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Trial registered on ANZCTR


Registration number
ACTRN12613001240730
Ethics application status
Approved
Date submitted
7/11/2013
Date registered
12/11/2013
Date last updated
16/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Exercise Based Management on Multidirectional Instability of the Glenohumeral Joint: A Pilot Randomised Controlled Trial.
Scientific title
The effect of two different exercise programs on scapula, strength and function measures of participants with clinically diagnosed Multidirectional Instability of the glenohumeral joint.
Secondary ID [1] 283530 0
Nil
Universal Trial Number (UTN)
U1111-1148-9049
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multidirectional Instability (MDI) of the Glenohumeral Joint 290446 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290837 290837 0 0
Physiotherapy
Musculoskeletal 290868 290868 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 physiotherapy sessions (one 60 minute session and eleven 30 minute session one to one) delivering the Lyn Watson MDI Program. This rehabilitation program is primarily based around maintaining good scapula and humeral head control through 6 stages. Assessment of the effect of manual correction determines the position of scapula and/or humeral head control that improves a patient’s objective asterisk(s). This position is then adopted in a ‘setting’ action whist performing drills in the relevant stages.
Exercises are performed with theraband or weights for resistance. An outline of the 6 stages of the Lyn Watson protocol is as follows:


Stage 1- Coronel Plane Strengthening 0 to 45 degrees Abduction:
Scapula upward rotation and tilting
Internal Rotation/External Rotation from 0 to 45 abduction with theraband
Standing/bent over rows 0 to 45 degrees abduction

Stage 2- Building Posterior Musculature
Bent over rows
Side lie external rotation
Standing rows

Stage 3: Flexion Drills
Flexion Drills from 0 to 45 degrees Abduction

Stage 4: Coronal Plane Strengthening 45 to 90 degrees Abduction
Internal Rotation/External Rotation from 45 to 90 degrees abduction with theraband
Standing/bent over rows 0 to 45 degrees abduction
Flexion to 90 degrees abduction

Stage 5: Specific Strength Drills
Bent over rows (Posterior deltoid)
Supine and sitting flexion (Anterior deltoid)
Lateral Raises (Middle deltoid)

Stage 6: Sports Specific and Functional Specific Drills
Drills determined by the requirements of the patient.
Load and progressed to allow for return to sport or function.


Each week will be used to review, prescribe and progress the exercise program. A trained trial physiotherapist will deliver the program and compliance will be monitored by exercise log sheets.

Each participant will be asked to perform his or her prescribed exercise program at home (home exercise program). This will involve the participant performing 3 to 7 exercises with the use of therabands and weights, which will be provided to the participant as part of the trial. The exercise program will take between 15 and 20 minutes to complete and will be performed two to three times a day; to once every two days, depending on the phase of the program. At the beginning of the program, the exercises will focus more on recruitment of muscle (exercises performed two to three times a day) and later in the program the exercises may focus more on muscle strength (exercises performed once every second day).


At the end of the 12 week program and after the 12 week outcome measures have been taken, participants who score less than a minimal detectable change on both primary outcome measures have the option to cross over into the alternative treatment arm for a subsequent 12 weeks.

Intervention code [1] 288229 0
Rehabilitation
Intervention code [2] 288230 0
Treatment: Other
Comparator / control treatment
12 physiotherapy sessions (one 60 minute session and eleven 30 minute session one to one) delivering the Rockwood Instability Program. Each week will be used to review, prescribe and progress the exercise program. The program focuses on concurrently strengthening all three parts of the deltoid, the internal and external rotators of the glenohumeral joint and scapula stabilizing muscles, in two phases.

The exercises for each phase remain the same and are as follows:
Standing external rotation
Standing internal rotation
Standing punch
Standing row
Abduction to 45 degrees
Wall, knee and full push ups

Phase 1: involves the above exercise with increasing resistances of theraband: 0.5kg (tan 50 % elongation), 1.0kg (tan), 1.5kg (yellow), 2.0kg(red), 2.5kg(green) and 3kg (blue).

Phase 2: Once the participant has progressed to the blue band then the participant performs the same exercises with a weight and pulley system commencing with a load of 4-5 kg and working in 1kg increments to 7kg (female) or 11 kg (male).

A trained trial physiotherapist will deliver the program and compliance will be monitored by exercise log sheets.


Each participant will be asked to perform his or her prescribed exercise program at home (home exercise program). This will involve the participant performing 3 to 7 exercises with the use of therabands and weights, which will be provided to the participant as part of the trial. The exercise program will take between 15 and 20 minutes to complete and will be performed two times a day throughout the entire 12 week program.


At the end of the 12 week program and after the 12 week outcome measures have been taken, participants who score less than a minimal detectable change on both primary outcome measures have the option to cross over into the alternative treatment arm for a subsequent 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 290836 0
The Melbourne Instability Shoulder Index (MISS)
Timepoint [1] 290836 0
Baseline, 6,12, 24 and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Primary outcome [2] 290837 0
The Western Ontario Shoulder Instability Index (WOSI).
Timepoint [2] 290837 0
Baseline, 6,12, 24 and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [1] 305394 0
Scapula co ordinates (in centimetres from the y axis of the centre of the spine to the x axis of the inferior scapula angle, medial scapula angle and lateral scapula angle) at rest, 90 degrees and end range of motion abduction will be measured bilaterally with a tape measure.
Timepoint [1] 305394 0
Baseline and 12 weeks post randomisation.
Secondary outcome [2] 305395 0
Scapula angles. Angle of scapula upward rotation at rest 30,45,60,90,120,135 degrees and end range of motion abduction will be measured bilaterally with an inclinometer on the superior scapula spine.

Timepoint [2] 305395 0
Baseline and 12 weeks post randomisation
Secondary outcome [3] 305396 0
Strength measures. Strength will be measured bilaterally with a handheld dynamometer. Measures of strength will include: external rotation 0 degrees abduction, internal rotation 0 degrees abduction,extension, abduction, flexion (supine), external rotation at 90 degrees abduction, internal rotation at 90 degrees abduction, empty can test, speeds test , press belly test, shrug test (resisted scapula upward rotation/elevation)
Timepoint [3] 305396 0
Baseline and 12 weeks post randomisation.
Secondary outcome [4] 305397 0
Symptomatic onset range in active abduction.
The angle of abduction where the patient first reports their symptom onset on the affected arm (p1/r1, guarding) measured in degrees with an inclinometer.
Timepoint [4] 305397 0
Baseline and 12 weeks post randomisation.
Secondary outcome [5] 305398 0
Limiting angle in active abduction. The angle at which the participant reaches their abduction limit on the affected arm measured in degrees with an inclinometer.

Timepoint [5] 305398 0
Baseline and 12 weeks post randomisation.
Secondary outcome [6] 305399 0
Reported Reason for limiting angle. The patient reported reason for the limit in abduction range on the affected arm.
Timepoint [6] 305399 0
Baseline and 12 weeks post randomisation.
Secondary outcome [7] 305405 0
Patient satisfaction (of treatment and outcome)
Patient satisfaction with treatment and results will be measured with a categorical scale. The categories will be as follows: very dissatisfied, somewhat dissatisfied, neither satissifed or dissatisfied, somewhat satisfied, very satisfied.

This scale will be marked by the participant in their follow up outcome booklet.
Timepoint [7] 305405 0
6,12, 24 and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [8] 305406 0
Global Rating of Change (7 point global rating of change scale)
Timepoint [8] 305406 0
Timepoint: 6,12, 24 and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [9] 305407 0
Incidence of Dislocation. Reported number of full dislocations (if any).
Timepoint [9] 305407 0
6,12, 24 and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [10] 305408 0
Orebro Musculoskeletal Pain Questionnaire
Timepoint [10] 305408 0
Baseline, 6 weeks,12 weeks, 24 weeks and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [11] 305409 0
Adverse Events. Adverse events will be measured.

Adverse events will be assessed by the trial physiotherapist with closed and open ended questions in every treatment session. Questions included will be:
"Have you had any pain associated with the exercise program? If yes, please decribe."
Have you had any pain or increase in pain NOT associated with the exercise program? If yes, please decribe."

Examples of adverse events include: pain increase attributed to the home exercise program, episode of shoulder subluxation attributed to the home program, any other injury attributed to the home exercise program (i.e: back injury).
Timepoint [11] 305409 0
Recorded in the clinical notes for every session and formally assessed at 6 weeks,12 weeks, 24 weeks and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [12] 305410 0
Medications. Medications taken by the participant will be recorded.
Timepoint [12] 305410 0
Baseline, 6 weeks,12 weeks, 24 weeks and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [13] 305411 0
Co- interventions. Co –interventions will be recorded.

Examples of Co- interventions include: taping or massage administered as a method of pain control during the physiotherapy session in conjunction with exercise prescription, any other co interventions delivered by other medical practitioners( from general practitioners, sports doctors) during the trial period.
Timepoint [13] 305411 0
6 weeks,12 weeks, 24 weeks and 52 weeks post randomisation. For participants who cross over into the other intervention arm after 12 weeks, outcome measures will also be taken at 18 weeks post randomisation (6 weeks post cross over).
Secondary outcome [14] 305412 0
Compliance. Compliance with both exercise programs will be recorded.

Timepoint [14] 305412 0
Timepoint: At weekly time points after the commencement of both interventions and at weekly timepoints for participants who cross over into the other intervention arm after 12 weeks.
Secondary outcome [15] 305413 0
Assessment of Success of Blinding. Success of blinding of participants to what treatment arm they received will be assed will the following question:
“ This trial compared the effect of two exercise programs, a new program and an established program. Where you aware of which exercise program you received? “
The participant can tick one of 3 options:
YES
NO
UNSURE.
If yes, which program do you think you received?
Why?
Timepoint [15] 305413 0
12 weeks post randomisation

Eligibility
Key inclusion criteria
Diagnosis of MDI (Instability in at least 2 directions).
No significant history of trauma
Willingness to participate in a 12 week exercise program
Aged between 12 and 35 years inclusive.
No bony or labral lesion detected on Magnetic Resonance Imaging (MRI) scan.
Minimum age
12 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of significant trauma
Bony or labral lesion detected on MRI
Prior surgical history of the affected shoulder (s)
Non correctable volitional instability
Ehler-Danlos Syndrom/Marfan’s Syndrome
Shoulder pain that is predominantly due to cervical pain

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)
Volunteers who respond to advertising, or who are referred by a medical practitioner or health care professional, will undergo a phone screening
and baseline physical assessment to determine eligibility by a trial assessor. Eligible volunteers who consent to participate will complete baseline outcome measures prior to being randomised to the Lyn Watson MDI or Rockwood Instability Program.

Randomisation will be done by the contacting an off-site trial administrator who will hold the randomisation schedule, and will not be involved in assessing, enrolling or treating participants.

A researcher at La Trobe University who will have no contact with
participants will generate a randomisation schedule prior to trial commencement. The randomization sequence will be generated using a web based randomization program (http://www.randomisation.com) and will be stratified for treating practitioner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation sequence (random block lengths) will be generated with a web-based randomisation program, with stratification for treating practitioner.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Parallel/Crossover.
Two different groups of participants with MDI will receive two different exercise programs for a duration of 12 weeks. At the end of the 12 weeks, and after the 12 week outcome measures have been assessed, participants who score less than a minimal detectable change on both primary outcome measures have the option to cross over to the alternative intervention arm for a subsequent 12 weeks.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be analysed on intention to treat principles (primary method) and on a per protocol basis. Data Analysed will focus on detecting the between group treatment and within group treatment effects (with effect sizes and 95 % confidence intervals) at each of the follow up time points. Primary analyses for the MISS, the WOSI, scapula co-ordinates, scapula angles, strength, angle of symptom onset in abduction, limiting angle in abduction and the Orebro will be performed using linear mixed models. If the data is inappropriate for the use of a linear mixed models, a repeated measures ANCOVA will be used. Global rating of change and satisfaction scores will be measured with Mann Whitney U tests. Reason for limit in abduction and incidence of dislocation will be analysed with chi square tests. Adverse events, medications taken, co-interventions, compliance with the exercise program and success of blinding will be recorded.

