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Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

Primary Purpose

Carpometacarpal Sprain, Thumb Sprain, Clostridium; Botulinum

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin
Standard-of-care corticosteroid injections
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpometacarpal Sprain focused on measuring Botulinum toxin, Carpometacarpal joint arthritis

Eligibility Criteria

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

Inclusion Criteria: Adult patients (> 18 years old) with a diagnosis of thumb CMC OA Diagnosis of thumb CMC OA History, clinical exam, and radiographic findings, as done in prior studies on this topic. Subjective: thumb or wrist pain at rest or with activity, joint stiffness Exam: basal joint tenderness, decreased mobility, deformity, instability Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage. Failed conservative management with oral pain medication and splinting for at least 3 months. Exclusion Criteria: Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc) Prior significant hand trauma related to the thumb or first CMC joint Prior intervention or hand surgery Patients with fibromyalgia or complex regional pain syndrome (CRPS) Pregnant and breastfeeding patients will also be excluded. We also will exclude individuals attempting to conceive or who could become pregnant within 6-months of treatment.

Sites / Locations

  • 235 Plain StreetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Botulinum Toxin

Arm Description

Patients in this group will receive standard-of-care corticosteroid injections.

Patients in this group will receive a Botulinum Toxin injection.

Outcomes

Primary Outcome Measures

Thumb Pain
The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.

Secondary Outcome Measures

Grip Strength
Secondary outcomes will include grip strength measured by asking a patient to compress a Jamar hydraulic hand dynamometer with maximal exertion at 2 seconds. This will be performed 3 times in each hand, alternating between the study hand and the contralateral hand, in order to provide rest between attempts and establish a baseline for the unaffected or less affected hand. The average of 3 values for each hand will be computed and recorded. In a similar fashion, key pinch strength will be measured using a pinch dynamometer.
Thumb range of motion
Thumb range of motion (ROM) will be measured for the basal joint: (1) in-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal, with the apex centered over the scaphoid when the hand is placed flat upon the exam table, (2) out-of-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal bones when the dorsum of the hand is placed flat upon the exam table and the patient is asked to point their thumb vertically toward the ceiling; (3) metacarpophalangeal (MCP) values will consist of measurement of the angle between the axis of the metacarpal and proximal phalangeal bones of the first digit, as means of assessing laxity in the adjacent joint, which is commonly increased as a sequelae of basilar joint arthritis.

Full Information

First Posted
July 24, 2023
Last Updated
August 10, 2023
Sponsor
Rhode Island Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05990881
Brief Title
Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis
Official Title
Botulinum Toxin Injection in the Management of Thumb Carpometacarpal Arthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 27, 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to gather information on the safety and effectiveness of botulinum toxin injection (or Botox) in the treatment of thumb joint pain/arthritis. People with thumb joint pain or arthritis usually receive steroid injections to help with the pain. However, this medicine does not always work well and also carries known important side effects. There is currently no alternative to this injection medicine. This clinical trial seeks to investigate botulinum toxin as a possible alternative to steroid injection. The difference between Botox and steroid injections is that they are different medicines and work in different ways. Botox, as it is being used in this study, is not FDA-approved. It is therefore considered an investigational medicine.
Detailed Description
Thumb carpometacarpal (CMC) osteoarthritis (OA) is one of the most common conditions treated by hand surgeons in the US. The treatment algorithm includes a stepwise strategy starting with conservative management and escalating to operative interventions when nonoperative measures fail to control pain or there is progression to a painful joint. Intra-articular injection of steroids represents a mainstay in the treatment approach for patients with thumb CMC OA, but despite its ubiquity, the American College of Rheumatology only conditionally recommends steroid injections due to a lack of evidence. Additionally, steroid injections carry significant risks, including the possibility of tissue atrophy, skin hypopigmentation, and joint arthropathy. As a result, alternative means have been sought to better treat pain and potentially delay the need for surgery. Botulinum toxin (BoNT) may be one such alternative. BoNT is produced by Clostridium botulinum and exerts temporary neuromodulation by rapidly and strongly binding to presynaptic cholinergic nerve terminals. BoNT has also been shown to inhibit the secretion of pain mediators from the nerve endings of the dorsal root ganglia, reduce local inflammation around nerve endings, deactivate sodium channels, and perform retrograde axonal transport. Due to the growing evidence of efficacy in treating neuropathic pain, the use of BoNT has become incorporated in the management of chronic migraines, trigeminal neuralgia, spinal cord injuries, and post-stroke pain syndrome. Additionally, intra-articular BoNT injections were shown to decrease pain in patients with knee and shoulder refractory arthritis. The investigators propose that intra-articular BoNT injections may decrease pain in patients with thumb CMC OA through the chemical denervation of articular pain fibers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpometacarpal Sprain, Thumb Sprain, Clostridium; Botulinum
Keywords
Botulinum toxin, Carpometacarpal joint arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
There will be two groups to which patients will be randomized: the control group, in which patients will receive the standard treatment for carpometacarpal joint arthritis (i.e., corticosteroid injection), and the experimental group, in which patients receive Botulinum toxin injection.
Masking
Participant
Masking Description
Patients will not be informed of which group they are assigned. A small bandage will be placed over the injection site after the injection is performed since corticosteroid injections may cause mild, benign skin discoloration.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients in this group will receive standard-of-care corticosteroid injections.
Arm Title
Botulinum Toxin
Arm Type
Experimental
Arm Description
Patients in this group will receive a Botulinum Toxin injection.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Other Intervention Name(s)
Botox
Intervention Description
Patients in this group will receive an injection of Botulinum toxin.
Intervention Type
Drug
Intervention Name(s)
Standard-of-care corticosteroid injections
Intervention Description
Patients in this group will receive an injection of corticosteroid injections, which are considered standard of care.
Primary Outcome Measure Information:
Title
Thumb Pain
Description
The primary outcome of interest is an improvement of thumb-specific pain scored by a change in the visual analog scale (VAS) pain score. VAS was chosen based on strong evidence supporting its validity in assessing pain in patients with OA. VAS will be measured by asking patients to make a vertical mark on a 10-cm horizontal line with 0 (far-left hash mark) representing no pain and 10 (far-right hash mark) representing the worst pain of their life. Scores will be quantified by measuring the difference in the distance from the left hash mark to the patient's mark in millimeters using a caliper. Based on the literature, the minimal clinically important difference (MCID) for VAS is 1.6 cm and 2.2 cm for substantial clinical benefit (SCB). Pre-injection VAS scores will be taken to first establish a baseline.
