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A Clinical Trial of Splinting for DeQuervain's Tenosynovitis

A Clinical Trial of Full Time vs. As Needed Splint Wear for DeQuervain's Tenosynovitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00438191
Enrollment
83
Registered
2007-02-22
Start date
2005-12-31
Completion date
2015-12-31
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DeQuervain's Tenosynovitis

Keywords

DeQuervain's tenosynovitis, splinting, grip strength, satisfaction, DASH questionnaire

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patient (age 18 years or greater) * Physician very confident about the diagnosis of DeQuervain's tenosynovitis.

Exclusion criteria

* Patients with previous history of surgical treatment for De Quervain's. * Skin conditions making splint wear problematic.

Design outcomes

Primary

MeasureTime frameDescription
Disabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire8 weeksThe DASH questionnaire measures upper extremity disability on a scale from 0-100, where 0 is no disability and 100 is severe disability.

Secondary

MeasureTime frameDescription
Grip Strength8 weeksGrip strength is measured as a percentage of the non-affected or least affected side.
Treatment Satisfaction8 weeksTreatment satisfaction was measured on a scale from 0-10, where 0 is complete dissatisfaction and 10 is complete satisfaction
Pain Intensity8 weeksPain 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
As-Desired Splinting
Subjects who wear the splint as desired
43
Full Time Splinting
Subjects who wear the splint as much as possible
40
Total83

Baseline characteristics

CharacteristicAs-Desired SplintingFull Time SplintingTotal
Age, Continuous49.93 years
STANDARD_DEVIATION 14.58
48.74 years
STANDARD_DEVIATION 13.9
49.26 years
STANDARD_DEVIATION 14.55
Center for Epidemiologic Studies Depression Scale - Revised (CES-D)16.3 units on a scale
STANDARD_DEVIATION 6.5
16.3 units on a scale
STANDARD_DEVIATION 8.7
16.3 units on a scale
STANDARD_DEVIATION 7.6
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire36.5 units on a scale
STANDARD_DEVIATION 19
33.3 units on a scale
STANDARD_DEVIATION 17.8
34.96 units on a scale
STANDARD_DEVIATION 18.4
Grip Strength54.1 percentage of non-affected hand
STANDARD_DEVIATION 22.9
58.6 percentage of non-affected hand
STANDARD_DEVIATION 18.7
56.3 percentage of non-affected hand
STANDARD_DEVIATION 21
Pain Catastrophizing scale (PCS)20.9 units on a scale
STANDARD_DEVIATION 8.7
17.5 units on a scale
STANDARD_DEVIATION 9.5
19.3 units on a scale
STANDARD_DEVIATION 9.2
Pain Intensity5.5 units on a scale
STANDARD_DEVIATION 2.3
5.8 units on a scale
STANDARD_DEVIATION 2.4
5.6 units on a scale
STANDARD_DEVIATION 2.4
Region of Enrollment
United States
43 participants40 participants83 participants
Sex: Female, Male
Female
36 Participants35 Participants71 Participants
Sex: Female, Male
Male
7 Participants5 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 430 / 40
other
Total, other adverse events
0 / 430 / 40
serious
Total, serious adverse events
0 / 430 / 40

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
As-Desired SplintingDisabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire28 units on a scaleStandard Deviation 15
Full Time SplintingDisabilities of the Arm, Shoulder, and Hand (DASH) Questionnaire29 units on a scaleStandard Deviation 20
Secondary

Grip Strength

Grip strength is measured as a percentage of the non-affected or least affected side.

Time frame: 8 weeks

ArmMeasureValue (MEAN)Dispersion
As-Desired SplintingGrip Strength86 percentage of non-affected handStandard Deviation 25
Full Time SplintingGrip Strength87 percentage of non-affected handStandard Deviation 18
Secondary

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

ArmMeasureValue (MEAN)Dispersion
As-Desired SplintingPain Intensity3.8 units on a scaleStandard Deviation 2
Full Time SplintingPain Intensity4.4 units on a scaleStandard Deviation 2.9
Secondary

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

ArmMeasureValue (MEAN)Dispersion
As-Desired SplintingTreatment Satisfaction6.3 units on a scaleStandard Deviation 2.6
Full Time SplintingTreatment Satisfaction6.4 units on a scaleStandard Deviation 2.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026