An observational study in DeQuervain's Tenosynovitis, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by Massachusetts General Hospital · Observational
DeQuervain's tenosynovitis is characterized by pain on the pain on the radial (thumb) side of the wrist problems with thumb function. At this point, the standard care is to change daily activities, use a thumb brace, and the possible use of painkillers. There is a difference in opinion among physical therapists about how to use the splint in the treatment of DeQuervain tenosynovitis. Some physicians tell patients to wear the brace at all times while other therapists encourage patients to exercise and use the brace as needed. Both approaches to using the splint are accepted as standard. The purpose of this study is to test and evaluate these two ways of splinting and assess which one is better for patients with DeQuervain tenosynovitis.
De Quervain's tenosynovitis (stenosing tenosynovitis of the first dorsal extensor compartment) is characterized by pain on the radial (thumb) side of the wrist and impairment of thumb and wrist function. Histological evaluation is consistent with a chronic rather than an acute tenosynovitis consistent with the often prolonged course of this disease.
Nonoperative treatments include modification of activities, splint immobilization, icing and anti-inflammatory medication, and corticosteroid injections. Long opponens splinting (or short arm thumb spica splinting; a splint that immobilizes the wrist and the thumb) is standard and well accepted. There is no consensus on the best protocol for use of the splint. Some authors advocate full time splinting for 4 - 6 weeks, with the rationale that tendonitis will resolve with strict rest. Other authors, perhaps aware of histological evidence that De quervain's is a chronic rather than acute inflammatory condition, feel that the splint serves merely to relieve symptoms and is best used as best suits each individual patient. To our knowledge, there are not data available regarding these disparate views.
The ultimate prognosis for recovery in the condition seems satisfying, regardless of the treatment, and spontaneous recovery is the rule. Psychological and personality factors, such as pain anxiety, catastrophizing, and depression are strongly related to upper extremity specific health status and may also influence recovery.
The primary goal of this study is to determine which protocol of splinting leads to better outcome in non-surgical treatment of DeQuervain's tenosynovitis. As a secondary goal and to generate hypotheses for later studies we would like to evaluate the influence of psychosocial factors on both objective (grip strength) and subjective (DASH questionnaire) measures of outcome.
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This study's enrollment of 83 is below the median of 180 across 115 observational studies indexed under Personal Satisfaction.
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Patients from the MGH Hand and Upper Extremity Service.
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Exclusion Criteria:
Subjects who wear the splint whenever the feel the need.
Subjects who wear the splint whenever possible.
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire
The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.
Time frame: 8 weeks
Grip Strength
Grip strength is measured as a percentage of the non-affected or least affected side.
Time frame: 8 weeks
Treatment Satisfaction
Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
Time frame: 8 weeks
Pain Intensity
Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.
Time frame: 8 weeks
| Milestone | As-Desired Splinting | Full Time Splinting |
|---|---|---|
| Started | 43 | 40 |
| Completed | 32 | 26 |
| Not completed | 11 | 14 |
The DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.
| units on a scale | As-Desired Splinting | Full Time Splinting |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire | 28 ± 15 | 29 ± 20 |
Grip strength is measured as a percentage of the non-affected or least affected side.
| percentage of non-affected hand | As-Desired Splinting | Full Time Splinting |
|---|---|---|
| Grip Strength | 86 ± 25 | 87 ± 18 |
Treatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
| units on a scale | As-Desired Splinting | Full Time Splinting |
|---|---|---|
| Treatment Satisfaction | 6.3 ± 2.6 | 6.4 ± 2.9 |
Pain intensity was measured using the Numeric Rating Scale, on a scale from 0-10, where 0 is no pain and 10 is the most pain.
| units on a scale | As-Desired Splinting | Full Time Splinting |
|---|---|---|
| Pain Intensity | 3.8 ± 2.0 | 4.4 ± 2.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| As-Desired Splinting | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Full Time Splinting | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 49.93 ± 14.58 | 48.74 ± 13.90 | 49.26 ± 14.55 |
| Sex: Female, Male(Participants) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Female | 36 | 35 | 71 |
| Male | 7 | 5 | 12 |
| Region of Enrollment(participants) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| United States | 43 | 40 | 83 |
| Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire(units on a scale) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 36.5 ± 19.0 | 33.3 ± 17.8 | 34.96 ± 18.40 |
| Pain Intensity(units on a scale) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 5.5 ± 2.3 | 5.8 ± 2.4 | 5.6 ± 2.4 |
| Center for Epidemiologic Studies Depression Scale - Revised (CES-D)(units on a scale) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 16.3 ± 6.5 | 16.3 ± 8.7 | 16.3 ± 7.6 |
| Pain Catastrophizing scale (PCS)(units on a scale) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 20.9 ± 8.7 | 17.5 ± 9.5 | 19.3 ± 9.2 |
| Grip Strength(percentage of non-affected hand) | As-Desired Splinting | Full Time Splinting | Total |
|---|---|---|---|
| Mean | 54.1 ± 22.9 | 58.6 ± 18.7 | 56.3 ± 21.0 |
The record gives a start of Dec 2005, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 1 year 6 months after primary completion.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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