An interventional study of Decision Aid and Toolkit for de Quervain's in De Quervain Disease, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
30 studies on the registry are indexed under De Quervain Disease; 7 are open to participants now.
This study's enrollment of 22 is below the median of 55 across 26 interventional studies indexed under De Quervain Disease.
Browse De Quervain Disease studies →Massachusetts General Hospital is the lead sponsor of 2,588 studies on the registry; 446 are open to participants now.
Of its 223 completed or terminated interventional studies of FDA-regulated products, 168 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants without symptoms of depression who have the opportunity to use a Decision Aid but otherwise receive Usual care
Other: Decision Aid
Participants with symptoms of depression who are randomized to receive Usual care (in addition to the Decision Aid)
Other: Decision Aid
Participants with symptoms of depression who are randomized to receive the Toolkit intervention in addition to Usual care
Other: Decision Aid · Behavioral: Toolkit for de Quervain's
A website that contains information about de Quervain's tenosynovitis and the options for treatment
A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis
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).
Time frame: 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).
Time frame: 6 months
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.
Time frame: 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).
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2018 to primary completion in Feb 2022, 38 months.
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This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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