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

Primary Purpose

Carpal Tunnel Syndrome

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Botulinum Toxin Type A

Placebo

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arizona Arthritis & Rheumatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Botulinum Toxin Type A

Placebo

Arm Description

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)

.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)

Outcomes

Primary Outcome Measures

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.

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

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.

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

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02070302

First Posted

February 20, 2014

Last Updated

September 22, 2017

Sponsor

Benjamin Sucher

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02070302

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Benjamin Sucher

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carpal Tunnel Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum Toxin Type A

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

.4cc/muscle of Normal saline will be injected into two injection sites each into Opponens Pollicis (OP) and the Abductor Pollicis Brevis (APB)

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A

Other Intervention Name(s)

Botox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Normal Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline Levine Symptom Severity Scale Status at Weeks 6, 12,18.

Description

Patients with Levine score < 4 were included in the study. The score for this assessment can range from 11-55.

Time Frame

Baseline-Week 18

Title

Change From Baseline Levine Function Severity Scale Status at Weeks 6, 12,18.

Description

Patients with Levine score of < 4 were included in the study. The score for this assessment can range from 8-40

Time Frame

Baseline-Week 18

Title

Change From Baseline in Median Nerve Compression on Neuromuscular Ultrasound at Week 6, Week 12, and Week 18.

Description

Neuromuscular ultrasound measures nerve compression (swelling) by cross sectional area of median nerve, in format % change from baseline.

Time Frame

Baseline to Week 18

Title

Change From Baseline Electrodiagnostics Distal Sensory Median Nerve Latency at Week 6, Week 12, and Week 18.

Description

Latency is the interval between the stimulation of a muscle and the observed response, measuring conduction speed in milliseconds compared to baseline

Time Frame

Baseline, week 6, week 12, and week 18.

Title

Change From Baseline Electrodiagnostics Motor Median Nerve Latency at Week 6, Week 12, and Week 18.

Description

Latency is the interval between the stimulation of a muscle and the observed response measuring nerve conduction speed in milliseconds.

Time Frame

Baseline to Week 18

Title

Change From Baseline Jamar Pinch (Unrelated Dominant Hand - Mean Value of All Repetitions/Positions) at Weeks 6, 12,18.

Description

Mean value of one finger and two finger opposition pinch between 1st and 5th and 1st with 4th and 5th phalanges.

Time Frame

Baseline-Week 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Sucher, DO

Organizational Affiliation

Arizona Arthritis & Rheumatology Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arizona Arthritis & Rheumatology

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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