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Trial registered on ANZCTR


Registration number
ACTRN12612000260820
Ethics application status
Approved
Date submitted
1/03/2012
Date registered
2/03/2012
Date last updated
5/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Utility of ultrasound when using shock wave therapy to treat painful calcification in shoulder tendons, achilles tendons and plantar fasciitis with heel spur.
Scientific title
Randomised controlled trial comparing ultrasound-guided to patient-guided extracorporeal shock wave therapy (ESWT) for calcific soft tissue pathologies (including tendinopathy) when assessing patient outcomes of decreased pain, improved function and reduced calcification size.
Secondary ID [1] 280023 0
Nil known
Universal Trial Number (UTN)
U1111-1128-8348
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Painful calcific soft tissue pathologies including tendinopathy. 285934 0
Condition category
Condition code
Musculoskeletal 286124 286124 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive active treatment i.e. shockwave therapy, with the SHOCK WAVE THERAPY PROTOCOL described as below:

1. NUMBER & FREQUENCY OF TREATMENT SESSIONS:
3-5 treatment sessions.
Treatment sessions will be spaced at 1 week intervals.
(NB.Number of sessions of treatment are based on patient's response to treatment. All patients will receive 3 treatment sessions. Patients who feel they have not had a decrease in their pain or improvement in function can have an additional 2 treatment sessions).

2. DURATION OF TREATMENT SESSIONS:
Each treatment session will take between 20-30mins depending on the arm of the study.
Arm 1 (patient-guided shockwave treatment) will take about 20 mins. Arm 2 ( ultrasound-guided shockwave treatment) will take about 30 mins with the additional 10 mins needed to locate the calcification on ultrasound prior to treatment. All session times also include filling out questionnaire prior to treatment, setting up the patient for treatment and arranging the follow up appointment or answering any questions. The shockwave treatment itself takes less than 5 mins.

3.SHOCKWAVE MACHINE SETTINGS:
2000 Impulses, 20 Hz , over a range of 1.4-2 bar.

4. THE TWO STUDY ARMS OF PARTICIPANTS:
Arm 1: Patient-guided shock wave therapy to the area where the most pain is felt in relation to the area of calcification.
Arm 2: Ultrasound-guided shock wave therapy to the exact site of calcification.
Intervention code [1] 284389 0
Treatment: Other
Comparator / control treatment
Shockwave therapy protocol: 3-5 sessions, at 1 week intervals. Shock wave settings at: 2000 Impulses, 20 Hz , over a range of 1.4-2 bar.

Active control: (Arm 1 as above) patient-guided shockwave therapy to the area where the most pain is felt in relation to the area of calcification.
Control group
Active

Outcomes
Primary outcome [1] 286599 0
Patient pain - using a 10 cm visual analogue scale
Timepoint [1] 286599 0
At baseline; during treatment ( prior to each weekly shock wave therapy); following the final shock wave therapy at 6 weeks, 3 months and 6 months
Primary outcome [2] 286600 0
Function - using patient-filled questionnaires relevant to the site of calcification: Constant & Murley Score for shoulder function in calcific shoulder tendinopathy; Victorian Institute of Sport Achillles ( VISA-A) for insertional achilles tendinopathy and; Maryland Foot Score for plantar fasciitis with heel spur.
Timepoint [2] 286600 0
At baseline; during treatment ( prior to each weekly shock wave therapy); following the final shock wave therapy at 6 weeks, 3 months and 6 months
Secondary outcome [1] 296239 0
Calcification size- measured using the investigators ultrasound machine
Timepoint [1] 296239 0
Measured following the final shock wave therapy at 6 weeks, 3 months and 6 months

Eligibility
Key inclusion criteria
Pain in one of 3 areas - either shoulder rotator cuff tendon, achilles tendon or plantar fascia; Proven calcification visible on previous imaging;Calcification visible on our ( the investigator's) ultrasound machine; Males and non-pregnant females; fluent in english; able to give informed consent; seeking to try shockwave treatment as a method to resolve the pain; willing and able to follow the research protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Calcification unable to be seen on our ( the investigator's) ultrasound machine; unable to follow the protocol; unable to tolerate the shock wave treatment according to the protocol because it is too painful; corticosteriod injection to the area inthe last 3 months ( as this may affect treatment efficacy); pregnancy or suspected pregnancy during the study; cancer; local lesions or non-intact skin; osteoarthritis at treatment site; Polyneuropathy; bleeding or clotting conditions; anticoagulation medications; allergy to ultrasound gel.

