The Effect of Acupuncture Treatment on the Perception of... | NCT00369902

Studies
The Effect of Acupuncture Treatment on the Perception of Pain and Coping With Pain

NCT00369902

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Jul 21, 2009Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

Pain

Interventions

acupuncture

Countries

Israel

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

Status Module

Record Verification Date

Jul 2009

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

May 2006

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Aug 29, 2006

First Submission Date that Met QC Criteria

Aug 29, 2006

First Posted Date

Aug 30, 2006Estimated

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

Jul 19, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Name	Class
Assaf-Harofeh Medical Center	OTHER_GOV

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

The Purpose of this study is to evaluate whether cognitive and emotional components take part in the positive acupuncture effect on pain.

Detailed Description

The effect of acupuncture on pain intensity has been already investigated and confirmed. Recent publication (Pariente J., et a., 2005) indicated that acupuncture may affect midbrain areas, that are associated with cognitive control of pain.

The Pain Self Regulation Model (Levental, 1980)distinguishes between emotional response pain representations and cognitive pain representations. According to this model, emotional and cognitive pain representations leads to a new (cognitive or emotional) evaluation of the pain, that affects its perception and the ability to cope with it (Levental at al., 2001).

This study will try to assess the hypothesis that acupuncture treatment is involved in this process.

The study is designed as pilot study, limited to 45 patients.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Name	Type	Description	Arm Group Labels	Other Names
acupuncture	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients suffering from pain,who are reffered for acupuncture treatment,and consented to participate in this study

Exclusion Criteria:

children under 18 years of age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

41 consequtive patients with chronic musculosckeletal pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dorit Gamus, M.D., Ph.D.	Sheba Hospital, Tel Hashomer, ISRAEL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Hospital,		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided