Study to compare the effects of steroid injection vs steroid injection and hydrodilatation in the treatment of adhesive capsulitis

ISRCTN ISRCTN11696305
DOI https://doi.org/10.1186/ISRCTN11696305
Secondary identifying numbers 14/0669
Submission date
19/04/2015
Registration date
02/05/2015
Last edited
12/10/2018
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Frozen shoulder (adhesive capsulitis) is a common condition affecting 3 in every 100 people. Frozen shoulder occurs due to inflammation (swelling) in the lining of the shoulder joint (capsule), which causes the lining to become scarred. The scar tissue sticks to the bone, restricts shoulder movement and causes pain. Sufferers normally experience the symptoms of frozen shoulder for around 18 to 24 months. Frozen shoulder usually clears up by itself, therefore available treatments are generally aimed at managing the signs and symptoms of the condition while it is active. There are two treatments commonly available to relieve symptoms of frozen shoulder: hydrodilatation and steroid injection. Hydrodilatation describes a treatment where saline solution, steroid and local anaesthetic are injected into the shoulder to expand the lining of the joint that has become restricted. The procedure happens under local anaesthetic (patient is awake but the shoulder is numbed) and takes around 15 minutes. Steroid injection treatment is when a steroid (e.g. corticosteroids) is injected directly into the lining of the shoulder while the patient is under local anaesthetic. Both treatments aim to reduce pain and inflammation, and improve movement in the affected shoulder. At the moment there is very little evidence comparing the two treatments, so it is not clear if one works better than the other. The aim of this study is to test steroid injections and a combined steroid injections-hydrodilatation treatment and compare how well they work at managing pain, reducing inflammation and improving movement in patients with frozen shoulder.

Who can participate?
Adults with frozen shoulder.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given steroid injections for the affected shoulder. Those in group 2 (intervention group) are given combined steroid injections and hydrodilatation treatment. All participants complete questionnaires and attend clinical assessments before treatment, after 6 weeks and then 3 months after treatment.

What are the possible benefits and risks of participating?
The results of this study could lead to an effective form of pain relief for this patient group, which would allow them more mobility in their day to day life. A further benefit is associated with the use of ultrasound guidance when administering the steroid injection, which may contribute to improved accuracy and is not always available in standard treatment. There are no additional risks to participating in this study.

Where is the study run from?
University College London Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2015 to April 2018

Who is funding the study?
University College London Hospitals NHS Foundation Trust (UK)

Who is the main contact?
Mr C Cobiella

Contact information

Mr Carlos Cobiella
Scientific

Institute of Sports Exercise and Health
Sports Medicine Clinic
UCLH
170 Tottenham Court Road
London
W1T 7HA
United Kingdom

Study information

Study designRandomised control trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please contact Jonathan Cairns, Jon.A.Cairns@gmail.com, Institute of Sports Exercise and Health, Sports Medicine Clinic, UCLH, 170 Tottenham Court Road, London W1T 7HA
Scientific titleStudy to compare the effects of steroid injection vs steroid injection and hydrodilatation in the treatment of adhesive capsulitis: a randomised control trial
Study objectivesNull hypothesis: hydrodilatation has no added benefit over and above the effect of intra-articular steroid injection in improvement of pain and function in the treatment of adhesive capsulitis.
Ethics approval(s)NRES committee South Central - Oxford B, 13/03/2015, ref: 15/SC/0124.
Health condition(s) or problem(s) studiedAdhesive capsulitis
InterventionChanges to pain, strength and shoulder range of movement are assessed over a 3 month period following one of two two groups:
Group 1. Steroid injection
Group 2. Steroid injection and hydrodilatation
Intervention typeProcedure/Surgery
Primary outcome measureAssessed prior to intervention, after 6 weeks and then 3 months post-intervention:
1. Oxford Shoulder Score (OSS) patient-based questionnaire
2. Visual Acuity Score (VAS)
3. Range of motion (ROM) tests using video analysis
4. Change in strength tested using an isokinetic machine
Secondary outcome measuresAssess patient acceptability of procedural discomfort and satisfaction with results by questionnaire.
Overall study start date09/04/2015
Completion date12/04/2018
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants170 patients from the Upper Limb Orthopaedic department at UCLH
Key inclusion criteria1. Clinical diagnosis of adhesive capsulitis
2. Normal radiograph of the shoulder
3. Restriction of range of motion compared to unaffected shoulder of at least 30 degrees in 2 of three movements; forward flexion, abduction, and external rotation in neutral measured with a goniometer.
4. Able to give informed consent
5. Diabetic, thyroid or post traumatic (e.g. post dislocation) causes may be included (otherwise slower to recruit numbers).
6. Symptoms for any period of time as long as it can be recorded
7. All patients presenting with adhesive capsulitis should be considered for the trial, but it’s the clinician’s choice if they wish to offer other treatments.
Key exclusion criteria1. Patients unable to complete questionnaires
2. Patients under 18 or over 85
3. Any surgical intervention for adhesive capsulitis already performed
4. Pre-existing major trauma or surgery to the shoulder
5. Patients with known or suspected musculoskeletal infection in affected shoulder
6. Patients with known or suspected malignancy
7. Steroid injection to affected shoulder less than six weeks at time of proposed intervention
8. Patient on oral steroids
9. Azathioprin, other DMD disease modifying drugs and medication taken after the intervention, in the periods of 6 weeks and 3 months.
Date of first enrolment16/04/2015
Date of final enrolment09/04/2018

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University College London Hospital
Institute of Sports Exercise and Health
Sports Medicine Clinic
170 Tottenham Court Road
London
W1T 7HA
United Kingdom

Sponsor information

Joint Research Office (part of the Research Support Centre) UCL
University/education

1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Hospital/treatment centre

University College London Hospitals NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date01/04/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPeer-review journal publication and presentation of results at sports medicine-related conferences.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

12/10/2018: The study was stopped due to insufficient recruitment