Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001303538
Ethics application status
Approved
Date submitted
24/11/2015
Date registered
30/11/2015
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Specific Physiotherapy Management for Subacromial Impingement
Scientific title
Prospective randomised double blinded control trial to compare the effect of three evidence based physiotherapy treatments (mobilisation of thoracic spine versus posterior shoulder treatment versus ultrasound) on shoulder and thoracic range of motion, pain and function in adults with subacromial impingement.
Secondary ID [1] 287267 0
Nil Known
Universal Trial Number (UTN)
U1111-1176-8981
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial Shoulder Impingement 296856 0
Condition category
Condition code
Musculoskeletal 297090 297090 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297107 297107 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy treatment provided for six consecutive weeks. Twice a week for three weeks followed by once a week for three weeks.
Intervention One is mobilisation of thoracic spine in prone position which consists of transverse mobilisations from the direction of painful side to non-painful side and costovertebral mobilisation on the painful side at thoracic levels 1 to 6. Time taken = 20 minutes..A home exercise of lying on rolled towel positioned longitudinally along thoracic spine for 5 mins, twice a day - to be continued on a daily basis for the full twelve weeks of the study.
Intervention two is release of posterior shoulder tightness using massage to the posterior soft tissues and AP mobilisation of painful glenohumeral joint. Time taken = 20 minutes. A home programme of passive cross adduction stretch in standing, performed twice for the count of 20, two times during the day - to be continued on a daily basis for the full twelve weeks of the study
The home programme is monitored via exercise diary provided to the subjects.
Intervention code [1] 293320 0
Treatment: Other
Intervention code [2] 293334 0
Rehabilitation
Comparator / control treatment
Ultrasound is being used as the control. Previous studies using ultrasound have shown there is no benefit in the treatment of shoulder impingement but ultrasound is considered a standard physiotherapy treatment.
Ultrasound is applied at 1MHz 50% Pulsed 0,5wcm(squared) for 5 mins to the subacromial area. This treatment is administered for six consecutive weeks being twice a weeks for three weeks followed by once a week for three weeks.
Control group
Active

Outcomes
Primary outcome [1] 296695 0
Change in range of thoracic motion. Sagittal plane digital photographs are taken and software used to measure the change in thoracic angles from these photographs.
Timepoint [1] 296695 0
Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.
Primary outcome [2] 296696 0
Numeric Rating Scale for level of shoulder pain. 0 = no pain and 10 being the worst pain imaginable.
Timepoint [2] 296696 0
Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.
Primary outcome [3] 296697 0
SPADI outcome measure (Shoulder Pain and Disability Index).
Timepoint [3] 296697 0
Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.
Secondary outcome [1] 319138 0
Painful shoulder range of motion using standard plastic goniometer by the one principal investigator.
Timepoint [1] 319138 0
Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.

Eligibility
Key inclusion criteria
Minimum of three positive orthopaedic special tests. Hawkins- Kennedy and/or Neer must be positive along with two of the following: Painful Arc, Speed, Cross Body Adduction, External Rotation Resistance Test and pain on tendon palpation.
Catching’ or aching pain without appreciable joint stiffness.
Pain localized to the anterior or antero-lateral-superior shoulder.
Insidious onset of symptoms with a possible history of gradual progression over time but without history of trauma.
Minimum age
40 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previously undergone shoulder surgery or suffered a fracture of the shoulder girdle
Presence of scoliosis or current cervical or thoracic signs or symptoms,
Glenohumeral instability by eliciting a grade 2 or 3 in an anterior, posterior or inferior load and shift test or have had a previous shoulder dislocation.
A diagnosed systemic or neurological disease.
The identification of osteophytes within the subacromial space; calcification of tendons or large rotator cuff tears on imaging

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)
Allocation performed by administration officer at separate location to principal investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Three sample size calculations were estimated using 1.passive range of internal shoulder rotation (mean difference of 18 degrees and SD 14 degrees); 2. numeric rating scale (mean difference of 5 SD 2); 3. SPADI total score (mean score 30 SD 20). The maximum number of participants needed was calculated as 60 (20 in each group) to produce a power of 0.9 and alpha = 0.05 (level of significance. This sample size allows assumption of normal distribution and the use of independent t-tests and ANOVA for analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
30/09/2016
Actual
16/09/2016
Date of last data collection
Anticipated
29/11/2016
Actual
9/12/2016
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12283 0
4810 - Townsville

Funding & Sponsors
Funding source category [1] 292447 0
University
Name [1] 292447 0
James Cook University
Country [1] 292447 0
Australia
Primary sponsor type
Individual
Name
Helen Land
Address
Helen Land
PhD Candidate
James Cook University
Discipline of Physiotherapy
JCU Physiotherapy Clinic
Building 500. 1 James Cook Drive
James Cook University
Douglas 4811 Queensland
Country
Australia
Secondary sponsor category [1] 291143 0
Individual
Name [1] 291143 0
Dr Susan Gordon
Address [1] 291143 0
Professor Susan Gordon PhD Supervisor School Of Health Sciences, Flinders University 17 Rockville Avenue Daw Park 5041 South Australia
Country [1] 291143 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293908 0
James Cook University Human Ethics Committee
Ethics committee address [1] 293908 0
Ethics committee country [1] 293908 0
Australia
Date submitted for ethics approval [1] 293908 0
18/05/2015
Approval date [1] 293908 0
02/07/2015
Ethics approval number [1] 293908 0
H6129

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 645 645 0 0
/AnzctrAttachments/369106-Approval Form H6129 Land.pdf (Other)
Attachments [2] 2161 2161 0 0
/AnzctrAttachments/369106-SIGNED REPORT.pdf (Other)

Contacts
Principal investigator
Name 59482 0
Mrs Helen Land
Address 59482 0
JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland
Country 59482 0
Australia
Phone 59482 0
+61747815840
Fax 59482 0
+61747792739
Email 59482 0
[email protected]
Contact person for public queries
Name 59483 0
Helen Land
Address 59483 0
JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland
Country 59483 0
Australia
Phone 59483 0
+61747815840
Fax 59483 0
+61747792739
Email 59483 0
[email protected]
Contact person for scientific queries
Name 59484 0
Helen Land
Address 59484 0
JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland
Country 59484 0
Australia
Phone 59484 0
+61747815840
Fax 59484 0
+61747792739
Email 59484 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEffect of manual physiotherapy in homogeneous individuals with subacromial shoulder impingement: A randomized controlled trial.2019https://dx.doi.org/10.1002/pri.1768
N.B. These documents automatically identified may not have been verified by the study sponsor.