NCT02767635

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

4.9 years

First QC Date

May 6, 2016

Last Update Submit

May 9, 2016

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

  • Change of pain assessed on the visual analogue scale

    baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

Secondary Outcomes (2)

  • 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

Study Arms (3)

Botox-Epic group

EXPERIMENTAL

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

Drug: Botox-Epic

Botox-Tend group

EXPERIMENTAL

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

Drug: Botox-Tend

Steroid group

ACTIVE COMPARATOR

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

Drug: triamcinolone acetonide (Steroid)

Interventions

Botox-EpicDRUG

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

Also known as: onabotulinumtoxinA
Botox-Epic group
Botox-TendDRUG

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

Also known as: onabotulinumtoxinA
Botox-Tend group
triamcinolone acetonide (Steroid)DRUG

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

Also known as: steroid
Steroid group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital

Tainan, Taiwan, 138, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27666156DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Botulinum Toxins, Type ATriamcinolone AcetonideSteroids

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsTriamcinolonePregnadienesPregnanesFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Yu-Ching Lin, MD, MSc

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Ching Lin, MD, MSc

CONTACT

886-6-2353535richelin@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Physician

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)