Condition category
Musculoskeletal Diseases
Date applied
10/03/2014
Date assigned
10/06/2014
Last edited
10/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
“Frozen shoulder” or “adhesive capsulitis” is a painful and debilitating stiffening-up of the shoulder that usually happens for no apparent reason. It affects large numbers of people every year. It is costly to society, since it can cause people to be off work for extended periods of time and causes a considerable burden on health services. Generally it gets better by itself over a period of 6 to 18 months. However, in some people it can last as long as three years and leave the sufferer with a permanent loss of shoulder joint movement. When this happens, surgical manipulation of the joint or key-hole surgery may be required to restore movement to the joint. The latter is a more precise technique that has less risk of complications. Keyhole surgery to release a persistent frozen shoulder (arthroscopic capsular release) is an effective treatment. However, it does require extensive physiotherapy after the operation to stop the shoulder stiffening up again and to optimise function. This can be problematic as physiotherapy can be hampered by the pain that inevitably follows surgery. Previous research has shown that replacement of the natural joint oil, which gets washed away during the surgery, with an artificial lubricant, gives improvements in pain and function. However, it has not been established whether this is effective after key-hole surgery for frozen shoulder. This study intends to find out whether an artificial lubricant, known as Viscoseal®, can help people in their recovery after key-hole surgery for their stiff shoulder. Viscoseal® has a proven safety-record and is licensed to be used for injection into joints in Britain, Europe and the United States.

Who can participate?
Everyone aged 18 or over being placed on the waiting list for arthroscopic capsular release at Salford Royal NHS Foundation Trust Hospital can take part in the study.

What does the study involve?
Participation in the study will involve each participant being split into one of two groups. All participants are then asked to fill in a questionnaire and undergo a physical assessment before having conventional surgery for frozen shoulder. Group 1 will receive an injection of 10 millilitres (2 teaspoons) of Viscoseal® at the end of the operation and group 2 will not. All participants are then given conventional physiotherapy. They will be asked to complete questionnaires at home in weeks 2 and 4 after surgery. They will also be asked to attend a physiotherapy out-patient department for a physical assessment by a research physiotherapist and complete questionnaires 5 weeks, 3 months and, finally, 6 months after surgery.

What are the possible benefits and risks of participating?
Benefits: We cannot say that there will be any direct benefits. Artificial joint lubricants, such as Viscoseal®, seem to be helpful in reducing pain and improving function after arthroscopy. Patients receiving the Viscoseal® may experience similar improvements in pain and function afterwards. However, we cannot guarantee that it will be effective.
Risks: It is known from previous studies that approximately 1-in-20 people experience a mild and short-lived flare-up when artificial joint lubricants, such as Viscoseal®, are injected into their joints. This can result in some degree of warmth, swelling and discomfort/ pain in the joint, which is likely to be indistinguishable from normal post-surgical inflammation. This usually responds to rest and simple anti-inflammatories, such as Ibuprofen.

Where is the study run from?
Salford Royal Hospital, UK

When is the study starting and how long is it expected to run for?
From April 2014 to April 2016

Who is funding the study?
TRB Chemedica (UK)

Who is the main contact?
Ruth Battersby
Tel: +44(0)161 206 5328 or +44(0)161 206 1077.

Trial website

Contact information

Type

Scientific

Primary contact

Miss Ruth Battersby

ORCID ID

Contact details

Physiotherapy Department
Salford Royal NHS Foundation Trust
Stott Lane
Salford
M68HD
United Kingdom
+44 (0)161 206 1077
Ruth.Battersby@srft.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013/138DERM S

Study information

Scientific title

Viscoseal Post Arthroscopic Release of Adhesive Capsulitis of the Shoulder: a randomised controlled pilot study

Acronym

ViPARACS

Study hypothesis

Aims of the proposed research
The overall aim is to investigate the principle that a single infusion of fermentative-source sodium hyaluronate (Viscoseal®) at the end of an arthroscopic capsular release procedure may be effective in helping control post-operative pain and in optimising function, leading to superior outcomes in the medium-term (4 weeks). The results of this study will be used to establish if further investigation into this is warranted and to inform the design of such studies in the future.

Primary objective
To establish whether a single injection of Viscoseal® may result in improved pain control and function in the medium term (4 weeks) for people undergoing rehabilitation post- arthroscopic capsular release for refractory adhesive capsulitis of the shoulder.

