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BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070302
First Posted: February 25, 2014
Last Update Posted: September 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.
  Purpose
This study will be a prospective double blind controlled randomized trial of ten patients diagnosed with Carpal Tunnel Syndrome (CTS). The study will be completed at offices of medical practices in Arizona. Patients who meet inclusion criteria will be randomly distributed into two groups: a BOTOX® (onabotulinumtoxin A) injection group and a Normal Saline Injection (NS) (Placebo group). Each group will consist of five randomly assigned individuals.

Condition Intervention Phase
Carpal Tunnel Syndrome Drug: Botulinum Toxin Type A Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome

Resource links provided by NLM:


Further study details as provided by Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.:

Primary Outcome Measures:
  • Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18. [ Time Frame: Baseline-Week 18 ]
    Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.

  • Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18. [ Time Frame: Baseline-Week 18 ]
    Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40

  • Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18. [ Time Frame: Baseline to Week 18 ]
    Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.

  • Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18. [ Time Frame: Baseline, week 6, week 12, and week 18. ]
    Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline

  • Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18. [ Time Frame: Baseline to Week 18 ]
    Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.

  • Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18. [ Time Frame: Baseline-Week 18 ]
    Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.


Enrollment: 10
Study Start Date: October 2014
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum Toxin Type A
After appropriate consent, each patient will receive 40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Drug: Botulinum Toxin Type A
40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
Other Name: Botox
Placebo Comparator: Placebo
.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)
Drug: Placebo
Placebo (Normal Saline) divided into 2 injections of .4cc each
Other Name: Normal Saline

Detailed Description:

This is a pilot study, to assist with determining appropriate BOTOX® (onabotulinumtoxin A) dosing and injection locations in patients suffering from CTS.

Outcome measures will be obtained at follow-up at 6, 12, and 18 weeks post BOTOX® (onabotulinumtoxin A) injection and post saline injection using the same scales and instruments at baseline, namely Levine scale, JAMAR pinch dynamometer, EDX/NCS and NMUS. These measurements will be used to identify the effectiveness of BOTOX® (onabotulinumtoxin A) in decreasing thenar muscle strength, appropriate BOTOX® (onabotulinumtoxin A) injection dosing, and ability to decrease the inflammation, median nerve dysfunction, edema, symptoms of pain, numbness, and tingling often with associated with CTS.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient history: evaluated using the Levine Scale for CTS, a self-administered questionnaire which assesses the function and severity of CTS.
  • Physical Exam: including use of JAMAR pinch dynamometer to quantify initial baseline strength and confirm decreased pinch strength post injection to verify effective BOTOX® (onabotulinumtoxin A) injection.
  • Electrodiagnostics (EDX): The following criteria would establish CTS through EDX namely baseline electromyogram (EMG) and nerve conduction studies (NCS): a) median nerve distal motor latency (DML) >4.3ms or >0.9ms above the ulnar nerve DML b) median distal sensory latency (DSL) to D-1 >2.9ms or >0.4ms above radial nerve D-1 DSL. c) median D-2 DSL >3.7ms or >0.4ms above ulnar nerve D-5 DSL (5). d) median mixed nerve palm-to-wrist latency (at 8cm) >2.2ms or >.3ms above ulnar mixed nerve palm-to-wrist latency (at 8cm).
  • Imaging & Measurements (NMUS): Carpal tunnel images will be obtained in a transverse plane in both a neutral relaxed position at the level of the pisiform and longitudinally during neutral and Dynamic Stress Testing (DST) by a A Sonosite M-Turbo 6-13 MHz ultrasound system or another similar system (+ 2% accuracy). Measurements: Transverse images of the CT will measure the median nerve cross sectional area (CSA) at the level of the pisiform bone. CSA measurements greater than 11 mm2 are indicative of CTS. Borderline CSA measurements would require wrist forearm ratio (WFR) measurements to be a WFR > 1.5. Patients will need to have a CSA >11mm2, (or WFR >1.5) and show median nerve compression during DST of at least 30% to be included.

Exclusion Criteria:

  • Patients with prior carpal tunnel surgery, prior history of BOTOX® (onabotulinumtoxin A) injection
  • Steroid injection two months prior or three months after BOTOX® (onabotulinumtoxin A) CTS injection, median nerve denervation on needle EMG
  • Major limb trauma or surgery, dysphagia
  • Neuromuscular junction disorder (ie: Myasthenia gravis or Lambert-Eaton syndrome)
  • Currently pregnant or breast feeding
  • Patients with severe CTS identified by Levine scale >4, electrodiagnostics, and/or unable to meet the inclusion criteria as identified above would be excluded as participants in this study.
  Contacts and Locations
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): NCT02070302


Locations
United States, Arizona
Arizona Arthritis & Rheumatology
Phoenix, Arizona, United States, 85032
Sponsors and Collaborators
Benjamin Sucher
Allergan
Investigators
Principal Investigator: Benjamin Sucher, DO Arizona Arthritis & Rheumatology Research
  More Information

Responsible Party: Benjamin Sucher, Principal Investigator, Arizona Arthritis & Rheumatology Research, PLLC.
ClinicalTrials.gov Identifier: NCT02070302     History of Changes
Other Study ID Numbers: 85700
85700 ( Other Grant/Funding Number: Allergan Sales. LLC )
First Submitted: February 20, 2014
First Posted: February 25, 2014
Results First Submitted: March 10, 2017
Results First Posted: September 27, 2017
Last Update Posted: September 27, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Botulinum Toxins
onabotulinumtoxinA
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents