NCT03299192

Brief Summary

There is a major gap in knowledge about safe and effective treatment options for older adults with chronic low back pain. This project will determine the feasibility of conducting a full-scale trial evaluating Tai Chi, a promising "mind-body" intervention that seems particularly well-suited for older adults with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

May 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

April 2, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

May 31, 2017

Results QC Date

December 24, 2019

Last Update Submit

March 4, 2024

Conditions

Back Pain Lower Back Chronic

Outcome Measures

Primary Outcomes (1)

  • Change in Roland Morris Disability Questionnaire Score

    The score of the Roland-Morris Disability Questionnaire (RDMQ) is the total number of items checked, from a minimum of 0 to a maximum of 24, with a higher score indicating a higher experience of disability from back pain. The timeframe of the RMDQ is how a person feels within the last 7 days. Change was calculated as the value of the time point (3, 6, or 12 months) minus baseline

    Baseline, 3, 6, 12 months

Study Arms (3)

Tai Chi

EXPERIMENTAL

twice weekly classes for 12 weeks and then weekly for 6 weeks, every other week for 6 weeks and monthly for 3 months

Behavioral: Tai ChiOther: Usual Medical Care

Health Education

ACTIVE COMPARATOR

twice weekly classes for 12 weeks

Behavioral: Health EducationOther: Usual Medical Care

Usual Medical Care

ACTIVE COMPARATOR

the usual care to which participants are entitled by their health insurance

Other: Usual Medical Care

Interventions

Tai ChiBEHAVIORAL

Yang Style Tai Chi

Tai Chi
Health EducationBEHAVIORAL

Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain

Health Education
Usual Medical CareOTHER

Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.

Health EducationTai ChiUsual Medical Care

Eligibility Criteria

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

You may qualify if:

  • Be men or women at least 65 years of age
  • Have low back pain that has persisted for at least three months
  • Have had back pain on at least half the days in the last 6 months
  • Have at least moderate intensity low back pain
  • Have some activity limitations due to back pain
  • Be members of Kaiser Permanente Washington integrative health care system or have a regular source of health care and health insurance
  • Have normal cognition or only mild cognitive impairment
  • Be capable of understanding the study procedures and complying with them for the entire study period.
  • Live close enough to the class site for attendance to be practical
  • Give informed consent

You may not qualify if:

  • Have certain specific conditions of LBP
  • Prior lumbar spine surgery
  • Have sciatica, or scheduled visits to a neurosurgeon or orthopedic surgeon.
  • Receiving or seeking compensation for back pain
  • Red flags of serious underlying illness
  • Have practiced Tai Chi or yoga recently. Have other disabling conditions that might confound treatment effects
  • Conditions making consent or treatment difficult
  • Conditions making treatment unsafe or inappropriate
  • Unwillingness to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Interventions

Tai Ji

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Results Point of Contact

Title
Rene Hawkes, Project Manager
Organization
Kaiser Permanente
rene.j.hawkes@kp.org
206-287-2073

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research Specialists will be unaware of study group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of Tai Chi to Health Education and to Usual Medical Care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2017

First Posted

October 3, 2017

Study Start

May 1, 2016

Primary Completion

March 31, 2019

Study Completion

April 30, 2020

Last Updated

April 2, 2024

Results First Posted

April 2, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)