NCT01333566

Brief Summary

The long-term goal of our research program is to develop an effective and cost-saving mind-body therapy to help patients with FM. The objective of this pilot study is to gather pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients using a specific type of qigong exercise, i.e. "six healing sound" qigong. Changes in relevant brain activity will be monitored in study subjects before and after the qigong exercise program, which may help us in better understanding the underlying mechanism of the qigong exercise. Data collected in this pilot study will help the investigators in preparation for a future clinical trial with a larger sample size. Our central hypothesis for the future clinical trial is that qigong exercise will lead to a significantly greater improvement in pain, fatigue, sleep quality, and quality of life in the experimental group compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

5.6 years

First QC Date

April 8, 2011

Last Update Submit

July 1, 2016

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • To investigate the effect of qigong exercise on pain

    up to 3months

Secondary Outcomes (3)

  • To investigate the effect of qigong exercise on fatigue

    up to 3 months

  • To investigate the effect of qigong exercise on sleep quality

    up to 3 months

  • To investigate the effect of qigong exercise the quality of life in FM patients.

    up to 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: Intervention Group

Control Group

PLACEBO COMPARATOR
Behavioral: Placebo Comparator: Control Group

Interventions

Intervention GroupBEHAVIORAL

The study will include one week baseline phase, 6-week intervention phase, and a 3-month follow-up evaluation. Subjects in the intervention group will go through three training sessions during the baseline phase, weekly group exercise sessions once per week and daily home exercises two times each day during the intervention phase, and a follow-up evaluation in three months after the intervention phase.

Intervention Group
Placebo Comparator: Control GroupBEHAVIORAL

Subjects in the control group will be monitored during the baseline and intervention phase without participating in the interventional exercise. At the end of intervention phase, the subjects will have the option to stop their participation or switch to the intervention group.

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of primary FM, based on the 1990 American College of Rheumatology criteria (Wolfe et al, 1990),
  • between the ages of 18 and 70 years;
  • willing to withdraw from CNS-active therapies commonly used to treat FM; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches;
  • with a raw score \> 4 on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt et al, 1991);
  • and a mean visual analog scale (VAS) pain score \> 40 on a scale from 0 to 100.

You may not qualify if:

  • severe psychiatric illness;
  • a current major depressive episode (as determined by a Beck Depression Inventory (Beck et al, 1961) score \>25);
  • significant suicide risk;
  • abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study;
  • active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that had been stable for 3 months before screening);
  • current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea;
  • prostate enlargement or other genitourinary disorder (male patients);
  • or pregnancy or breastfeeding (female patients).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Wen Liu, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2011

First Posted

April 12, 2011

Study Start

July 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

US(1)