ANZCTR - Registration

Registration number

ACTRN12615001378516

Ethics application status

Approved

Date submitted

14/12/2015

Date registered

17/12/2015

Date last updated

16/07/2021

Date data sharing statement initially provided

5/04/2019

Date results provided

16/07/2021

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]

None

Universal Trial Number (UTN)

U1111-1177-5644

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

adhesive capsulitis

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Anaesthesiology

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]

Treatment: Drugs

Intervention code [2]

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]

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]