Effect of Suboccipital Release in Patients With Fibromyalgia Syndrome

Not Applicable

Recruiting

• Conditions: Fibromyalgia

• Registration Number: NCT06879743
• Lead Sponsor: Cairo University

Brief Summary

This study was designed to examine the efficacy of suboccipital release in Patients With FMS and to provide preliminary evidence regarding its effects on pain and QOL by objectively measuring Cortisol level in FMS patien

Detailed Description

Forty female patients with FM ( age : 20- 45 Years ) participated in the study after suing the consent form . Participants were randomly allocated assigned into 2 equal groups ( control group \[ G1 \] and study \[G2 \] ) . Group

1 received selected physical therapy programme. Group 2 recieved suboccipital release. All participants were assessed for cortisol and pain level by using visual analogues scale and neck disability scale. Also participants were assessed by pressure algometer for pain intensity. Participants were assessed for QOL by FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQR) . treatment was done 3 sessions per weeks for successive 6 weeks pre and post assessment for all valuable were Done

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• women between 20-45 years old, (ii) diagnoses according to the 2016

American College of Rheumatology criteria for fibromyalgia [1]

• Symptoms have been present at a similar level for at least three months (iii) Absence of other disorders that causes similar symptoms: systemic lupus erethromatosis (SLE), rheumatoid arthritis (RA) and Lyme disease based on laboratory investigations (erythrocyte sedimentation rate (ESR), Anti anti-cyclic citrullinated peptide (Anti CCP), antinuclear antibody (ANA) and Rheumatoid factor(RF)).

Exclusion Criteria

• any medical, neurological, or psychiatric illness, use of strong opioids or other painkillers except paracetamol and/or ibuprofen, benzodiazepine, illicit drug or alcohol use, recent use of cannabis, pregnancy, breast feeding, and the presence of pain syndromes other than FM. Presence of other autoimmune disorders e.g.: rheumatoid arthritis and systemic lupus erethromatosus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cortisol level	Six weeks after begining of intervention	Changes in pain from baseline to six weeks after begining of intervention

Secondary Outcome Measures

Name	Time	Method
Fibromyalgia impact questionair	Six weeks after begining of intervention	Changes of quality of life from baseline to six weeks after begining of interventio

Trial Locations

Locations (1)

Faculty of physical therapy laps at cairo university; 🇪🇬 Cairo, Egypt