Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000394
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
1999-11-03
Brief Title:
Acupuncture for Carpal Tunnel Syndrome
Sponsor:
George Washington University
Organization:
George Washington University
Study Overview
Official Title:
A Controlled Trial of Acupuncture for Carpal Tunnel Syndrome
Status:
COMPLETED
Status Verified Date:
2000-06
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:
This study will look at the effectiveness of acupuncture for treating carpal tunnel syndrome CTS People who participate in this study will have CTS that has been diagnosed by physical examination and neurological testing We will randomly assign study participants to receive one of the three types of acupuncture either once twice or three times weekly for a total of 6 weeks Acupuncturists will treat one group of patients with true acupuncture They will give the other two groups of patients one of two alternative acupuncture treatments that do not use the true acupuncture points The patients and evaluators will not know the type of acupuncture True Alternative 1 or Alternative 2 that is being used The acupuncturists will not communicate with the patients and will not be involved in patient evaluation
Detailed Description:
This is a randomized double-blind controlled trial of acupuncture for carpal tunnel syndrome CTS The studys aims are 1 To show that we can develop a single-blind mute methodology that will enable true and alternative acupuncture to be given in a standardized and unbiased fashion 2 To identify and standardize the most appropriate invasive control alternative acupuncture points for CTS 3 To develop a manual of acupuncture methods that codifies the techniques of administration of true and alternative points that can be used at any site performing a randomized clinical trial for CTS 4 To demonstrate that patient recruitment for and retention in a small short-term randomized controlled trial RCT of acupuncture for CTS is sufficient to justify a full-scale RCT 5 To determine in an RCT whether true acupuncture provides meaningful benefit for pain in CTS compared to alternative acupuncture and whether the frequency of administration of acupuncture influences the outcome
The patients and evaluators will be blinded as to the type of acupuncture True Alternative 1 or Alternative 2 The acupuncturists will not be blinded but will be mute noncommunicative to the patients and will not be involved in patient evaluation Patients will have clinically and electrodiagnostically proven CTS They will be randomized to receive one of the three types of acupuncture either once twice or three times weekly for 6 weeks total three by three design Our aim is to recruit 144 patients for this study The primary outcome measure will be a validated CTS Symptom Severity Scale at 2 weeks after the last acupuncture treatment We will evaluate patients 10 weeks later to determine the durability of any improvement from acupuncture Other outcome measures include subjective symptoms functional status analgesic consumption frequencyduration of splinting and effect on median nerve conduction velocity
The patients and evaluators will be blinded as to the type of acupuncture True Alternative 1 or Alternative 2 The acupuncturists will not be blinded but will be mute noncommunicative to the patients and will not be involved in patient evaluation Patients will have clinically and electrodiagnostically proven CTS They will be randomized to receive one of the three types of acupuncture either once twice or three times weekly for 6 weeks total three by three design Our aim is to recruit 144 patients for this study The primary outcome measure will be a validated CTS Symptom Severity Scale at 2 weeks after the last acupuncture treatment We will evaluate patients 10 weeks later to determine the durability of any improvement from acupuncture Other outcome measures include subjective symptoms functional status analgesic consumption frequencyduration of splinting and effect on median nerve conduction velocity
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-003 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AR045894 |
| R01AR045894 | NIH | None | None |