Yoga and Qigong for Elderly Patients With Chronic Low Bac... | NCT01303588

Studies
Yoga and Qigong for Elderly Patients With Chronic Low Back Pain

NCT01303588

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jan 21, 2013Estimated

Enrollment

176Actual

Phase

Phase 2Phase 3

Conditions

Low Back Pain

Interventions

Yoga
Qigong

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

Jan 2013

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 2011

Primary Completion Date

May 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 24, 2011

First Submission Date that Met QC Criteria

Feb 24, 2011

First Posted Date

Feb 25, 2011Estimated

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

Jan 18, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia M. Witt, Prof. Dr. med, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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 objective of this study is to evaluate whether yoga or qigong therapy is effective in treating low back pain in elderly patients compared to no therapy (waiting list control). The secondary aim is to compare yoga and qigong.

Detailed Description

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Waiting Group	No Intervention
Qigong	Active Comparator	Behavioral: Qigong
Yoga	Active Comparator	Behavioral: Yoga

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Yoga	Behavioral	24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months	Yoga

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional rating Index (FRI)		3 months

Secondary Outcomes

Measure	Description	Time Frame
Functional Rating Index		6 months
Visual Analogue Scale		3, 6 months
FFb-HR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women ≥ 65 years of age
Chronic low back pain since 6 months at least
Functional Rating Index (FRI) ≥ 2 last 7 days
Informed consent form signed

Exclusion Criteria:

Disc prolapse with acute neurological symptoms
Previous spinal operations
Severe organic or psychiatric disease conditions, not allowing to participate in the trial
Use of opioids
Drug- and alcohol-addiction
Participation in another clinical trial within the last 6 months
Participation in yoga or qigong training within the last 12 months
Planned physical therapy within study duration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015013	Yoga
D064906	Qigong

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026443	Spiritual Therapies

Browse Leaves

Not provided

Browse Branches

Not provided