Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00438191
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2007-02-20
Brief Title:
A Clinical Trial of Splinting for DeQuervains Tenosynovitis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Clinical Trial of Full Time vs As Needed Splint Wear for DeQuervains Tenosynovitis
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
DeQuervains 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 Quervains 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 quervains 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 DeQuervains 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
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 quervains 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 DeQuervains 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None