NCT04069741

Brief Summary

This study evaluates a Decision Aid to help patients with de Quervain's tenosynovitis decide how to treat their condition. For patients with symptoms of depression, half the participants will receive a psychological intervention (Toolkit) to improve depression and pain from de Quervain's tenosynovitis. The investigators hypothesize that both the Decision Aid and the Toolkit will be feasible, and that the Toolkit will improve pain and function compared to usual care.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2022

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

August 16, 2019

Last Update Submit

April 29, 2022

Conditions

De Quervain Disease

Outcome Measures

Primary Outcomes (2)

  • QuickDASH score (Disabilities of the Arm Shoulder and Hand)

    This questionnaire measures individual's ability to complete daily tasks and the severity of their symptoms. The scoring scale ranges from 0 (no disability) to 100 (most severe disability).

    6 months

  • Numerical Pain Rating Scale

    This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).

    6 months

Secondary Outcomes (2)

  • Patient Health Questionnaire 9

    6 months

  • Pain Catastrophizing Scale

    6 months

Study Arms (3)

Usual care, no depression

OTHER

Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care

Other: Decision Aid

Usual care, depression

OTHER

Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)

Other: Decision Aid

Toolkit, depression

ACTIVE COMPARATOR

Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care

Other: Decision AidBehavioral: Toolkit for de Quervain's

Interventions

Decision AidOTHER

A website that contains information about de Quervain's tenosynovitis and the options for treatment

Toolkit, depressionUsual care, depressionUsual care, no depression
Toolkit for de Quervain'sBEHAVIORAL

A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis

Toolkit, depression

Eligibility Criteria

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

You may qualify if:

  • Adults (≥18 years) diagnosed with de Quervain's tenosynovitis
  • English fluency and literacy
  • Ability to give informed consent

You may not qualify if:

  • Inability or unwillingness to participate in decision aid (DA) and/or Toolkit-depression
  • Major medical comorbidity expected to worsen in the next 6 months
  • Comorbid chronic pain condition
  • Antidepressant medications changes in the past 6 months
  • Severe and untreated mental health conditions or active substance dependence
  • Secondary gains such as litigations or worker compensation procedures that may interfere with patients' motivation for treatment
  • No online device available to use the DA and Toolkit-depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hand and Arm Center, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

De Quervain Disease

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Neal C Chen, MD

    Hand and Arm Center Lead, Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Ana-Maria Vranceanu, PhD

    IBHCRP, Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interim Chief of the Hand & Arm Center

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 28, 2019

Study Start

December 10, 2018

Primary Completion

February 19, 2022

Study Completion

February 19, 2022

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)