel Ribeiro
Address [1] 292055 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country [1] 292055 0
New Zealand
Secondary sponsor category [2] 292056 0
Individual
Name [2] 292056 0
Dr Prasath Jayakaran
Address [2] 292056 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of otago
Box 56
Dunedin
9054
Country [2] 292056 0
New Zealand
Other collaborator category [1] 278923 0
Individual
Name [1] 278923 0
Dr Craig Wassigner
Address [1] 278923 0
Department of Physical Therapy
University of East Tennessee
1276 Gilbreath Dr
Johnson City, TN 37604
Country [1] 278923 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294733 0
University of Otago Human (Health) ethics committee
Ethics committee address [1] 294733 0
Ethics committee country [1] 294733 0
New Zealand
Date submitted for ethics approval [1] 294733 0
22/01/2016
Approval date [1] 294733 0
16/03/2016
Ethics approval number [1] 294733 0
H16/013

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64870 0
Dr Gisea Sole
Address 64870 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 64870 0
New Zealand
Phone 64870 0
+64 3 4797936
Fax 64870 0
+64 3 4798414
Email 64870 0
gisela.sole@otago.ac.nz
Contact person for public queries
Name 64871 0
Gisela Sole
Address 64871 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 64871 0
New Zealand
Phone 64871 0
+64 3 4797936
Fax 64871 0
+64 3 4798414
Email 64871 0
gisela.sole@otago.ac.nz
Contact person for scientific queries
Name 64872 0
Gisela Sole
Address 64872 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 64872 0
New Zealand
Phone 64872 0
+64 3 4797936
Fax 64872 0
+64 3 4798414
Email 64872 0
gisela.sole@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Dmographic data, outcome measures and qualitative data.
When will data be available (start and end dates)?
Currently available, no end date.
Available to whom?
Researchers with a defined research proposal.
Available for what types of analyses?
For any purpose, approved by an ethics committee.
How or where can data be obtained?
Via email to the primary investigator, Dr Gisela Sole. gisela.sole@otago.ac.nz


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
No additional documents have been identified.