If the primary efficacy analysis reveals statistical significance between groups on a primary outcome measure, a responder analyses will be conducted to detect the clinical importance between groups. This will be achieved by dichotomizing individual participants as either “responders” or “non responders” based on whether they improved from baseline by more than the MCID on the MISS (5 points) and/or the WOSI (10.4%). The difference between the proportions of participants who experience an improvement greater than the MCID in the two groups will then be analysed with risk ratios, risk differences and numbers needed to treat.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/11/2013
Actual
Date of last participant enrolment
Anticipated
30/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
328
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288226 0
Commercial sector/Industry
Name [1] 288226 0
Health Networks Australia / LifeCare Health
Country [1] 288226 0
Australia
Funding source category [2] 288227 0
Commercial sector/Industry
Name [2] 288227 0
Imaging @ Olympic Park Sports Medicine
Country [2] 288227 0
Australia
Funding source category [3] 288228 0
University
Name [3] 288228 0
La Trobe University, Bundoora Melbourne
Country [3] 288228 0
Australia
Funding source category [4] 288229 0
Commercial sector/Industry
Name [4] 288229 0
Sports Medicine Australia (SMA)
Country [4] 288229 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Health Networks Australia / LifeCare Health
Address
Level 1, 416 High Street Kew VIC 3101
Country
Australia
Secondary sponsor category [1] 286949 0
University
Name [1] 286949 0
La Trobe University, Bundoora Melbourne
Address [1] 286949 0
School of Physiotherapy Faculty of Health Sciences
Corner Kingsbury Drive and Plenty road Bundoora 3086
Country [1] 286949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290135 0
Faculty of Human Ethics Committee Faculty of Health Sciences, Latrobe University, Melbourne
Ethics committee address [1] 290135 0
Ethics committee country [1] 290135 0
Australia
Date submitted for ethics approval [1] 290135 0
Approval date [1] 290135 0
15/04/2013
Ethics approval number [1] 290135 0
FHEC12/201

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

Contacts
Principal investigator
Name 44122 0
Miss Sarah Ann Warby
Address 44122 0
Department of Physiotherapy
School of Allied Health/Faculty of Health Sciences
Health Sciences 3 (HS3) Level 5
Latrobe University
Corner of Kingsbury Drive and Plenty Rd
Bundoora VIC 3083




Country 44122 0
Australia
Phone 44122 0
+61 478 405 258
Fax 44122 0
+61 3 9479 5768
Email 44122 0
sarahannwarby@gmail.com
Contact person for public queries
Name 44123 0
Sarah Ann Warby
Address 44123 0
Department of Physiotherapy
School of Allied Health/Faculty of Health Sciences
Health Sciences 3 (HS3) Level 5
Latrobe University
Corner of Kingsbury Drive and Plenty Rd
Bundoora VIC 3083
Country 44123 0
Australia
Phone 44123 0
+61 478 405 258
Fax 44123 0
+61 3 9479 5768
Email 44123 0
sarahannwarby@gmail.com
Contact person for scientific queries
Name 44124 0
Sarah Ann Warby
Address 44124 0
Department of Physiotherapy
School of Allied Health/Faculty of Health Sciences
Health Sciences 3 (HS3) Level 5
Latrobe University
Corner of Kingsbury Drive and Plenty Rd
Bundoora VIC 3083
Country 44124 0
Australia
Phone 44124 0
+61 478 405 258
Fax 44124 0
+61 3 9479 5768
Email 44124 0
sarahannwarby@gmail.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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