Qigong and Exercise for Neck Pain in Adults (QENA) | NCT00615732

Studies
Qigong and Exercise for Neck Pain in Adults (QENA)

NCT00615732

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jul 10, 2012Estimated

Enrollment

123Actual

Phase

Not Applicable

Conditions

Chronic Neck Pain

Interventions

Qigong
exercise therapy

Countries

Germany

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 2012

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

Mar 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Feb 1, 2008

First Submission Date that Met QC Criteria

Feb 1, 2008

First Posted Date

Feb 14, 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

Jul 9, 2012

Last Update Posted Date

Jul 10, 2012Estimated

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

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	qigong	Procedure: Qigong
2	Active Comparator	exercise therapy	Procedure: exercise therapy
3	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Qigong	Procedure	18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
average pain intensity during the last 7 days measured on a visual analogue scale (VAS)		baseline, 3, 6, 12, and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Neck Pain and Disability Scale (NPAD, Wheeler 1999)		baseline, 3, 6, 12, and 24 months
health related quality of life (SF-36)		baseline, 3, 6, 12 and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years
neck pain more prominent than other pain in the spine
average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
normal mobility of the cervical spine
intellectual and physical ability to participate in the study
informed consent

Exclusion Criteria:

cervical pain related to malignancy
cervical pain due to an accident
inflammatory joint disorders
previous spine surgery
protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
use of pain drugs for other diseases (> 1x/week)
pregnancy
severe chronic or acute disease interfering with therapy attendance
alcohol or substance abuse
participation in another clinical trial in the last 6 months before study entry

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
Claudia M Witt, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center		Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21178832	Result	Rendant D, Pach D, Ludtke R, Reisshauer A, Mietzner A, Willich SN, Witt CM. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2011 Mar 15;36(6):419-27. doi: 10.1097/BRS.0b013e3181d51fca.

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D064906	Qigong
D005081	Exercise Therapy

ID	Term
D001945	Breathing Exercises
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics