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

September 22, 2017 updated by: Benjamin Sucher
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline-Week 18
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
Baseline-Week 18
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.
Baseline to Week 18
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
Baseline, week 6, week 12, and week 18.
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.
Baseline to Week 18
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.
Baseline-Week 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benjamin Sucher

Collaborators

Allergan

Investigators

  • Principal Investigator: Benjamin Sucher, DO, Arizona Arthritis & Rheumatology Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85700 (Other Grant/Funding Number: Allergan Sales. LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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