NCT01303588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_2 low-back-pain

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

February 24, 2011

Last Update Submit

January 18, 2013

Conditions

Low Back Pain

Keywords

elderly patients

Outcome Measures

Primary Outcomes (1)

  • Functional rating Index (FRI)

    3 months

Secondary Outcomes (9)

  • Functional Rating Index

    6 months

  • Visual Analogue Scale

    3, 6 months

  • FFb-HR

    3, 6 months

  • Pain medication

    6 months

  • Falls

    6 months

  • +4 more secondary outcomes

Study Arms (3)

Waiting Group

NO INTERVENTION

Qigong

ACTIVE COMPARATOR
Behavioral: Qigong

Yoga

ACTIVE COMPARATOR
Behavioral: Yoga

Interventions

YogaBEHAVIORAL

24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months

Yoga
QigongBEHAVIORAL

12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months

Qigong

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité University Berlin, Institute for Social Medicine, Epidemiology, Health Economics

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

YogaQigong

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesBreathing Exercises

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

May 1, 2011

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

DE(1)