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Data difficult to collect due to the COVID-19 pandemic.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care, no depression | Other | Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care |
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| Usual care, depression | Other | Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid) |
|
| Toolkit, depression | Active Comparator | Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other | A website that contains information about de Quervain's tenosynovitis and the options for treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal C Chen, MD | Hand and Arm Center Lead, Massachusetts General Hospital | Principal Investigator |
| Ana-Maria Vranceanu, PhD | IBHCRP, Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hand and Arm Center, Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 | Apr 25, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D053684 | De Quervain Disease |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Randomized Controlled Trial
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| Toolkit for de Quervain's | Behavioral | A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis |
|
| 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). | 6 months |