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Trial record 85 of 424 for:    Pregabalin

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
Sponsor:
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: Ba-Duan-Jin Drug: Pregabalin capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin

Arm Intervention/treatment
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.

Other: Ba-Duan-Jin
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Qiuwei Peng, MD +8601088001132 ext +8601088001132 1185980093@qq.com
Contact: Juan Jiao, MD PhD +8601088001132 ext +8601088001132 jiao.juan@hotmail.com

Locations
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China, Beijing
Jiao Juan Recruiting
Beijing, Beijing, China, 100053
Contact: Juan J Jiao    +8601088001132 ext +8601088001132    jiao.juan@hotmail.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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Responsible Party: Juan Jiao, Deputy chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03797560     History of Changes
Other Study ID Numbers: Z181100001718153
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain

Additional relevant MeSH terms:
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Pregabalin
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs