Skip to main content
OpenTrials
Completed

NCT Number: NCT02070302

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arizona Arthritis & Rheumatology

Phoenix, Arizona, 85032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum Toxin Type A

Drug

40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each

Other names: Botox

Placebo

Drug

Placebo (Normal Saline) divided into 2 injections of .4cc each

Other names: Normal Saline

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Benjamin Sucher

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2014
Registry last updated
Sep 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.