De Quervain DiseaseNCT04069741
Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
A study testing Decision Aid and Toolkit for de Quervain's in people with De Quervain Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- De Quervain Disease
- What is being tested?
- Decision Aid and Toolkit for de Quervain's
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2018to 19 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) diagnosed with de Quervain's tenosynovitis
- English fluency and literacy
- Ability to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hand and Arm Center, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
The investigators are doing this research to see if they can improve the management of patients with de Quervain's tendinopathy. In the first part of this study, a Decision Aid (DA) has been developed to help participants make choices about their treatment.
Decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. Research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using DAs.
Additionally, research has shown that depression affects pain and disability experienced by patients with de Quervain's tenosynovitis. In the second part of our study, the investigators want to see whether a web based skills intervention (Toolkit) is more effective than usual medical care in improving pain and disability in patients with de Quervain's tenosynovitis and symptoms of depression.
The Toolkit is delivered online and can be accessed at home. Similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.
- Conditions
- De Quervain Disease
- Being tested
- Decision Aid, Toolkit for de Quervain's
- Medical subject headings
- De Quervain Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
A website that contains information about de Quervain's tenosynovitis and the options for treatment
Toolkit for de Quervain'sBehavioural
A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis
| Study group | Role | What they receive |
|---|---|---|
| Usual care, no depression | Other | Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care Receives: 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) Receives: 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 Receives: Other: Decision Aid; Behavioral: Toolkit for de Quervain's |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (2)
Patient Health Questionnaire 9
This questionnaire is used for screening and measuring the severity of depression. The scale ranges from 0 to 27 overall. A score between the range of 5-9 indicates minimal symptoms of depression. A score between 10-14 suggests minimal depression or mild, major depression. A range of 15-19 indicates moderately severe, major depression, and a score of greater than 20 suggests severe, major depression.
Measured: 6 months
Pain Catastrophizing Scale
This scale measures the individual's level of catastrophic thinking related to pain. They are asked about the thoughts and feelings they have when experiencing pain. The responses range from 0 (not at all) to 4 (all the time). The total score ranges from O-52. There are three subscale scores that assess rumination, magnification, and helplessness. The helplessness score ranges from 0 (not helpless) to 24 (severe helplessness). The rumination score ranges from 0 (don't think about the pain) to 16 (constantly think about how much it hurts). The magnification score ranges from 0 (does not feel like the pain is or will be more serious) to 12 (thinks the pain will get more serious).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Dec 2018
- Primary completion19 Feb 2022
- Study completion19 Feb 2022
Why it stopped: Data difficult to collect due to the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for De Quervain DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal C Chen, MD, Principal investigator, Hand and Arm Center Lead, Massachusetts General HospitalAna-Maria Vranceanu, PhD, Principal investigator, IBHCRP, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069741
- Sponsor's protocol ID
- 2018P002064
- Status last verified
- Apr 2022
- First submitted
- 16 Aug 2019
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Depression in Patients With De Quervain's Tenosynovitis; An Integrated Web Based Skills Intervention
- ClinicalTrials.gov ID
- NCT04069741
- Acronym / sponsor ID
- 2018P002064
- Conditions
- De Quervain Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data difficult to collect due to the COVID-19 pandemic.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators are doing this research to see if they can improve the management of patients with de Quervain's tendinopathy. In the first part of this study, a Decision Aid (DA) has been developed to help participants make choices about their treatment.
Decision aids are designed to provide patients with balanced, complete, and understandable information about their options for management of their condition, as well as risks and benefits, in order to help them determine their preferences according to their values. Research has shown that patients felt more knowledgeable and better informed with a more active role in decision making after using DAs.
Additionally, research has shown that depression affects pain and disability experienced by patients with de Quervain's tenosynovitis. In the second part of our study, the investigators want to see whether a web based skills intervention (Toolkit) is more effective than usual medical care in improving pain and disability in patients with de Quervain's tenosynovitis and symptoms of depression.
The Toolkit is delivered online and can be accessed at home. Similar skills interventions in patients with musculoskeletal injury have been shown to improve pain and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Usual care, no depression | Other | Other: Decision AidParticipants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care |
| Usual care, depression | Other | Other: Decision AidParticipants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid) |
| Toolkit, depression | Active comparator | Other: Decision Aid, Behavioral: Toolkit for de Quervain'sParticipants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) diagnosed with de Quervain's tenosynovitis
- English fluency and literacy
- Ability to give informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidA website that contains information about de Quervain's tenosynovitis and the options for treatment | Other | Toolkit, depression, Usual care, depression, Usual care, no depression |
| Toolkit for de Quervain'sA website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis | Behavioural | Toolkit, depression |
Primary outcome
QuickDASH score (Disabilities of the Arm Shoulder and Hand)
Time frame: 6 months
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).
Numerical Pain Rating Scale
Time frame: 6 months
This scale measures the patient's pain intensity. The scale ranges from 0 (no pain) to 10 (worst possible pain).
2 secondary outcomes
Patient Health Questionnaire 9
Time frame: 6 months
Pain Catastrophizing Scale
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Data difficult to collect due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
Related trials for De Quervain Disease
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Not yet recruiting
Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test
Non-traumatic Musculoskeletal Conditions, Carpal Tunnel Syndrome (CTS)
RecruitingPhase 4
Ketorolac in Upper Extremity Tendinopathy and Arthropathy
Osteoarthritis, Tendinopathy
Not yet recruitingPhase 2
NAC-REPAIR for Post-surgical Pain
Carpal Tunnel Surgery, Trigger Finger Disorder
RecruitingPhase 4
Intra-sheath vs Extra-sheath Injection for De Quervain's Tenosynovitis
De Quervain Tenosynovitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal C Chen, MD principal investigator
Hand and Arm Center Lead, Massachusetts General Hospital
Ana-Maria Vranceanu, PhD principal investigator
IBHCRP, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid and Toolkit for de Quervain's in people with De Quervain Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Data difficult to collect due to the COVID-19 pandemic.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH score (Disabilities of the Arm Shoulder and Hand) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.