Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors vs TP Injection for Pain Management
1 other identifier
interventional
35
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Nov 2023
1 active site
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
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedJune 13, 2024
June 1, 2024
6 months
June 10, 2024
June 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
It includes 19 items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
12 Months
Fibromyalgia Impact Questionnaire:
It includes questions related to physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. Scores on the FIQ range from 0 to 100, with higher scores indicating greater impact and symptom severity
12 months
Study Arms (2)
Dry Needling
OTHERTrigger points injections
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chaudary Muhammad Akram Teaching Hospital
Lahore, Punjab Province, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 13, 2024
Study Start
November 1, 2023
Primary Completion
May 1, 2024
Study Completion
September 30, 2024
Last Updated
June 13, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share