Viscoseal Post Arthroscopic Release of Adhesive Capsulitis of the Shoulder

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71572948

Enrollment

Registered

2014-06-10

Start date

2014-04-01

Completion date

Unknown

Last updated

2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis of the Shoulder Musculoskeletal Diseases Adhesive capsulitis of shoulder

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026