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

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ClinicalTrials.gov Identifier: NCT02767635
Recruitment Status : Unknown
Verified May 2016 by Yu-Ching Lin, National Cheng-Kung University Hospital.
Recruitment status was:  Recruiting
First Posted : May 10, 2016
Last Update Posted : May 10, 2016
Sponsor:
Information provided by (Responsible Party):
Yu-Ching Lin, National Cheng-Kung University Hospital

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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Drug: Botox-Epic Drug: Botox-Tend Drug: triamcinolone acetonide (Steroid) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botox-Epic group
20 units of Botox injection into lateral epicondyle in Botox-Epic group
Drug: Botox-Epic
injected 20 units of Botox into lateral epicondyle in Botox-Epic group
Other Name: onabotulinumtoxinA

Experimental: Botox-Tend group
20 units of Botox injected into tender point of muscles in Botox-Tend group
Drug: Botox-Tend
injected 20 units of Botox into tender point of muscles in Botox-Tend group
Other Name: onabotulinumtoxinA

Active Comparator: Steroid group
40mg of triamcinolone acetonide but not Botox injected into lateral epicondyle in Steroid group
Drug: triamcinolone acetonide (Steroid)
injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group
Other Name: steroid




Primary Outcome Measures :
  1. Change of pain assessed on the visual analogue scale [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]

Secondary Outcome Measures :
  1. Change of grip strength by dynamometer [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]
  2. Change of self-assessment by Patient-Rated Tennis Elbow Evaluation [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767635


Contacts
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Contact: Yu-Ching Lin, MD, MSc 886-6-2353535 ext 5258 richelin@mail.ncku.edu.tw

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 138
Contact: Richard Lin    Tel: 886-6-2353535 ext 2666    richelin@mail.ncku.edu.tw   
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
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Principal Investigator: Yu-Ching Lin, MD, MSc National Cheng-Kung University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yu-Ching Lin, Visiting Physician, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02767635    
Other Study ID Numbers: BR-100-108
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: May 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Botulinum Toxins, Type A
abobotulinumtoxinA
Triamcinolone diacetate
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors