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

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ClinicalTrials.gov Identifier: NCT02070302
Recruitment Status : Completed
First Posted : February 25, 2014
Results First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.

Tracking Information
First Submitted Date  ICMJE February 20, 2014
First Posted Date  ICMJE February 25, 2014
Results First Submitted Date  ICMJE March 10, 2017
Results First Posted Date  ICMJE September 27, 2017
Last Update Posted Date September 27, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
Change from baseline Levine Scale function and symptom severity at week 6, week 12, and week 18. [ Time Frame: baseline, week 6, week 12, and week 18 ]
Change History Complete list of historical versions of study NCT02070302 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
Change from baseline JAMAR pinch dynamometer muscle weakness at week 6, week 12, and week 18. [ Time Frame: baseline, week 6, week 12, and week 18 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 24, 2014)
  • Change from baseline Electrodiagnostics distal sensory latency at week 6, week 12, and week 18. [ Time Frame: Baseline, week 6, week 12, and week 18. ]
  • Change from baseline in nerve swelling in compression on Neuromuscular Ultrasound at week 6, week 12, and week 18. [ Time Frame: baseline, week 6, week 12, and week 18. ]
 
Descriptive Information
Brief Title  ICMJE BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
Official Title  ICMJE BOTOX® (Onabotulinumtoxin A) Injection(s) as a Treatment for Carpal Tunnel Syndrome
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carpal Tunnel Syndrome
Intervention  ICMJE
  • Drug: Botulinum Toxin Type A
    40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
    Other Name: Botox
  • Drug: Placebo
    Placebo (Normal Saline) divided into 2 injections of .4cc each
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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)
    Intervention: Drug: Botulinum Toxin Type A
  • 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)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02070302
Other Study ID Numbers  ICMJE 85700
85700 ( Other Grant/Funding Number: Allergan Sales. LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.
Study Sponsor  ICMJE Benjamin Sucher
Collaborators  ICMJE Allergan
Investigators  ICMJE
Principal Investigator: Benjamin Sucher, DO Arizona Arthritis & Rheumatology Research
PRS Account Arizona Arthritis & Rheumatology Research, PLLC.
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP