Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001676404
Ethics application status
Approved
Date submitted
25/08/2016
Date registered
6/12/2016
Date last updated
12/07/2021
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial comparing three different physiotherapy interventions to treat rotator cuff tendinopathy/subacromial pain syndrome.
Scientific title
A pilot randomised controlled trial to compare isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy.
Secondary ID [1] 289819 0
None
Universal Trial Number (UTN)
Trial acronym
The SPaRC Trial
(Subacromial Pain and Rotator Cuff)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial Pain Syndrome 299743 0
Rotator Cuff Tendinopathy 300104 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299939 299939 0 0
Physiotherapy
Musculoskeletal 299940 299940 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are randomly assigned to one of three intervention groups:
(i) isometric exercises
(ii) isotonic concentric exercises
(iii) isotonic eccentric exercises

All groups will receive similar physiotherapy treatment directed at improving postural deficits, scapular control, shoulder muscle strength and flexibility. The variation in the intervention between the groups will be the specific type of rotator cuff strengthening exercises incorporated into the rehabilitation program: these will involve either (i) isotonic concentric; (ii) isotonic eccentric or (iii) isometric contractions, taught and prescribed in accordance with current best evidence.

The treatment sessions will occur once per week over 4 consecutive weeks (weeks 2-5).

Exercises:
Treatment 1: re-training of scapular/humeral head movement patterns.
Scapular control exercises will be patient specific and relate to symptom modification of scapular postures identified at assessment including scapular rotation and/or tilt. Once the patient has learned how to re-position the scapular so that for example, downward rotation and anterior tilt is corrected, they will perform scapular muscle strengthening exercises including (i) modified shrug drills in standing with arm abducted <30 degrees with elastic resistance band as tolerated.
Treatment 2: rotator cuff strengthening (external rotation) exercises. These will be performed in standing, arm by side, elbow flexed to 90 degrees, using (i) elastic resistance band for concentric and eccentric and (ii) rigid band for isometric contractions.

Treatment 3: rotator cuff strengthening (internal rotation) exercises. These will be performed in standing, arm by side, elbow flexed to 90 degrees, using (i) elastic resistance band for concentric and eccentric and (ii) rigid band for isometric contractions.

Treatment 4: Flexibility exercises including (i) an anterior shoulder stretch (standing in corner of room or using door jamb) and (ii) thoracic extension range of motion exercises in either a) sitting or b) supine lie over rolled up towel. Also posterior muscle building including (iii) standing rows at 45 and 90 degrees using elastic resistance band as tolerated.

The above exercises will be taught during the physiotherapy sessions and then performed independently and daily as part of a home exercise program with dose dependent on exercise type and specifically:

1) Scapular retraining (motor relearning) exercises, scapular shrugs and standing rows: 1-2 times daily, 1-2 sets of 20, 5-10 second rest in between each set.
Progression of sets, repetitions and load dependent on individual participant ability to achieve control.

2) Rotator Cuff strengthening exercises: varies with muscle contraction group:
Isotonic: 1-2 times daily, 1-2 sets of 20 repetitions, 5-10 second rest in between each set;
Isometric: 1-2 times daily, 1 set of 3-5 repetitions with 10 second isometric hold, 5 second rest in between each hold. 1-2 times daily.

3) Flexibility: all exercises 1-2 sets daily; stretch held for 15 seconds and repeated 2-4 times with a 5-10 second rest in between each stretch, 1-2 times daily. Thoracic mobility:. 1 set of 10 reps with 5 second hold and 5-10 second rest in between sets. 1-2 times daily.

Both scapular retraining and rotator cuff strengthening exercises will be taught/undertaken in standing but temporarily modifiable to side lie/prone positions dependent on patient symptoms and/or ability to control the scapular/humeral head in the standing position.

The home program will take 15-20 minutes to complete each day with sets and repetitions as described above.

At week 6 patients will be provided with an exercise sheet that they will use from week 6-12. The exercise sheet is the same for each group and will include most of the exercises taught and practiced during the physiotherapy intervention, as well as additional exercises designed to further increase strength, range and flexibility. Until they receive this exercise sheet at week 6, patients undertake their group specific home exercise program that consists only of the exercises they are taught during their physiotherapy sessions. The exercise sheet given at week 6 replaces the previous sheet. It incorporates most of the exercises already performed as part of the home exercise program during weeks 2-6 but progresses these so they are no-longer group specific.
Specific exercises detailed on the exercise sheet include:
1): scapular setting through progressive range of motion;
2) rotator cuff internal/external rotation with elastic resistance band as tolerated
3): posterior muscle strengthening - (i) standing rows with resistance band as tolerated at 45, 90 and 120 degrees; single bent forward row with elastic resistance band as tolerated.
4): flexibility exercises: (i) thoracic mobility in sitting, (ii) thoracic mobility in lie over rolled towel; (iii) anterior shoulder stretch (pectorals in door jamb);

At week 9, they will attend a check-review to ensure compliance with the exercise sheet.

The assessment and treatment sessions will be carried out by a designated musculoskeletal Physiotherapist at each site, with at least 5 years experience. Prior to recruitment of participants into the study, all clinicians involved in assessment and treatment delivery will receive training in the techniques to be used in each group, as per the study protocol. All treatment interventions will be recorded on standardised report forms. The treatment sessions will be individual 1: 1 sessions lasting up to 30 minutes per session.
Intervention code [1] 295738 0
Rehabilitation
Comparator / control treatment
Participants are randomly assigned to one of three intervention groups:
(i) isometric exercises
(ii) isotonic concentric exercises
(iii) isotonic eccentric exercises

All groups will receive similar physiotherapy treatment directed at improving postural deficits, scapular control, shoulder muscle strength and flexibility. The variation in the intervention between the groups will be the specific type of rotator cuff strengthening exercises incorporated into the rehabilitation program: these will involve either (i) isotonic concentric; (ii) isotonic eccentric or (iii) isometric contractions, taught and prescribed in accordance with current best evidence.

The treatment sessions will occur once per week over 4 consecutive weeks (weeks 2-5).

Exercises:
Treatment 1: re-training of scapular/humeral head movement patterns.
Scapular control exercises will be patient specific and relate to symptom modification of scapular postures identified at assessment including scapular rotation and/or tilt. Once the patient has learned how to re-position the scapular so that for example, downward rotation and anterior tilt is corrected, they will perform scapular muscle strengthening exercises including (i) modified shrug drills in standing with arm abducted <30 degrees with elastic resistance band as tolerated.
Treatment 2: rotator cuff strengthening (external rotation) exercises. These will be performed in standing, arm by side, elbow flexed to 90 degrees, using (i) elastic resistance band for concentric and eccentric and (ii) rigid band for isometric contractions.

Treatment 3: rotator cuff strengthening (internal rotation) exercises. These will be performed in standing, arm by side, elbow flexed to 90 degrees, using (i) elastic resistance band for concentric and eccentric and (ii) rigid band for isometric contractions.

Treatment 4: Flexibility exercises including (i) an anterior shoulder stretch (standing in corner of room or using door jamb) and (ii) thoracic extension range of motion exercises in either a) sitting or b) supine lie over rolled up towel. Also posterior muscle building including (iii) standing rows at 45 and 90 degrees using elastic resistance band as tolerated.

The above exercises will be taught during the physiotherapy sessions and then performed independently and daily as part of a home exercise program with dose dependent on exercise type and specifically:

1) Scapular retraining (motor relearning) exercises, scapular shrugs and standing rows: 1-2 times daily, 1-2 sets of 20, 5-10 second rest in between each set.
Progression of sets, repetitions and load dependent on individual participant ability to achieve control.

2) Rotator Cuff strengthening exercises: varies with muscle contraction group:
Isotonic: 1-2 times daily, 1-2 sets of 20 repetitions, 5-10 second rest in between each set;
Isometric: 1-2 times daily, 1 set of 3-5 repetitions with 10 second isometric hold, 5 second rest in between each hold. 1-2 times daily.

3) Flexibility: all exercises 1-2 sets daily; stretch held for 15 seconds and repeated 2-4 times with a 5-10 second rest in between each stretch, 1-2 times daily. Thoracic mobility:. 1 set of 10 reps with 5 second hold and 5-10 second rest in between sets. 1-2 times daily.

Both scapular retraining and rotator cuff strengthening exercises will be taught/undertaken in standing but temporarily modifiable to side lie/prone positions dependent on patient symptoms and/or ability to control the scapular/humeral head in the standing position.

The home program will take 15-20 minutes to complete each day with sets and repetitions as described above.

At week 6 patients will be provided with an exercise sheet that they will use from week 6-12. The exercise sheet is the same for each group and will include most of the exercises taught and practiced during the physiotherapy intervention, as well as additional exercises designed to further increase strength, range and flexibility. Until they receive this exercise sheet at week 6, patients undertake their group specific home exercise program that consists only of the exercises they are taught during their physiotherapy sessions. The exercise sheet given at week 6 replaces the previous sheet. It incorporates most of the exercises already performed as part of the home exercise program during weeks 2-6 but progresses these so they are no-longer group specific.
Specific exercises detailed on the exercise sheet include:
1): scapular setting through progressive range of motion;
2) rotator cuff internal/external rotation with elastic resistance band
3): posterior muscle strengthening - (i) standing rows with resistance band as tolerated at 45, 90 and 120 degrees; single bent forward row with elastic resistance band as tolerated.
4): flexibility exercises: (i) thoracic mobility in sitting, (ii) thoracic mobility in lie over rolled towel; (iii) anterior shoulder stretch (pectorals in door jamb);

At week 9, they will attend a check-review to ensure compliance with the exercise sheet.

The assessment and treatment sessions will be carried out by a designated musculoskeletal Physiotherapist at each site, with at least 5 years experience. Prior to recruitment of participants into the study, all clinicians involved in assessment and treatment delivery will receive training in the techniques to be used in each group, as per the study protocol. All treatment interventions will be recorded on standardised report forms. The treatment sessions will be individual 1: 1 sessions lasting up to 30 minutes per session
Control group
Active

Outcomes
Primary outcome [1] 299429 0
determine feasibility of a full-scale randomized controlled trial.
Timepoint [1] 299429 0
weeks 6 and 12
Secondary outcome [1] 328609 0
Perception of pain (current/usual/night) using 11 point numerical rating scale (NRS)
Timepoint [1] 328609 0
Baseline
Within-treatment during rotator cuff strengthening intervention (weeks 3 and 4)
Week 6
Week 12
Secondary outcome [2] 329228 0
Shoulder muscle strength (using hand held dynanometer).
Timepoint [2] 329228 0
Baseline
Within-treatment during rotator cuff strengthening intervention (weeks 3 and 4)
Week 6
Week 12
Secondary outcome [3] 329230 0
Western Ontario Rotator Cuff Index (WORC)
Timepoint [3] 329230 0
Baseline
Week 6
Week 12
6 months
Secondary outcome [4] 329231 0
Shoulder Pain and Disability Index (SPADI)
Timepoint [4] 329231 0
Baseline
Week 6
Week 12
6 months
Secondary outcome [5] 329232 0
Perceived global rating of change score (GRCS)
Timepoint [5] 329232 0
Week 12

Eligibility
Key inclusion criteria
Aged 18-80 years (likelihood of patients > 80 of having degenerative changes in the shoulder is increased)
Pain localised to the proximal anterolateral shoulder region
Since no single impingement test has shown high specificity, clinical history plus a cluster of 2 or more tests from the following is recommended to identify patients with SPS:
Pain on elevation (abduction/flexion/scaption) and/or a painful arc in elevation
Positive impingement test (Hawkins-Kennedy and/or Neer’s test)
Pain on isometric abduction (positive full can or empty can)
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
large, full thickness rotator cuff tear
Moderate-severe glenohumeral joint (GHJ) or acromioclavicular joint (ACJ) Osteoarthritis
GHJ instability including previous shoulder dislocation/subluxation
Previous shoulder fracture
Current neck pain/dysfunction with a somatic or radicular referral pattern indicative of cervical spine > shoulder primary source of symptom and/or pathology
Neurological deficits of the upper limb
Systemic inflammatory arthritic conditions

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)
In order to minimise bias: patients will not be told which intervention group they have been randomised to. All data will be de-identified and data analysis will be performed with group allocation undisclosed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Since there could be a difference in baseline demographics in participants recruited in the public and private sectors, block randomisation will be used to ensure that participants from each of the three clinics have an equal chance of receiving any of the interventions. Once consented, participants will be randomly allocated using an off-site randomiser and computer generated allocation sequence to one of three groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary outcome of this study is to determine feasibility of a full-scale RCT. Feasibility will be evaluated by assessing the ease of recruiting participants (number and rate), adherence to the intervention (home-exercise program and log-book recording), non-completion (drop-out number and rate) and, adverse events.

Comparison of between-group changes in secondary outcomes at each of the follow up time-points will be used to determine treatment efficacy.Data will be analysed on intention to treat principles for all participants using SPSS statistical packages (Version 24, SPSS Inc. Chicago, IL) and significance set at p<0.5.
Baseline between-group participant characteristics will be evaluated and included in covariate/regression analysis if deemed to have a potential influence on outcomes.




Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
COVID-19 restrictions on research meant recruitment was stopped early.
Date of first participant enrolment
Anticipated
19/12/2016
Actual
28/06/2017
Date of last participant enrolment
Anticipated
22/03/2020
Actual
21/01/2020
Date of last data collection
Anticipated
6/09/2020
Actual
14/08/2020
Sample size
Target
36
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6548 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 14136 0
3065 - Fitzroy
Recruitment postcode(s) [2] 18734 0
3068 - Clifton Hill
Recruitment postcode(s) [3] 18735 0
3752 - South Morang

Funding & Sponsors
Funding source category [1] 294391 0
Hospital
Name [1] 294391 0
St Vincent's Hospital, Melbourne
Country [1] 294391 0
Australia
Funding source category [2] 294962 0
Charities/Societies/Foundations
Name [2] 294962 0
Arthritis Foundation of Australia
Country [2] 294962 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, Melbourne, VIC, 3065
Country
Australia
Secondary sponsor category [1] 293238 0
University
Name [1] 293238 0
La Trobe University
Address [1] 293238 0
La Trobe Sport and Exercise Medicine Research Centre,
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Corner of Kingsbury Drive and Plenty Rd
Melbourne (Bundoora), VIC 3086
Country [1] 293238 0
Australia
Other collaborator category [1] 279179 0
Commercial sector/Industry
Name [1] 279179 0
Mill Park Physiotherapy Centre
Address [1] 279179 0
22/1 Danaher Drive, South Morang, Melbourne, VIC 3752
Country [1] 279179 0
Australia
Other collaborator category [2] 279314 0
Commercial sector/Industry
Name [2] 279314 0
Clifton Hill Physiotherapy Clinic
Address [2] 279314 0
111 Queens Parade, Clifton Hill, Melbourne, VIC 3068
Country [2] 279314 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295812 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 295812 0
Ethics committee country [1] 295812 0
Australia
Date submitted for ethics approval [1] 295812 0
25/07/2016
Approval date [1] 295812 0
18/11/2016
Ethics approval number [1] 295812 0
LNR/16/SVHM/169
Ethics committee name [2] 295813 0
Faculty of Human Ethics Committee Faculty of Health Sciences, Latrobe University, Melbourne
Ethics committee address [2] 295813 0
Ethics committee country [2] 295813 0
Australia
Date submitted for ethics approval [2] 295813 0
20/11/2016
Approval date [2] 295813 0
Ethics approval number [2] 295813 0

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

Contacts
Principal investigator
Name 67930 0
Ms Rita Kinsella
Address 67930 0
Physiotherapy Department
St Vincent's (Public) Hospital
41 Victoria Parade
Melbourne VIC 3065
Country 67930 0
Australia
Phone 67930 0
+61 451 090 729
Fax 67930 0
Email 67930 0
[email protected]
Contact person for public queries
Name 67931 0
Rita Kinsella
Address 67931 0
Physiotherapy Department
St Vincent's (Public) Hospital
41 Victoria Parade
Melbourne VIC 3065
Country 67931 0
Australia
Phone 67931 0
+61 451 090 729
Fax 67931 0
Email 67931 0
[email protected]
Contact person for scientific queries
Name 67932 0
Rita Kinsella
Address 67932 0
Physiotherapy Department
St Vincent's (Public) Hospital
41 Victoria Parade
Melbourne VIC 3065
Country 67932 0
Australia
Phone 67932 0
+61 451 090 729
Fax 67932 0
Email 67932 0
[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?
De-identified individual participant clinical data that underlies published results.
When will data be available (start and end dates)?
From 1-7 years following publication of the study results
Available to whom?
Other researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of the PI, on request.
Available for what types of analyses?
For the purposes of systematic reviews and meta-analysis.
How or where can data be obtained?
Data can be obtained via the Principle Investigator (Rita Kinsella) via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6712Study protocolKinsella R, Cowan S, Watson L, Pizzari T. A comparison of isometric, isotonic concentric and isotonic eccentric exercises in the physiotherapy management of subacromial pain syndrome/rotator cuff tendinopathy: study protocol for a pilot randomised controlled trial. Pilot and Feasibility Studies. 2017 Nov 14;3:45. doi: 10.1186/s40814-017-0190-3.   



Results publications and other study-related documents

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