Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT03797560|
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Ba-Duan-Jin Drug: Pregabalin capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia|
|Actual Study Start Date :||March 22, 2019|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Ba-Duan-Jin group
Ba-Duan-Jin therapy: The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital.
Placebo pregabalin capsules: Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.
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 Name: Baduanjin; Eight Brocades; Eight-Section Brocade
Active Comparator: Pregabalin group
Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise.
Active pregabalin capsules: As same usage as the placebo pregabalin capsules.
Drug: Pregabalin capsule
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03797560
|Contact: Qiuwei Peng, MD||+8601088001132 ext +email@example.com|
|Contact: Juan Jiao, MD PhD||+8601088001132 ext +firstname.lastname@example.org|
|Beijing, Beijing, China, 100053|
|Contact: Juan J Jiao +8601088001132 ext +8601088001132 email@example.com|