Secondary objectives
1. To assess the feasibility of this investigational approach and its acceptability to patients.
2. To give some indication of what effect sizes can be expected from this treatment.

Ethics approval

NRES Committee North West - Greater Manchester East; 05/02/2014; ref: 14/NW/0012

Study design

Phase 4 pilot study single-centre randomised controlled blinded-assessor design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.citizenscientist.org.uk/research-opportunities/volunteer-patients/viscoseal-study/

Condition

Adhesive Capsulitis of the Shoulder

Intervention

All will be randomised to receive either a 10ml infusion of fermentative source sodium hyaluronate (Viscoseal®) into the joint, following evacuation of saline at the end of the operative procedure, or no infusion at all into the joint.

All will receive subcutaneous marcain 0.5% injections to incision points post-operatively, as is current practice at Salford Royal NHS Foundation Trust (SRFT).

All will undergo routine standardised physiotherapy post-operatively and will be followed up for a period of 6 months after their surgery.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Difference in mean Constant-Murley Score between experimental and control groups in study week five post-surgery (i.e. 32 days, +/-6 days).

This widely-used measure combines subjective ratings of pain and function with objective measures of range-of-motion and strength at the shoulder66. It is recommended by The European Society of shoulder and elbow surgery as a gold standard for the assessment of shoulder function. It consists of four subscales of pain, activities of daily living, strength and range of motion. It has been shown to be a valid, reliable and responsive instrument that correlates strongly with shoulder-specific questionnaires.

Secondary outcome measures

1. Difference in mean Constant-Murley score in weeks 13 and 25 post-operatively (i.e. 88 days, +/-13 days, and 172 days +/-13 days, respectively).
2. Difference in mean Oxford Shoulder Score pre-operatively and in weeks five (32 days, +/-6 days), 13 (88 days, +/-13 days) and 25 (172 days +/-13 days) post-operatively.
3. Difference in mean EQ-5D-3L scores pre-operatively and in weeks two (11 days, +/-6 days), five (32 days, +/-6 days), 13 (88 days, +/-13 days) and 25 (172 days +/-13 days) post-operatively.

The following outcome measures will also be taken:
1. The Disabilities of the Arm, Shoulder and Hand (DASH) Score and a measure of pain in last 24 hours (11-point numerical rating scale) will be taken pre-operatively and in weeks two (11 days, +/-6 days), four (25 days, +/-6 days), five (32 days, +/-6 days), 13 (88 days, +/-13 days) and 25 (172 days +/-13 days) post-operatively.
2. Global change in the shoulder problem, will be measured via one likert-response-type question in weeks two (11 days, +/-6 days), four (25 days, +/-6 days), five (32 days, +/-6 days), 13 (88 days, +/-13 days) and 25 (172 days +/-13 days) post-operatively.
3. The persistence of shoulder pain symptoms, and the “bothersomeness” of the shoulder problem, will be measured via two likert-response-type questions pre-operatively in weeks five (32 days, +/-6 days), 13 (88 days, +/-13 days) and 25 (172 days +/-13 days) post-operatively.

The acceptability of this investigational approach to participants will be assessed by Likert-response-type and free-text-response-type questions on the occasion of the last data collection time-point 25 weeks (172 days +/-13 days) post-operatively.

Overall trial start date

01/04/2014

Overall trial end date

01/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

All adults aged 18 years or over listed for arthroscopic capsular release of the shoulder, who are willing and able to give written informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Known or anticipated adverse reaction to artificial hyaluronans
2. Diagnosis of inflammatory arthropathy
3. Adhesive capsulitis secondary to pathology of the CNS
4. Inability to understand English to a sufficient level to be able to follow study procedures (every effort will be made to provide translators and assistive communication)
5. Inability to provide informed consent
6. Previous arthroplasty involving the target joint
7. Concurrent participation in another interventional research study

Recruitment start date

01/04/2014

Recruitment end date

01/04/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Department
Salford
M68HD
United Kingdom

Sponsor information

Organisation

Salford Royal NHS Foundation Trust (UK)

Sponsor details

c/o Ms Rachel Georgiou
Stott Lane
Salford
M6 8HD
United Kingdom
+44(0)161 206 7032
Rachel.Georgiou@manchester.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

TRB Chemedica (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes