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Clinical trial

Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors Versus Trigger Point Injection for Pain Management in Fibromyalgia

ID
Name
MSRSW/Batch-Fall22/724
Description
The principal objective is to contribute valuable insights that hold direct implications for medical practice and patient care, with the potential to influence health policy pertaining to fibromyalgia management.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-05-01
Trial end
2024-09-30
Status
Active (not recruiting)
Treatment
Dry Needling
Group A will undergo dry needling sessions twice a week over eight weeks, specifically targeting trigger points and tender points. Simultaneously, a consistent dosage of selective serotonin reuptake inhibitor (SSRI) will be administered and maintained throughout the entire duration of the study.
Arms:
Dry Needling
Trigger points injections
Group B will undergo a comprehensive intervention involving trigger point injections administered biweekly over eight weeks. These injections will specifically target trigger points. Additionally, a control measure will be implemented through simulated needling at non-specific points.
Arms:
Trigger points injections
serotonin reuptake inhibitor (SSRI)
serotonin reuptake inhibitor (SSRI)
Arms:
Dry Needling
Size
35
Primary endpoint
Pittsburgh Sleep Quality Index (PSQI)
12 Months
Fibromyalgia Impact Questionnaire:
12 months
Eligibility criteria
Inclusion Criteria: * Stable on SSRIs for at least three months (for Group A) * Age between 18 and 65 years * Participants suffering from recent cervical pain without any pathology Exclusion Criteria: * Presence of any other chronic pain conditions. * Contraindications to SSRIs or trigger point injections. * Pregnancy or lactation. * History of psychiatric disorders other than depression and anxiety
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2024-06-13

1 organization

1 product

2 indications

Organization
Superior University
Product
Serotonin Reuptake Inhibitor
Indication
Pain
Indication
Fibromyalgia