Carpal Tunnel Syndrome Clinical Trial
NCT number | NCT01693094 |
Other study ID # | 2012P002281 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | June 10, 2014 |
Est. completion date | June 2026 |
Verified date | June 2023 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators plan a prospective randomized controlled study that compares the treatment decisions made by patients who receive decision aids, as compared to patients treated with usual care and the American Society for Surgery of the Hand brochures. The investigators expect to enroll 126 patients.
Status | Suspended |
Enrollment | 126 |
Est. completion date | June 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 and above - Diagnosis of moderate or severe: 2.) Carpal Tunnel Syndrome (CTS) 5.) Trigger Finger (TF) Exclusion Criteria: - Patients with previous interventions for CTS or TF - Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness). |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decision conflict scale (DCS) | Decision conflict scale (DCS) quantifies the state of uncertainty about a course of action. | At enrollment | |
Primary | Change from baseline in Decision conflict scale (DCS) at 6 weeks | Change from baseline in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action. | At 6-week follow-up | |
Primary | Change from baseline Decision conflict scale (DCS) at 6 months | 6-month Change in Decision conflict scale (DCS), which quantifies the state of uncertainty about a course of action. | At 6 month follow-up | |
Secondary | 11-point ordinal satisfaction scale | The 11-point ordinal satisfaction scale quantifies the satisfaction with overall treatment | At enrollment | |
Secondary | 11-point ordinal satisfaction scale | 11-point ordinal satisfaction scale quantifies the satisfaction with decision-making. | At enrollment | |
Secondary | Knowledge questionnaire | The knowledge questionnaire gauges patients' knowledge of their diagnosis and treatment options. | At Enrollment | |
Secondary | Stage of decision making | The Stage of decision making is meant to gauge patients' progress in making a treatment decision. | At Enrollment | |
Secondary | Decision Self-efficacy Scale | The Decision Self-Efficacy Scale measures patients' confidence in making treatment decisions. | At enrollment | |
Secondary | Acceptability | The Acceptability questionnaire measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making. |
At Enrollment | |
Secondary | Pain Self efficacy Questionnaire (PSEQ) | The PSEQ measures the efficacy of patients regarding pain. | At enrollment | |
Secondary | Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) | The Quick-DASH measures the patient's ability to do following activities in the week before a visit. | At enrollment | |
Secondary | EuroQol-5D-5L Questionnaire (EQ-5D-5L) | EQ-5D-5L measures the health outcome of the patient. | At Enrollment | |
Secondary | Decision Regret scale | The Decision Regret Scale measures distress or remorse after a health care decision. | At the 6-month follow-up | |
Secondary | Change from baseline in 11-point ordinal satisfaction scale at 6 weeks | 6-week change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment | At the 6 week follow-up | |
Secondary | Change from baseline in 11-point ordinal satisfaction scale at 6 months | 6-month change from baseline in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with overall treatment | At the 6 month follow-up | |
Secondary | Change from baseline in 11-point ordinal satisfaction scale at 6 weeks | 6-week change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making. | At the 6 week follow-up | |
Secondary | Change from baseline in 11-point ordinal satisfaction scale at 6 months | 6-month change in the 11-point ordinal satisfaction scale, which quantifies the satisfaction with decision-making. | At the 6 month follow-up | |
Secondary | Change from baseline in Stage of decision making at 6 weeks | 6-week change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision. | At the 6 week follow-up | |
Secondary | Change from baseline in Stage of decision making at 6 months | 6-month change in the Stage of decision making, which is meant to gauge patients' progress in making a treatment decision. | At the 6 week follow-up | |
Secondary | Change from baseline in the Knowledge questionnaire at 6 weeks | 6-week change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options. | At the 6 week follow-up | |
Secondary | Change from baseline in the Knowledge questionnaire at 6 months | 6-month change in the knowledge questionnaire, which gauges patients' knowledge of their diagnosis and treatment options. | At the 6 month follow-up | |
Secondary | Change from baseline in the Decision Self-efficacy Scale at 6 weeks | 6-week change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions. | At the 6 week follow-up | |
Secondary | Change from the baseline in the Decision Self-Efficacy Scale at 6 months | 6-month change in the Decision Self-Efficacy Scale, which measures patients' confidence in making treatment decisions. | At the 6 month follow-up | |
Secondary | Change from the baseline in the Acceptability questionnaire at 6 weeks | 6-week change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making. |
At the 6-week follow-up | |
Secondary | Change from the baseline in the Acceptability questionnaire at 6 months | 6-month change in the Acceptability questionnaire, which measures the acceptability of the decision aid, including the content of the decision aid.
It refers to ratings regarding the comprehensibility of components of a decision aid, its length, amount of information, balance in presentation of information about options, and overall suitability for decision making. |
At the 6 month follow-up | |
Secondary | Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 weeks | 6-week change in the PSEQ, which measures the efficacy of patients regarding pain. | At the 6 week follow-up | |
Secondary | Change in the baseline in the Pain Self efficacy Questionnaire (PSEQ) at 6 months | 6-month change in the PSEQ, which measures the efficacy of patients regarding pain. | At the 6 month follow-up | |
Secondary | Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 weeks | 6-week change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit. | At the 6 week follow-up | |
Secondary | Change from the baseline in the Disabilities of the Arm, Shoulder and Hand Quick Questionnaire (Quick-DASH) at 6 months | 6-month change in the Quick-DASH, which measures the patient's ability to do following activities in the week before a visit. | At the 6 month follow-up | |
Secondary | Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 weeks | 6-week change in the EQ-5D-5L, which measures the health outcome of the patient. | At the 6 week follow-up | |
Secondary | Change from the baseline in the EuroQol-5D-5L Questionnaire (EQ-5D-5L) at 6 months | 6-month change in the EQ-5D-5L, which measures the health outcome of the patient. | At the 6 month follow-up | |
Secondary | Change in the Decision Regret scale at 6 months | Change in the Decision Regret Scale, which measures distress or remorse after a health care decision. | At the 6 month follow-up |
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