The effect of intra-articular hyaluronate and tramadol injection on patients with adhesive capsulitis of the shoulder
| ISRCTN | ISRCTN13453452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13453452 |
| Protocol serial number | SCH-2014-0001 |
| Sponsor | Soonchunhyang University (South Korea) |
| Funder | Soonchunhyang University |
- Submission date
- 24/05/2016
- Registration date
- 25/05/2016
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
Soonchunhyang University Cheonan Hospital
Bongmyeong-dong
Dongnam-gu
Cheonan-si
Chungcheongnam-do
Cheonan
330-721
Korea, South
 ORCID ID |
0000-0002-1886-5462 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-blind randomised control trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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(s) | Institutional Review Board of Soonchunhyang University Hospital, March 2014 |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Hyaluronate, tramadol |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 01/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 30 |
| Key inclusion criteria | 1. Patients who visited the Outpatient Clinic at Soonchunhyang University Hospital 2. Pain and limited movement of the shoulder joints |
| Key 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 |
| Date of first enrolment | 01/06/2014 |
| Date of final enrolment | 01/02/2015 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/08/2017 | 24/07/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/07/2020: Publication reference added.
