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
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