Effectiveness of Dry Needling Adjuvant to Selective Serotonin Reputake Inhibitors vs TP Injection for Pain Management

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06457581
• Other study ID #: MSRSW/Batch-Fall22/724
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Pain

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