Condition category
Musculoskeletal Diseases
Date applied
24/05/2016
Date assigned
25/05/2016
Last edited
25/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Adhesive capsulitis (also known as frozen shoulder) is a condition that leads to pain and stiffness of the shoulder. Clinical studies have reported the safety and effectiveness of injecting hyaluronate into the shoulder joint of patients with adhesive capsulitis. The aim of this study is to assess the effectiveness of a hyaluronate and tramadol injection for adhesive capsulitis of the shoulder.

Who can participate?
Patients with adhesive capsulitis of the shoulder

What does the study involve?
Participants are randomly allocated to the hyaluronate group or the tramadol group. Hyaluronate group members receive five weekly hyaluronate injections. Tramadol group members receive three weekly hyaluronate and tramadol injections, and then two weekly injections of hyaluronate. Range of motion of the shoulder joint and shoulder pain are assessed at the start of the study and 1, 2, 3, 4, and 6 weeks after the first injection.

What are the possible benefits and risks of participating?
Participating helps us to find more effective treatments and does not exceed the minimum risk that may arise in day-to-day treatment.

Where is the study run from?
Soonchunhyang University Hospital (South Korea)

When is the study starting and how long is it expected to run for?
June 2014 to April 2015

Who is funding the study?
Soonchunhyang University (South Korea)

Who is the main contact?
Prof. Ki Young Oh

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ki Young Oh

ORCID ID

http://orcid.org/0000-0002-1886-5462

Contact details

Soonchunhyang University Cheonan Hospital
Bongmyeong-dong
Dongnam-gu
Cheonan-si
Chungcheongnam-do
Cheonan
330-721
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SCH-2014-0001

Study information

Scientific title

The effect of intra-articular hyaluronate and tramadol injection on patients with adhesive capsulitis of the shoulder: a single-blind randomised control trial

Acronym

Study hypothesis

More significant changes occur in pain, ROM, and function of shoulder joints when hyaluronate and tramadol are injected together into the joints as treatment for adhesive capsulitis of the shoulder than injected hyaluronate alone.

Ethics approval

Institutional Review Board of Soonchunhyang University Hospital, March 2014

Study design

Single-blind randomised control trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Adhesive capsulitis of shoulder

Intervention

The control group (hyaluronate group) was injected only with hyaluronate (Hyal Shin Poong, PhD, Korea, 2.5-mL injection, 1% hyaluronan, molecular weight 940–1,020 kDa) five times in 1-week intervals.

The experimental group (tramadol group) received hyaluronate and tramadol (Tridol Shin Poong, PhD, Korea, 100 mg, 1-mL injection) 50-mg injections three times, and then they received two injections of only hyaluronate afterward. Intra-articular injection was administered by one doctor using the posterior approach

Intervention type

Drug

Phase

Not Applicable

Drug names

Hyaluronate, tramadol

Primary outcome measures

Visual Analog Scale (VAS), passive range of motion (PROM) of the shoulder joint, and Shoulder Pain and Disability Index (SPADI) scores were assessed at baseline and weeks 1, 2, 3, 4, and 6 after the initial injection.

Secondary outcome measures

N/A

Overall trial start date

01/06/2014

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who visited the Outpatient Clinic at Soonchunhyang University Hospital
2. Pain and limited movement of the shoulder joints

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Trauma
2. Stroke
3. Endocrine diseases
4. Arthritis in the shoulder
5. They had been administered an MAO (Monoamin monoamine oxidase) inhibitor during the past 2 weeks
6. They had hypersensitivity to opioids
7. They had received an intra-articular injection in the shoulder during the past 6 months
8. They had undergone other surgeries
9. They had been experiencing symptoms for more than 9 months
10. Ultrasonography showed a full-thickness tear in some tendons of the rotator cuff

Recruitment start date

01/06/2014

Recruitment end date

01/02/2015

Locations

Countries of recruitment

Korea, South

Trial participating centre

Soonchunhyang University Hospital
31151
Korea, South

Sponsor information

Organisation

Soonchunhyang University (South Korea)

Sponsor details

Bongmyeong-dong
Dongnam-gu
Cheonan-si
Chungcheongnam-do
Cheonan
330-721
Korea
South

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Soonchunhyang University

Alternative name(s)

SCH

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Korea, South

Results and Publications

Publication and dissemination plan

I hope to publish the results within this year (2016)

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes