The Treatment of the Median Nerve for the Elimination of... | NCT00634738

Studies
The Treatment of the Median Nerve for the Elimination of the Symptoms Associated With the Carpal Tunnel Syndrome

NCT00634738

Sponsor

Guy Hains Chiropractor

Status

Completed

Last Update Posted

Jun 28, 2011Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Compression Neuropathy, Carpal Tunnel

Interventions

Ischemic Compression (thumb Pressure)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
no grants

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 6, 2008

First Submission Date that Met QC Criteria

Mar 12, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In carpal tunnel syndrome,trigger points are often found in the biceps muscle,in the aponeurosis of the biceps and in the pronator teres muscle.

We hypothesise that by eliminating these trigger points,using ischemic compressions, may diminish the symptoms.

Detailed Description

Using one thumb on the other,the pressure is applied 10 seconds on each TrPs.The treatment is done on each visit for a total of 15(without Charge).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
one	Experimental		Procedure: Ischemic Compression (thumb Pressure)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ischemic Compression (thumb Pressure)	Procedure	Pressure, one thumb on the other, applied on the trigger points	one

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levine DW Questionnaire (J.Bone Joint Surg Am 1993;75:1585-92)on carpal tunnel syndrome		after 15treatments,30 days after,6 months later

Secondary Outcomes

Measure	Description	Time Frame
A numerical scale,filled by the patient,where they give their perceived improvement from 0% to 100%.		After 15 treatments, 30 days later and 6 months later.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between 20 and 60 years old,
Numbness in the hand affecting the thumb, the index finger, the middle finger and half the ring finger,
To have suffered from discomfort on a daily basis for at least three months and to agree to a course of 15 chiropractic treatments at no cost.

Exclusion Criteria:

History of upper limb or neck surgery,
Pregnancy and systemic pathologies possibly related to CTS, such as hypothyroidism, diabetes and rheumatoid arthritis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Descarreaux, DC PHD	UQTR	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guy Hains 2930 Côte RIchelieu		Trois-Rivières	Quebec	G8Z3Y8	Canada

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019050	Acupressure

Ancestor Terms

ID	Term
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided