NCT02401386

Brief Summary

In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep quality and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

March 24, 2015

Last Update Submit

January 18, 2018

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity

Outcome Measures

Primary Outcomes (2)

  • The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.

    baseline, 4 weeks, 8 weeks, 12 weeks

  • The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (5)

  • The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

  • The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

  • The change of Beck depression inventory (BDI) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

  • The change of Perceived Stress Scale (PSS) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

  • The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks

    baseline, 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

EB group

EXPERIMENTAL

Trained and guided by EB certified physicians, patients in EB group received closely supervised, group-format EB program and practiced EB for one hour, twice weekly for 12 weeks in the Guang'anmen Hospital.

Behavioral: The Eight Brocades

Control group

NO INTERVENTION

The participants in usual therapy-controlled group will stay on their previous treatment through 12 weeks. As compensation, they will be invited to receive LEB training for 12 weeks after the end of the study.

Interventions

The Eight BrocadesBEHAVIORAL

Patients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB. Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc. The program will be taught by experienced EB masters.

EB group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM.
  • On a stable variety and dosage of pharmacologic for FM ≥4 weeks

You may not qualify if:

  • Prior experience with EB or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong, Tai Chi and yoga since these share some of the principles of EB.
  • Dementia, cancer, or other serious medical conditions limiting ability to participate in the Eight Brocades or strength training, as determined by the study physicians.
  • Any other diagnosed medical condition known to contribute to FM symptomatology that is not under adequate control for the study period such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
  • Positive urine pregnancy test at baseline or planning pregnancy within the study period.
  • Reside \>70 miles from the research site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Juan Jiao, M.D.,PhD

    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

March 24, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Locations

CN(1)