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)
Letters of recruitement for study will be sent to health care professionals (eg. orthopaedic surgeons, general practitioners, sports medicine doctors, podiatrists). Patients fitting inclusion criteria will be referred to our clinic. Referred, voluntary patients eligible for the study will be randomly allocated to either the "patient-guided" or "ultrasound guided " . Allocation will be by concealment in opaque envelopes. The person giving the shock wave therapy and the patient will not be aware as to which group the patient is in until the envelope is opened prior to the first shock wave treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation. Randomisation done by generating three random number lists (based on site of calcification either shoulder, achilles or plantar fascia) using an excel computer programme. Numbers in each list allocated to either arm 1 ( patient-guided shock wave therapy) or arm 2 ( ultrasound-guided shock wave therapy). Treatment arm put in an opaque envelope. Envelopes numbered sequentially on the outside according to participant number at presentation for treatment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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)

Funding & Sponsors
Funding source category [1] 284780 0
Commercial sector/Industry
Name [1] 284780 0
DJO international
Address [1] 284780 0
P.O Box 2057
Normanhurst, NSW 2076
Country [1] 284780 0
Australia
Primary sponsor type
Individual
Name
Dr John Orchard
Address
The Sports Clinic at Sydney University
University of Sydney
Cnr Western Ave & Physics Road
Camperdown
NSW 2006
Country
Australia
Secondary sponsor category [1] 283667 0
Individual
Name [1] 283667 0
Dr Masiiwa Njawaya
Address [1] 283667 0
The Sports Clinic at Sydney University
University of Sydney
Cnr Western Ave & Physics Road
Camperdown
NSW 2006
Country [1] 283667 0
Australia
Other collaborator category [1] 260571 0
Individual
Name [1] 260571 0
Dr Tim Driscoll
Address [1] 260571 0
A27 Edward Ford Building
University of Sydney,
Camperdown
NSW 2006
Country [1] 260571 0
Australia
Other collaborator category [2] 260572 0
Individual
Name [2] 260572 0
Jessica Orchard
Address [2] 260572 0
NSW Cancer Council
153 Dowling St
Woolloomooloo
NSW 2011
Country [2] 260572 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286772 0
Human Research Ethics Committee, University of Sydney
Ethics committee address [1] 286772 0
Level6
Jane Foss Russell Building G02
University of Sydney
NSW 2006
Ethics committee country [1] 286772 0
Australia
Date submitted for ethics approval [1] 286772 0
Approval date [1] 286772 0
22/02/2012
Ethics approval number [1] 286772 0
14497

Summary
Brief summary
The purpose of the study is to determine the best shock wave therapy protocol for a widely used treatment for calcific soft tissue conditions in musculoskeletal medicine. We would like to see whether the addition of ultrasound to shock wave therapy in treatment of calcific soft tissue pathologies improves patient outcome as determined by decrease in pain, improvement of function and decrease in size of the calcification. We believe that treatment outcome may be similar between groups. However it is possible that for superficial conditions patient guided protocols may be slightly superior. In deep structures such as the shoulder tendon the addition of ultrasound to target the exact area of calcification may be slightly superior . This study will hopefully help answer these questions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33830 0
Address 33830 0
Country 33830 0
Phone 33830 0
Fax 33830 0
Email 33830 0
Contact person for public queries
Name 17077 0
Dr Masi Njawaya
Address 17077 0
The Sports Clinic at Sydney University
University of Sydney
Camperdown
NSW 2006
Country 17077 0
Australia
Phone 17077 0
+ 61 2 93518118
Fax 17077 0
+ 61 2 93518123
Email 17077 0
masinjawaya@thesportsclinic.com.au
Contact person for scientific queries
Name 8005 0
Dr Masi Njawaya
Address 8005 0
The Sports Clinic at Sydney University
Cnr University of Sydney
Camperdown
NSW 2006
Country 8005 0
Australia
Phone 8005 0
+61 2 93518118
Fax 8005 0
+61 2 93518123
Email 8005 0
masinjawaya@thesportsclinic.com.au

No information has been provided regarding IPD availability
Summary results
No Results