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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070302
• Other study ID #: 85700
• Secondary ID: 85700
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2014
• Last updated: September 22, 2017
• Start date: October 2014
• Est. completion date: February 2016

Study information

• Verified date: August 2017
• Source: Arizona Arthritis & Rheumatology Research, PLLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Botulinum Toxin Type A
40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
• Placebo
Placebo (Normal Saline) divided into 2 injections of .4cc each

Locations

Country	Name	City	State
United States	Arizona Arthritis & Rheumatology	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Benjamin Sucher	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.	Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.	Baseline-Week 18
Primary	Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.	Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40	Baseline-Week 18
Primary	Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.	Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.	Baseline to Week 18
Primary	Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at 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.
Primary	Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and 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
Primary	Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.	Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.	Baseline-Week 18