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

NCT ID: NCT06457581

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-09-30

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.

Conditions

Pain; Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Dry Needling

Group Type: OTHER

Dry Needling

Intervention Type: OTHER

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.

serotonin reuptake inhibitor (SSRI)

Intervention Type: DRUG

serotonin reuptake inhibitor (SSRI)

Trigger points injections

Group Type: EXPERIMENTAL

Trigger points injections

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

serotonin reuptake inhibitor (SSRI)

serotonin reuptake inhibitor (SSRI)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chaudary Muhammad Akram Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall22/724

Identifier Type: -

Identifier Source: org_study_id