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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06457581
Other study ID # MSRSW/Batch-Fall22/724
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date September 30, 2024

Study information

Verified date June 2024
Source Superior University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The study aims to outline distinct patient subgroups manifesting heightened responsiveness to one therapeutic intervention vis-à-vis the other, thereby facilitating the formulation of more personalized and efficacious treatment modalities.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 35
Est. completion date September 30, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Procedure:
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.
Drug:
serotonin reuptake inhibitor (SSRI)
serotonin reuptake inhibitor (SSRI)

Locations

Country Name City State
Pakistan Chaudary Muhammad Akram Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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