Clinical trial NCT02767635: Comparison Between Steroid and Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Tennis Elbow
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of pain assessed on the visual analogue scale
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary outcomes:
measure: Change of grip strength by dynamometer
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
measure: Change of self-assessment by Patient-Rated Tennis Elbow Evaluation
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Yu-Ching Lin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guo YH, Kuan TS, Chen KL, Lien WC, Hsieh PC, Hsieh IC, Chiu SH, Lin YC. Comparison Between Steroid and 2 Different Sites of Botulinum Toxin Injection in the Treatment of Lateral Epicondylalgia: A Randomized, Double-Blind, Active Drug-Controlled Pilot Study. Arch Phys Med Rehabil. 2017 Jan;98(1):36-42. doi: 10.1016/j.apmr.2016.08.475. Epub 2016 Sep 22.