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Trial registered on ANZCTR


Registration number
ACTRN12615001378516
Ethics application status
Approved
Date submitted
14/12/2015
Date registered
17/12/2015
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of supra-scapular nerve block for the treatment of frozen shoulder: A randomised controlled trial
Scientific title
The efficacy of supra-scapular nerve block for the treatment of frozen shoulder: A randomised controlled trial
Secondary ID [1] 288137 0
None
Universal Trial Number (UTN)
U1111-1177-5644
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
adhesive capsulitis 297015 0
Condition category
Condition code
Musculoskeletal 297264 297264 0 0
Other muscular and skeletal disorders
Anaesthesiology 297299 297299 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, double blind, placebo controlled trial to evaluate the benefit of adding supra-scapular nerve block to an evidence informed management regime (intra-articular corticosteroid injection plus physiotherapy and oral analgesia as appropriate) for the adhesive capsulitis.

Standard care:
1. Patient education (verbal format) detailing the pathology and self limiting nature of adhesive capsulitis.
2. An initial single delivery Gleno-humeral joint (intra-articular space) injection (20 mg Triamcinolone acetonide (0.5 ml Kenalog) and 1.5 ml 2% Lidocaine Hydrochloride (Xylocaine)).
3. Physiotherapy intervention including passive shoulder mobilization (20 min sessions, 2 x week, first 3 weeks, then 1 x week, following 3 weeks) and a twice daily 20 min self mobilization program. Physiotherapy program to be repeated with subsequent supra-scapular nerve blocks (up to 4 over a 12 month period).

Active arm: Supra-scapular nerve block injection (10ml of 0.5% bupivacaine and 40mg of methylprednisolone) administered by the principal investigator (Rheumatologist) as described by Dangoisse et al (1994). Repeated at 3 monthly intervals over 12 months, should any or all of the following criteria be met:
1. A Patient Perceived Rate of Recovery of less than "good to very good Improved" on the 5 point ordinal scale (including the response categories ‘‘worse’’, ‘‘unchanged’’, ‘‘unsatisfactory improved’’, ‘‘satisfactory improved’’ and ‘‘good to very good improved’’)
2. A self-assessment of ongoing pain greater than 1/10 on the visual analogue scale
3. An ongoing deficit of more than 20% of expected full active shoulder range of motion, as determined by the un-involved or contralateral shoulder range of motion.

Adherence will be monitored using the following methods:
1. The principal investigator will record (log) the date of initial and subsequent active or placebo injections
2. The metrologist will record outcome measures at 3, 6, 9, 12, 18 and 24 months.
3. The physiotherapist will record (log) the participant's attendance
4. The participant will record (log) adherence with the home mobilisation program

Intervention code [1] 293447 0
Treatment: Drugs
Intervention code [2] 293448 0
Rehabilitation
Comparator / control treatment
Control (Placebo) arm: A sham 5ml injection of normal saline delivered subcutaneously in the same manner as the active arm (Dangoisse et al (1994)) with the exception of the depth of delivery. Repeated at 3 monthly intervals over 12 months, as clinically indicated.

Control group
Placebo

Outcomes
Primary outcome [1] 296853 0
The primary outcome is range of shoulder motion (active and passive shoulder flexion, abduction and external rotation range of motion). Range of motion will be measured by the metrologist with a standard goniometer in the upright (active) and supine (passive) position.

Timepoint [1] 296853 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)
Secondary outcome [1] 319530 0
Shoulder Pain and Disability Index (SPADI)- 13 items divided into two subscales: pain (five items) and disability (eight items),
Timepoint [1] 319530 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)
Secondary outcome [2] 319576 0
Patient Perceived Rate of Recovery (5-point ordinal scale) including the response categories ‘‘worse’’, ‘‘unchanged’’, ‘‘unsatisfactory improved’’, ‘‘satisfactory improved’’ and ‘‘good to very good improved’’
Timepoint [2] 319576 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)
Secondary outcome [3] 319577 0
Pain perception (10 cm) Visual Analogue Scale (VAS)
Timepoint [3] 319577 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)
Secondary outcome [4] 319578 0
Pain Catastrophising Scale (13 item ordinal scale) intended to assess for potential negative cognitive–affective responses to pain, including assessment for magnification, rumination and helplessness.
Timepoint [4] 319578 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)
Secondary outcome [5] 319579 0
Quantitative Sensory Testing (QST) incorporating hot, cold and mechanical sensory detection and pain thresholds. Hot and cold testing will be conducted by the TSA­II Neurosensory Analyzer (MEDOC). Mechanical detection threshold will be assessed by an Electronic von Frey Anesthesiometer using flexible von Frey hairs that exert a force of between 0.25Nm and 512Nm.
Timepoint [5] 319579 0
Outcome measures will be taken at 3, 6, 9 and 12 months (coinciding with repeat interventions) and then again at 6 and 12 months following the intervention period (18 and 24 months post baseline).
The endpoint will be 12 months after the completion of the intervention (24 months from baseline)

Eligibility
Key inclusion criteria
Patients with progressive shoulder pain and stiffness in predominantly one shoulder for at least 3 months and of a minimum of 3 on a 10 cm visual analogue scale; restriction of active and passive range of motion greater than 30 degrees in two or more planes of movement (external rotation and abduction), a satisfactory x-ray, and adults aged over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with systemic inflammatory joint disease; radiological evidence of osteoarthritis of the shoulder or fracture; calcification in the region around the shoulder; clinical signs of a complete rotator cuff tear including, notable weakness of arm elevation, a “positive drop sign”, a high riding humeral head on radiological examination or demonstration of complete rotator cuff tear on ultrasound or MRI; allergy to local anaesthetic or iodinated contrast, pregnancy; likely not to comply with follow up or lack of written informed consent.

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 concealment - central randomisation by phone/fax/computer.
Patients will be randomised into two groups using computer generated random numbers from 1 to 50 in which odd and even numbers correspond to the active and control treatment arms A and B respectively.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power calculations: In order to detect a 50% improvement in the range of shoulder abduction movement it is estimated that approximately 25 subjects will be required in each arm of the study with 80% power and significance of 0.05.
All analyses will be carried our using SPSS and Stata software (Statacorp, College Station, Texas, USA). An intension to treat will be performed. The mean and standard deviation of change from baseline will be determined at all time points for all outcome measures. Differences in mean change between supra-scapular nerve block and control groups will be calculated, and their significance assessed by an independent samples t-test, establishing p values and 95% confidence intervals.
To determine correlations between physical and self-report outcome measures and QST measures for the identification of sensitisation, repeated measure ANOVA’s will be used. Significance will be set at p<0.05.

Recruitment
Recruitment status
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)
SA
Recruitment hospital [1] 4940 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 4941 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 12448 0
5042 - Bedford Park
Recruitment postcode(s) [2] 12449 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 292555 0
Charities/Societies/Foundations
Name [1] 292555 0
Arthritis Australia
Address [1] 292555 0
Arthritis Australia
Level 2/255 Broadway
GLEBE NSW 2037
Country [1] 292555 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 291274 0
None
Name [1] 291274 0
Address [1] 291274 0
Country [1] 291274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294030 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 294030 0
The Flats G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 294030 0
Australia
Date submitted for ethics approval [1] 294030 0
21/08/2015
Approval date [1] 294030 0
08/12/2015
Ethics approval number [1] 294030 0
359.15

Summary
Brief summary
Frozen shoulder is a condition which involves pain and stiffness of the shoulder joint and is often associated with a significant restriction of arm function and quality of life or well-being. We would like to see whether there are treatments that are better at reducing pain and improving the stiffness than our current treatments.
The current treatment approach is called a “glenohumeral joint corticosteroid injection”. The glenohumeral joint is the shoulder joint capsule. It involves an injection of a steroid medication and a local anaesthetic agent into the shoulder joint capsule. Physiotherapy exercises are then given. It is thought that the steroid reduces the inflammation and pain around the shoulder joint which then allows the shoulder to be moved more easily with physiotherapy exercises.
The newer approach we want to test is called “supra-scapular nerve block”. This has been shown to be safe and helpful in reducing pain for people with other types of shoulder problems. The treatment involves an injection of a steroid medication and a local anaesthetic agent into the tissues over the shoulder blade. This injection temporarily blocks the supra-scapular nerve which transmits the pain associated with frozen shoulder. Like the current treatment approach, once the pain has been reduced it should be easier to get the shoulder moving again with physiotherapy exercises. It is possible to repeat the suprascapular nerve block up to 4 times, at 3 monthly intervals, if the pain and stiffness remain. We think that the rate of recovery from frozen shoulder might be faster when current treatment and repeated supra-scapular nerve blocks are done together.
In order to test this, participants will be randomly placed into one of two groups. One group will receive the supra-scapular nerve block injection and the other group will receive the placebo (saline) injection. These injections may be performed up to 4 times over the course of 1 year. In addition to receiving either the supra-scapular nerve block or the placebo injection, participants will receive the current best treatment available (glenohumeral joint injection and physiotherapy). Baseline information will be collected including age, general medical health, current medications, duration of shoulder symptoms, severity of shoulder symptoms and previous treatment for shoulder symptoms. Measures of shoulder range of motion, participant’s pain scores and levels of satisfaction will be measured at 3, 6, 9, 12, 18 and 24 months in order to compare both treatment approaches.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62162 0
Prof Michael Shanahan
Address 62162 0
Rheumatologist & Occupational Physician
Head of Rheumatology
Southern Area Local Health Network
Assistant Dean
School of Medicine, Flinders University

Rheumatology Unit
Repatriation General Hospital
Daws Road, Daw Park South Australia 5041

Country 62162 0
Australia
Phone 62162 0
+61 8 82046183
Fax 62162 0
+61 8 8275 1138
Email 62162 0
Michael.Shanahan@sa.gov.au
Contact person for public queries
Name 62163 0
Ms Liz Briggs
Address 62163 0
Southern Area Local Health Network
Rheumatology Service
GP Plus Marion Specialist Clinics
10 Milham Street Oaklands Park SA 5046
Country 62163 0
Australia
Phone 62163 0
+61 8 8275 1819
Fax 62163 0
+61 8 8204 4150
Email 62163 0
liz.briggs@sa.gov.au
Contact person for scientific queries
Name 62164 0
Prof Michael Shanahan
Address 62164 0
Rheumatologist & Occupational Physician
Head of Rheumatology
Southern Area Local Health Network
Assistant Dean
School of Medicine, Flinders University

Rheumatology Unit
Repatriation General Hospital
Daws Road, Daw Park South Australia 5041
Country 62164 0
Australia
Phone 62164 0
+61 8 8275 1706
Fax 62164 0
+61 8 8275 1138
Email 62164 0
Michael.Shanahan@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results