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Trial registered on ANZCTR


Registration number
ACTRN12618000845235
Ethics application status
Approved
Date submitted
15/05/2018
Date registered
21/05/2018
Date last updated
24/04/2020
Date data sharing statement initially provided
29/04/2019
Date results information initially provided
24/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of manual therapy interventions of the upper back in addressing shoulder impingement syndrome in people over 40 years old.
Scientific title
A comparison of 3 manual therapy treatments of the thoracic spine in people over 40 years of age, suffering shoulder impingement syndrome, with outcome measures being potential improvement in thoracic posture and range of motion and potential improvement in shoulder pain and disability.
Secondary ID [1] 294859 0
Nil known
Universal Trial Number (UTN)
U1111-1214-0412
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder impingement syndrome 307835 0
Condition category
Condition code
Musculoskeletal 306880 306880 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All intervention is a form of manual therapy performed by an experienced and registered osteopath to participants randomly allocated to one of 3 groups.
Arm 1: Sham treatment.
Arm 2: Manual therapy to the thoracic spine only. Muscle energy technique (MET) and joint mobilisation will be the only techniques used to the thoracic spine. These techniques are very commonly used osteopathic manual therapy techniques. Both techniques are used in an attempt to increase the range of motion of a joint, in this case, the thoracic spine. Joint mobilisation involves moving one bone of a joint, in this case a vertebrae, with respect to another bone in a joint, another adjacent vertebrae. The movement is small. MET uses joint mobilisation, but once one vertebrae has been moved with respect to another, the practitioner asks the participant to then gently push (contract the appropriate muscles) a body part (for the upper thoracics, the head is usuaully the lever, while for the lower thoracis, the lever can be the trunk or legs) against resistance applied by the practitioner (hence, an isometric contraction) to re-approximate the bones. The practitioner asks for this muscle contraction for between 2 to 5 seconds, then the participant relaxes, at which time the practitioner attempts to increase again the joint range of motion. This can be repeated from 2 to 5 times. All movements by the practitioner are very small and gentle and all muscle contractions by the participant are also gentle. In both joint mobilisation and MET the vertebrae are returned to their original position.
Arm3: Manual therapy to the thoracic spine and soft tissue to the rotator cuff. These participants will receive the same treatment as Arm 2 plus soft tissue (massage) techniques to the rotator cuff and posterior scapula muscles of the affected shoulder. The soft tissue techniques will include inhibition, effleurage and cross fibre techniques.
In Arm 2 and Arm 3 every technique listed above will be used but it will be up to the practitioner as to how much of each technique will be used. The same registered osteopathic practitioner will be doing every intervention.
All interventions will be performed face to face by an experienced and registered osteopath in an established osteopathic clinic. Once participants are deemed eligible, they will be booked in for one intervention session per week for 4 weeks. Participants must attend the first and last session, but the second and third sessions are their choice. They will receive the same intervention each time. Each intervention will take approximately 20-30 minutes. There are no strategies to monitor adherence to the intervention except to book them in to all 4 sessions at their first attendance.
Intervention code [1] 301201 0
Treatment: Other
Comparator / control treatment
Arm 1 is the control group. This group will receive an active intervention. This intervention will be a de-tuned laser. That is a laser that appears to be working, as all lights and noises (if applicable) will be working, but the laser itself will not. The de-tuned laser is a sham treatment and has no therapeutic effect. The de-tuned laser will be applied to the participant's thoracic spine and posterior scapula muscles of the affected shoulder. The participant will be face-down on an osteopathic bench the entire intervention. The intervention will take approximately 20 minutes.
Control group
Active

Outcomes
Primary outcome [1] 305882 0
DASH (Disabilities of the arm shoulder and hand) - most used and validated shoulder questionnaire.
Timepoint [1] 305882 0
After the final intervention - week 4 (primary timepoint).
Secondary outcome [1] 346874 0
2 measures of thoracic posture:
a) thoracic posture - measured with the participant in a relaxed standing position using inclinometers.
b) thoracic range of motion - measured using an inclinometer. The first reading will be measuring the degree of kyphosis with the participant seated, fully bending forward. The second measurement will be measuring the degree of extension of the thoracic spine with the participant arching backwards from a seated position.
This is a composite outcome measure given thoracic range of motion is directly related to thoracic posture.
Timepoint [1] 346874 0
First measurement is at baseline, before the first intervention. These measurements will be performed again immediately after the first intervention.
These measurements will then be repeated then immediately before and after the last intervention (week 4).
Secondary outcome [2] 346935 0
SPADI - shoulder pain and disability index.
This is a questionnaire for shoulder pain and disability
Timepoint [2] 346935 0
Baseline
After the final intervention (at 4 weeks)
At all the follow-up time points - 4 weeks after the final intervention, 6 months and 12 months
Secondary outcome [3] 346946 0
Patient-Specific Functional Scale diagram - validated questionnaire for patient chosen activities related to using their shoulder.
Timepoint [3] 346946 0
These are filled in at every time point: Baseline before the first intervention); then at the second, third and fourth interventions - immediately after each of these interventions.

At all the follow-up time points - 4 weeks after the final intervention, 6 months and 12 months after the final intervention.
Secondary outcome [4] 346948 0
Visual analogue scale (VAS) - 4 week recall - represents the average amount of shoulder pain over the last 4 week period.
Timepoint [4] 346948 0
At:
baseline
after the last intervention (at 4 weeks)
At all follow-up time points - 4 weeks after the last intervention, 6 months and 12 months
Secondary outcome [5] 346949 0
Global Rating of Change (GROC) diagram - validated questionnaire describing if a participants condition has improved or not
Timepoint [5] 346949 0
After the final intervention (4 weeks)
At all the follow-up time points - 4 weeks post intervention, 6 months and 12 months after the last intervention.
Secondary outcome [6] 347005 0
Visual analogue scale (VAS) - current pain - represents the current amount of shoulder pain being experienced.
Timepoint [6] 347005 0
These are filled in at every time point: Baseline before the first intervention); then at the second, third and fourth interventions - immediately after each of these interventions.

At all the follow-up time points - 4 weeks after the final intervention, 6 months and 12 months after the final intervention.
Secondary outcome [7] 347006 0
Visual analogue scale (VAS) - 7 day recall. - represents the average amount of shoulder pain over the last 7 day period.
Timepoint [7] 347006 0
These are filled in at every time point: Baseline before the first intervention); then at the second, third and fourth interventions - immediately after each of these interventions.

At all the follow-up time points - 4 weeks after the final intervention, 6 months and 12 months after the final intervention.

Eligibility
Key inclusion criteria
Participants must be between 40 and 80 years of age and have experienced at least 3 episodes of shoulder pain per week over the last 3 months that is suspected to be shoulder impingement syndrome.
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent treatment to a participant's shoulder back of neck by a physiotherapist, osteopath or chiropractor. Previous traumatic injuries to the shoulder, neck or back including fractures or dislocations. Any surgeries of the shoulder back or neck. Any known malignancies, inflammatory diseases, infectious diseases or neurological diseases of the shoulder, back or neck.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Using stata statistical package the sample size for a two-sample paired means test was performed. A clinically important difference for the DASH questionnaire (our primary outcome) is considered to be 10.2 (established in scientific literature). A previous study by this researcher established a mean score of 61.9 using the DASH for people suffering shoulder impingement syndrome. Hence it was determined 19 participants would be required for each group to achieve a power of 80% and 5% level of significance. To increase the power each group will have 25 participants.
Once data has been collected a one-way ANOVA with Bonferroni post-hoc tests will be used to compare differences between pairs of groups. Paired t-tests will be used to analyse changes within each group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299448 0
University
Name [1] 299448 0
University of Newcastle
Address [1] 299448 0
University of Newcastle
University Drive
Callaghan
NSW 2308
Country [1] 299448 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 298743 0
None
Name [1] 298743 0
Address [1] 298743 0
Country [1] 298743 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300354 0
Human Research Ethics Committee
Ethics committee address [1] 300354 0
Human Research Ethics Committee
University of Newcastle
University Drive
Callaghan
NSW 2308
Australia
Ethics committee country [1] 300354 0
Australia
Date submitted for ethics approval [1] 300354 0
15/03/2018
Approval date [1] 300354 0
30/04/2018
Ethics approval number [1] 300354 0
H-2018-0110

Summary
Brief summary
The aim of this RCT is to assess whether interventions addressing the thoracic spine are effective in reducing shoulder impingement pain. Participants with shoulder impingement pain will be randomised to receive one of: sham treatment, manual therapy to the thoracic spine, or manual therapy to the thoracic spine and shoulder treatments. All treatments will be delivered by a registered osteopath using pragmatic standard osteopathic manual therapy techniques. Outcome measures will be shoulder pain and disability questionnaires, visual analogue scales ,global rating of change diagram, patient-specific function scale diagram, and thoracic posture measure and thoracic range of motion measured with an inclinometer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83374 0
Mr Donald Hunter
Address 83374 0
Donald Hunter
University of Newcastle
PO Box 559
The Junction
NSW 2291
Country 83374 0
Australia
Phone 83374 0
+61 2 49655125
Fax 83374 0
+61 2 49525378
Email 83374 0
donald.hunter@uon.edu.au
Contact person for public queries
Name 83375 0
Mr Donald Hunter
Address 83375 0
Donald Hunter
University of Newcastle
PO Box 559
The Junction
NSW 2291
Country 83375 0
Australia
Phone 83375 0
+61 2 49655125
Fax 83375 0
+61 2 49523578
Email 83375 0
donald.hunter@uon.edu.au
Contact person for scientific queries
Name 83376 0
Mr Donald Hunter
Address 83376 0
Donald Hunter
University of Newcastle
PO Box 559
The Junction
NSW 2291
Country 83376 0
Australia
Phone 83376 0
+61 2 49655125
Fax 83376 0
+61 2 49525378
Email 83376 0
donald.hunter@uon.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As approved by ethics
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary