ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

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]

Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.

Primary outcome [2]

Numeric Rating Scale for level of shoulder pain. 0 = no pain and 10 being the worst pain imaginable.

Timepoint [2]

Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.

Primary outcome [3]

SPADI outcome measure (Shoulder Pain and Disability Index).

Timepoint [3]

Measurements taken initially and repeated at three weeks, six weeks (physiotherapy intervention ceases here), nine weeks and twelve weeks.

Secondary outcome [1]

Painful shoulder range of motion using standard plastic goniometer by the one principal investigator.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4810 - Townsville

Funding & Sponsors

Funding source category [1]

University

Name [1]

James Cook University

Address [1]

James Cook University
1 James Cook Drive
Douglas 4811
Queensland

Country [1]

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]

Individual

Name [1]

Dr Susan Gordon

Address [1]

Professor Susan Gordon PhD Supervisor School Of Health Sciences, Flinders University 17 Rockville Avenue Daw Park 5041 South Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

James Cook University Human Ethics Committee

Ethics committee address [1]

James Cook University
1 James Cook Drive
Douglas  4811
Queensland.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/05/2015

Approval date [1]

02/07/2015

Ethics approval number [1]

H6129

Summary

Brief summary

Shoulder impingement is a common diagnosis referred for physiotherapy treatment. Patients complain of pain when lifting their arm and difficulty with functions such as washing their hair or when reaching for objects. (Michener, McClure et al. 2003) suggest “it is the most common disorder of the shoulder, accounting for 44-65% of all complaints of shoulder pain during a physician’s office visit.”  In addition, approximately one-fifth of all disability payments for musculoskeletal disorders are for shoulder disorders (Michener, Walsworth et al. 2004)
These statistics indicate that a large portion of the general community may be affected by a shoulder disorder and that it causes significant discomfort and limitation to their function.
Physiotherapists use past clinical experience in addition to a thorough examination to identify physical characteristics causing signs of impingement and which are able to be modified (Sorohan and Mc Creesh 2009). A study has been completed (JCU ethics approval number H3945) which took an homogeneous group, aged 40 to 60 years, presenting with positive shoulder impingement signs and symptoms of gradual onset and without trauma, and compared these physical characteristics to a matched asymptomatic group in age and physical activity level. Significant differences between groups were found in upper back (thoracic) posture, range of upper back (thoracic) movement and tightness in the back of the shoulder. No significant differences were found in shoulder muscle strength or shoulder blade positioning. 
This prospective, randomized double blinded,control trial will compare the clinical efficacy of two evidence based physiotherapy treatment approaches (one directed at the thoracic spine and one directed at the posterior shoulder) as compared to ultrasound treatment.
 The results of this project will result in the development of an evidence based program to manage shoulder impingement.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/369106-Approval Form H6129 Land.pdf (Other)

Attachments [2]

/AnzctrAttachments/369106-SIGNED REPORT.pdf (Other)

Contacts

Principal investigator

Name

Mrs Helen Land

Address

JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland

Country

Australia

Phone

+61747815840

Fax

+61747792739

helen.land@jcu.edu.au

Contact person for public queries

Name

Helen Land

Address

JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland

Country

Australia

Phone

+61747815840

Fax

+61747792739

helen.land@jcu.edu.au

Contact person for scientific queries

Name

Helen Land

Address

JCU Physiotherapy Clinic
Level 1, Building 500, Clinical Practice Building
James Cook University
1 James Cook Drive
Douglas 4811
Queensland

Country

Australia

Phone

+61747815840

Fax

+61747792739

helen.land@jcu.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Effect of manual physiotherapy in homogeneous individuals with subacromial shoulder impingement: A randomized controlled trial.	2019	https://dx.doi.org/10.1002/pri.1768

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically