NCT03770091

Brief Summary

Thumb carpometacarpal osteoarthritis (CMC OA) affects up to 33% of people over the age of 40, which leads to inflammation, pain, and weakness of the CMC joint. Treatment modalities are both conservative and surgical with surgical options including osteotomy, bone excision, ligament reconstruction, and various prosthetic implants. The conservative treatment options, however, are limited to NSAIDs and bracing or steroid injections. Advances in topical therapies have the potential to deliver focused treatment to the CMC joint. Novel treatment of inflammation can potentially reduce inflammation and pain associated with progressing osteoarthritis. Theraworx Relief is an FDA registered foam that has theoretical impact on inflammation reduction in human subjects treated with the topical foam.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 14, 2021

Completed
Last Updated

July 14, 2021

Status Verified

July 1, 2021

Enrollment Period

1.6 years

First QC Date

December 6, 2018

Results QC Date

June 12, 2021

Last Update Submit

July 13, 2021

Conditions

Arthritis

Outcome Measures

Primary Outcomes (5)

  • Numeric Pain Rating Scale

    patient rated pain on scale of 0-10 (0 no pain and 10 maximum pain). The mean score at 2 weeks is reported, not the change from baseline.

    2 weeks

  • Disabilities of the Arm, Shoulder, and Hand (DASH) Score

    patient rated outcome score on scale of 0-100, with 0 being no disability and 100 complete disability, mean value at 2 weeks is reported

    2 weeks

  • Thumb Range of Motion

    This measures range of motion of the thumb in degrees from 0-90 degrees (0 degrees would be no motion and 90 degrees full motion), 2 week data is presented as a mean.

    2 weeks

  • Grip Strength

    This measures grip strength in pounds (0 is no grip strength 150 is maximum grip strength), mean grip strength in pounds reported at 2 weeks

    2 weeks

  • Pinch Strength

    This measures pinch strength in pounds (0 is no pinch strength and 40 is maximum pinch strength), mean pinch in pounds reported at 2 weeks

    2 weeks

Study Arms (3)

Foam and Compression Wrap

EXPERIMENTAL

Patients will use Theraworx foam and a compression wrap

Drug: Theraworx

Placebo Foam and Compression Wrap

PLACEBO COMPARATOR

Patients will use placebo foam and a compression wrap

Drug: Placebo

Foam alone

EXPERIMENTAL

Patients will use Theraworx foam without compression wrap

Drug: Theraworx

Interventions

TheraworxDRUG

Theraworx foam applied to skin and/or compression wrap

Foam aloneFoam and Compression Wrap
PlaceboDRUG

Placebo foam

Placebo Foam and Compression Wrap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thumb CMC arthritis
  • greater than or equal to age 18
  • Interested in non-operative treatment of thumb arthritis

You may not qualify if:

  • Recent corticosteroid injection into the thumb joint
  • Non-English speaking
  • skin lesions or rashes on the thumb
  • current use of topical anti-inflammatory medications
  • concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
  • known allergy to magnesium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaufmann Building

Pittsburgh, Pennsylvania, 15213, United States

Location

Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Results Point of Contact

Title
John Fowler
Organization
UPMC
fowlerjr@upmc.edu
412-605-3245

Study Officials

  • John R Fowler, MD

    Univ. of Pittsburgh Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 10, 2018

Study Start

December 21, 2018

Primary Completion

July 30, 2020

Study Completion

August 1, 2020

Last Updated

July 14, 2021

Results First Posted

July 14, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)