Time Frame
Post-injection VAS scores will then be taken at each subsequent follow-up visit: 2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Secondary Outcome Measure Information:
Title
Grip Strength
Description
Secondary outcomes will include grip strength measured by asking a patient to compress a Jamar hydraulic hand dynamometer with maximal exertion at 2 seconds. This will be performed 3 times in each hand, alternating between the study hand and the contralateral hand, in order to provide rest between attempts and establish a baseline for the unaffected or less affected hand. The average of 3 values for each hand will be computed and recorded. In a similar fashion, key pinch strength will be measured using a pinch dynamometer.
Time Frame
2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).
Title
Thumb range of motion
Description
Thumb range of motion (ROM) will be measured for the basal joint: (1) in-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal, with the apex centered over the scaphoid when the hand is placed flat upon the exam table, (2) out-of-plane thumb abduction values represent the angle (in degrees) between the axis of the first and second metacarpal bones when the dorsum of the hand is placed flat upon the exam table and the patient is asked to point their thumb vertically toward the ceiling; (3) metacarpophalangeal (MCP) values will consist of measurement of the angle between the axis of the metacarpal and proximal phalangeal bones of the first digit, as means of assessing laxity in the adjacent joint, which is commonly increased as a sequelae of basilar joint arthritis.
Time Frame
2-weeks, 1-month, 6-months, and 1-year (primary study endpoint).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (> 18 years old) with a diagnosis of thumb CMC OA Diagnosis of thumb CMC OA History, clinical exam, and radiographic findings, as done in prior studies on this topic. Subjective: thumb or wrist pain at rest or with activity, joint stiffness Exam: basal joint tenderness, decreased mobility, deformity, instability Radiograph: joint space narrowing, subchondral sclerosis, osteophytes, subchondral cysts, Eaton-Littler stage. Failed conservative management with oral pain medication and splinting for at least 3 months. Exclusion Criteria: Severe osteoarthritis (Eaton-Littler stage 4) or too large osteophytes to allow for injection into the joint space Inflammatory arthritis Any concomitant hand conditions (i.e. carpal tunnel, trigger finger, etc) Prior significant hand trauma related to the thumb or first CMC joint Prior intervention or hand surgery Patients with fibromyalgia or complex regional pain syndrome (CRPS) Pregnant and breastfeeding patients will also be excluded. We also will exclude individuals attempting to conceive or who could become pregnant within 6-months of treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loree K Kalliainen, MD
Phone
6127082517
Email
lkkllnn@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Vinay Rao, MD
Phone
8133856534
Email
vinayrao33@gmail.com
Facility Information:
Facility Name
235 Plain Street
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loree K Kalliainen, MD
Phone
612-708-2517
Email
lkkllnn@gmail.com
First Name & Middle Initial & Last Name & Degree
Elijah M Persad-Paisley, BA
Phone
3472353331
Email
elijahpp@brown.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
15252092
Citation
Haara MM, Heliovaara M, Kroger H, Arokoski JP, Manninen P, Karkkainen A, Knekt P, Impivaara O, Aromaa A. Osteoarthritis in the carpometacarpal joint of the thumb. Prevalence and associations with disability and mortality. J Bone Joint Surg Am. 2004 Jul;86(7):1452-7. doi: 10.2106/00004623-200407000-00013.
Results Reference
background
PubMed Identifier
29969109
Citation
Weiss AC, Goodman AD. Thumb Basal Joint Arthritis. J Am Acad Orthop Surg. 2018 Aug 15;26(16):562-571. doi: 10.5435/JAAOS-D-17-00374.
Results Reference
background
PubMed Identifier
31103085
Citation
Pickrell BB, Eberlin KR. Thumb Basal Joint Arthritis. Clin Plast Surg. 2019 Jul;46(3):407-413. doi: 10.1016/j.cps.2019.02.010.
Results Reference
background
PubMed Identifier
25776442
Citation
Trellu S, Dadoun S, Berenbaum F, Fautrel B, Gossec L. Intra-articular injections in thumb osteoarthritis: A systematic review and meta-analysis of randomized controlled trials. Joint Bone Spine. 2015 Oct;82(5):315-9. doi: 10.1016/j.jbspin.2015.02.002. Epub 2015 Mar 14.
Results Reference
background
PubMed Identifier
2011163
Citation
Jankovic J, Brin MF. Therapeutic uses of botulinum toxin. N Engl J Med. 1991 Apr 25;324(17):1186-94. doi: 10.1056/NEJM199104253241707. No abstract available.
Results Reference
background
PubMed Identifier
24715952
Citation
Singh JA. Use of botulinum toxin in musculoskeletal pain. F1000Res. 2013 Feb 15;2:52. doi: 10.12688/f1000research.2-52.v2. eCollection 2013.
Results Reference
background
PubMed Identifier
16112345
Citation
Cote TR, Mohan AK, Polder JA, Walton MK, Braun MM. Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases. J Am Acad Dermatol. 2005 Sep;53(3):407-15. doi: 10.1016/j.jaad.2005.06.011.
Results Reference
background

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Injection of Botulinum Toxin for Thumb Carpometacarpal Arthritis

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