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NCT Number: NCT03797560

Comparison of Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia

Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiao Juan

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
  • be between the ages of 18 to 70 years.

Exclusion criteria

  • had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
  • be less than 40mm of pain VAS score;
  • had renal failure, and severe depression or anxiety;
  • had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
  • pregnancy or planned pregnancy within the study period;
  • patients residing more than 70 miles from the research site.

Treatment and study plan

Ba-Duan-Jin

Other

Ba-Duan-Jin is a common form of "self-health-care" Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases

Other names: Baduanjin; Eight Brocades; Eight-Section Brocade

Pregabalin capsule

Drug

Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.

Primary outcomes

  1. The change of the Visual Analogue Scale (VAS) for pain from baseline.

    Time frame: up to 1 week

    Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.

Secondary outcomes

  1. The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.

    Time frame: Baseline, week 4, week 8, and week 12.

    A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.

  2. The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.

    Time frame: Baseline, week 4, week 8, and week 12.

    The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.

  3. The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.

    Time frame: Baseline, week 4, week 8, and week 12.

    Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.

  4. The Beck II Depression Inventory (BDI)

    Time frame: Baseline, week 4, week 8, and week 12.

    The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.

  5. The change of the Perceived Stress Scale (PSS) from baseline.

    Time frame: Baseline, week 4, week 8, and week 12.

    The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.

  6. Global Impression of Change (PGIC) questionnaire evaluated at week 12.

    Time frame: Week 12.

    A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).

  7. The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.

    Time frame: Baseline, week 4, week 8, and week 12.

    The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients with Fibromyalgia

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 9, 2019
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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