search
Back to results

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

Primary Purpose

Tennis Elbow

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Botox-Epic
Botox-Tend
triamcinolone acetonide (Steroid)
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Botox-Epic group

Botox-Tend group

Steroid group

Arm Description

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

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

40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group

Outcomes

Primary Outcome Measures

Change of pain assessed on the visual analogue scale

Secondary Outcome Measures

Change of grip strength by dynamometer
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation

Full Information

First Posted
May 6, 2016
Last Updated
May 9, 2016
Sponsor
National Cheng-Kung University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02767635
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Botox-Epic group received 20 units of Botox injection into lateral epicondyle; Botox-Tend group had 20 units of Botox injected into tender point of muscles; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botox-Epic group
Arm Type
Experimental
Arm Description
20 units of Botox injection into lateral epicondyle in Botox-Epic group
Arm Title
Botox-Tend group
Arm Type
Experimental
Arm Description
20 units of Botox injected into tender point of muscles in Botox-Tend group
Arm Title
Steroid group
Arm Type
Active Comparator
Arm Description
40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group
Intervention Type
Drug
Intervention Name(s)
Botox-Epic
Other Intervention Name(s)
onabotulinumtoxinA
Intervention Description
injected 20 units of Botox into lateral epicondyle in Botox-Epic group
Intervention Type
Drug
Intervention Name(s)
Botox-Tend
Other Intervention Name(s)
onabotulinumtoxinA
Intervention Description
injected 20 units of Botox into tender point of muscles in Botox-Tend group
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide (Steroid)
Other Intervention Name(s)
steroid
Intervention Description
injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group
Primary Outcome Measure Information:
Title
Change of pain assessed on the visual analogue scale
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Change of grip strength by dynamometer
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Title
Change of self-assessment by Patient-Rated Tennis Elbow Evaluation
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Ching Lin, MD, MSc
Phone
886-6-2353535
Ext
5258
Email
richelin@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Ching Lin, MD, MSc
Organizational Affiliation
National Cheng-Kung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
138
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Lin
Phone
Tel: 886-6-2353535
Ext
2666
Email
richelin@mail.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27666156
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs