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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Arizona Arthritis & Rheumatology Research, PLLC.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Benjamin Sucher, Arizona Arthritis & Rheumatology Research, PLLC.
ClinicalTrials.gov Identifier:
NCT02070302
First received: February 20, 2014
Last updated: February 24, 2014
Last verified: February 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Arizona Arthritis & Rheumatology Research, PLLC.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (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

Genders Eligible for Study:   Both
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) (5, 27) 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 (5, 27) are indicative of CTS. Borderline CSA measurements would require wrist forearm ratio (WFR) measurements to be a WFR > 1.5 (5, 36). 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070302

Contacts
Contact: Amanda Santimaw, MS 480-626-6653 amanda.santimaw@azarthritis.com
Contact: Benjamin Sucher, DO 480-443-8400 drsucher@msn.com

Locations
United States, Arizona
Arizona Arthritis & Rheumatology Not yet recruiting
Phoenix, Arizona, United States, 85032
Contact: Amanda Santimaw, MS    480-626-6653    amanda.santimaw@azarthritis.com   
Contact: Benjamin Sucher, DO    480-443-8400    drsucher@MSN.COM   
Principal Investigator: Benjamin Sucher, DO         
Sponsors and Collaborators
Benjamin Sucher
Allergan
Investigators
Principal Investigator: Benjamin Sucher, DO Arizona Arthritis & Rheumatology Research
  More Information

No publications provided

Responsible Party: Benjamin Sucher, Principal Investigator, Arizona Arthritis & Rheumatology Research, PLLC.
ClinicalTrials.gov Identifier: NCT02070302     History of Changes
Other Study ID Numbers: 85700, 85700
Study First Received: February 20, 2014
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
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, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014