Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia

Comparison Between Steroid and Two Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized Double-blind Active Drug-controlled Pilot Study

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02767635

Enrollment

Registered

2016-05-10

Start date

2012-01-31

Completion date

2016-12-31

Last updated

2016-05-10

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

Conditions

Tennis Elbow

Brief summary

The aim of the study is to compare two different injection sites of low dose botulinum toxin type A with steroid in treating lateral epicondylalgia.

Detailed description

Lateral epicondylalgia or tennis elbow is a common painful elbow disorder with a prevalence of 1% to 3% in the general population and has a higher rate up to 14.5% in strenuous jobs. Botulinum toxin type A injection was an emerging option in treating lateral epicondylalgia. In this study, the patients were randomly assigned into three groups: 1. Botox-Epic group received 20 units of Botox injection into lateral epicondyle; 2. Botox-Tend group had 20 units of Botox injected into tender point of muscles; 3. Steroid group had 40mg of triamcinolone injected into lateral epicondyle. The aim of this randomized controlled study was to compare the effects of injection with corticosteroid and botulinum toxin type A via two different sites in patients with lateral epicondylalgia.

Interventions

DRUGBotox-Epic

injected 20 units of Botox into lateral epicondyle in Botox-Epic group

DRUGBotox-Tend

injected 20 units of Botox into tender point of muscles in Botox-Tend group

DRUGtriamcinolone acetonide (Steroid)

injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* spontaneous local pain over lateral epicondyle of the affected elbow for more than six months and failure to respond to previous physical therapy or oral medications, * local tenderness around the lateral epicondyle, and * pain elicited or aggravated by resisted contraction of the wrist or middle finger extensors.

Exclusion criteria

* local steroid injection within the past six months, * coexisting elbow arthritis or arthralgia, * previous trauma or surgery history over the lateral epicondyle, * pregnancy or lactation, and * other systemic, neuromuscular or bleeding disorders that are contraindicated to Botox injection.

Design outcomes

Primary

Measure	Time frame
Change of pain assessed on the visual analogue scale	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary

Measure	Time frame
Change of grip strength by dynamometer	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation	baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Countries

Taiwan

Contacts

Primary ContactYu-Ching Lin, MD, MSc

richelin@mail.ncku.edu.tw886-6-2353535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026