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

Not Applicable

Active, not recruiting

• Conditions: Fibromyalgia; Pain
• Interventions: Other: Dry Needling; Procedure: Trigger points injections; Drug: serotonin reuptake inhibitor (SSRI)

• Registration Number: NCT06457581
• Lead Sponsor: Superior University

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.

Detailed 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.

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Needling	serotonin reuptake inhibitor (SSRI)	-
Dry Needling	Dry Needling	-
Trigger points injections	Trigger points injections	-

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	12 Months	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.
Fibromyalgia Impact Questionnaire:	12 months	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

Trial Locations

Locations (1)

Chaudary Muhammad Akram Teaching Hospital; 🇵🇰 Lahore, Punjab, Pakistan