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Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial

Clinical Effectiveness of Hypertonic Dextrose Prolotherapy in Chronic Ankle Instability: A Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040213
Enrollment
Unknown
Registered
2020-11-25
Start date
2020-12-01
Completion date
Unknown
Last updated
2022-03-14

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

Conditions

Chronic ankle instability

Interventions

Group 1:dextrose 15%

Sponsors

Investigator sponsored trial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: The inclusion criteria include age >=18 years old, with a diagnosis of CAI, defined as having at least 1 significant ankle sprain, and at least 2 episodes of giving way in the 6 months prior to study enrollment ,and a Cumberland Ankle Instability Tool (CAIT) score 20%.

Exclusion criteria

Exclusion criteria: The exclusion criteria include acute ankle sprain <=6 months; complete tear of ATFL confirmed by USG or MRI; a history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures, nerves) in either lower extremity; acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (ie, sprains, fractures), resulting in at least 1 interrupted day of desired physical activity; a history of a fracture in either lower extremity requiring realignment; high ankle sprain, generalized ligament laxity; pregnancy; on anti-coagulant therapy; prior ATFL or ankle injections within 3 months; inflammatory or post-infectious ankle arthritis, such as clinically diagnosed rheumatoid arthritis, gouty arthritis, psoriatic arthritis and septic arthritis; history of corn allergy and co-morbidity or lifestyle preventing participation in the study protocol.

Design outcomes

Primary

MeasureTime frame
The Cumberland Ankle Instability Tool (CAIT);

Secondary

MeasureTime frame
Total number of re-sprains;Star Excursion Balance Test (SEBT);EuroQoul-5 dimensions questionnaire (EQ-5D-5L);Utilization of health services;Assessment the success of blinding;Chinese version of Foot and Ankle Ability Measure;

Countries

China

Contacts

Public ContactProf. Regina Wing-Shan SIT

The Chinese University of Hong Kong

reginasit@cuhk.edu.hk+852 2609 5388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026