Effectiveness of steroid and local anesthetic injection for patients with functional ankle instability
| ISRCTN | ISRCTN51678104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51678104 |
- Submission date
- 08/01/2023
- Registration date
- 11/01/2023
- Last edited
- 07/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Steroid injection is a common treatment for musculoskeletal diseases. However, its effectiveness in functional ankle instability (FAI, a floppy loose ankle) is still controversial. The aim of this study is to find out whether a steroid and local anesthetic injection into the ankle improves ankle function more than health education.
Who can participate?
Patients aged 18 to 50 years with FAI
What does the study involve?
Participants are divided into two groups: the steroid group receives a steroid and local anesthetic injection, and the saline group receives a saline injection. For both groups, the follow-up is at 4, 8 and 12 weeks later.
What are the possible benefits and risks of participating?
Possible benefits include improvement in ankle function, and risks may include injection site infection and local soft tissue damage.
Where is the study run from?
Huashan Hospital, Fudan University (China)
When is the study starting and how long is it expected to run for?
January 2022 to January 2023
Who is funding the study?
National Natural Science Foundation of China
Who is the main contact?
Dr Yungu Chen, yungu_chen@163.com
Contact information
Scientific
12 Middle Wulumuqi Road
Shanghai
200040
China
 ORCID ID |
0000-0002-8486-8098 |
|---|---|
| Phone | +86 (0)21 52889999 |
| yungu_chen@163.com |
Study information
| Study design | Single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Clinical effectiveness of intra-articular steroid and local anesthetic injection for patients with functional ankle instability in the improvement of ankle function compared with health education |
| Study objectives | Intra-articular steroid and local anesthetic injection improves ankle function more than health education |
| Ethics approval(s) | Approved 04/01/2022, Huashan Institutional Review Board (12 Middle Wulumuqi Road, Shanghai, China; +86 (0)21 5288045; licaihong199505@163.com), ref: KY2022-070 |
| Health condition(s) or problem(s) studied | Functional ankle instability |
| Intervention | Current interventions as of 07/02/2023: Randomization process: Patients are randomly assigned to two groups by an independent physician by choosing one of two sealed opaque envelopes. The allocation is performed by an independent researcher without knowing the treatment details. Participants are divided into two groups: the steroid group receives an intra-articular steroid and local anesthetic injection (a mixture of 1 ml of 40 mg/ml triamcinolone and 2 ml 2% lidocaine) immediately after the baseline measurement, and the saline group receives a saline injection immediately after baseline measurement. For both groups, the follow-up is at 4, 8 and 12 weeks after baseline measurement. _____ Previous interventions: Randomization process: Patients are randomly assigned to Group A, B or C by an independent physician by choosing one of three sealed opaque envelopes containing letters A to C, reflecting the three groups, respectively. The allocation is performed by an independent researcher without knowing the treatment details. Participants are divided into three groups: group A receives health education, group B receives an intra-articular steroid and local anesthetic injection (a mixture of 1 ml of 40 mg/ml triamcinolone and 2 ml 2% lidocaine) immediately after the baseline measurement, and group C receives a saline injection immediately after baseline measurement. For all three groups, the follow-up is at 4, 8 and 12 weeks after baseline measurement. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Triamcinolone, lidocaine |
| Primary outcome measure | Pain is measured using a visual analogue scale (VAS) at baseline, 4, 8 and 12 weeks |
| Secondary outcome measures | 1. Ankle function is measured by the Cumberland Ankle Instability Tool (CAIT) at baseline, 4, 8 and 12 weeks 2. Balance performance is measured by a center of pressure (COP) forceplate at baseline, 4, 8 and 12 weeks |
| Overall study start date | 04/01/2022 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Aged 18 to 50 years 2. At least one episode of significant ankle sprain sustained no less than 12 months prior to the recruitment 3. At least one interrupted day of desired physical activity 4. Existing residual symptoms including recurrent ankle sprains, and/or at least two episodes of sprains and/or perceived ankle instability in the previous 6 months 5. Cumberland Ankle Instability Tool (CAIT) scores lower than 24 |
| Key exclusion criteria | 1. A history of fracture requiring realignment or musculoskeletal surgery in either lower extremity 2. Osteoarthritis in either lower extremity, head trauma, inner ear disease, muscular dystrophy, or other conditions that could affect balance control 3. A history of acute injury to the lower extremity within 3 months before the enrollment |
| Date of first enrolment | 01/10/2022 |
| Date of final enrolment | 30/10/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Jingan District
Shanghai
200040
China
Sponsor information
Government
83 Shuangqing Road
Haidian District
Beijing
100085
China
| Phone | +86 (0)10 62317474 |
|---|---|
| support@nsfc.gov.cn | |
| Website | https://www.nsfc.gov.cn |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 05/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact foot and ankle specialist journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available on request from Prof. Xin Ma (prof.xin.ma@qq.com). The type of data: all electronic Excel data used in the study Date of availability: after publication in a journal Whether consent from participants was required and obtained: All participants are required to provide written informed consent Comments on data anonymization: All data are anonymized Any ethical or legal restrictions: This study strictly complies with the local ethical and legal regulations |
Editorial Notes
07/02/2023: The following changes were made to the trial record:
1. The interventions were changed.
2. The plain English summary was updated to reflect these changes.
10/01/2023: Trial's existence confirmed by the Huashan Institutional Review Board.
