Effect of Suboccipital Release in Patients With Fibromyalgia Syndrome

NCT06879743 | Recruiting

• 1 other identifier: Effect of suboccipital release
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Cortisol level

  Changes in pain from baseline to six weeks after begining of intervention

  Six weeks after begining of intervention

Secondary Outcomes (1)

• Fibromyalgia impact questionair

  Six weeks after begining of intervention

Study Arms (2)

Selected physiotherapy programme

OTHER

Other: Suboccipital release

Suboccipital release

ACTIVE COMPARATOR

Other: Suboccipital release

Interventions

Suboccipital release OTHER

The ptients in this group recieve suboccipital release. The patient is positioned in a supine (lying on their back) position, allowing full relaxation of the cervical spine. The therapist places their fingertips or hands under the patient's occiput, making contact with the suboccipital muscles. Using gentle, sustained pressure, the therapist allows the weight of the head to create a release, often holding for 1-5 minutes. Subtle adjustments may be made, such as slight traction or rocking, to facilitate myofascial release and relaxation.

Selected physiotherapy programme; Suboccipital release

Eligibility Criteria

• Age: 20 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy laps at cairo university

Cairo, 12612, Egypt

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Rowida Abdelgleel, Lecturer

CONTACT

01152322678; rowidaabdelglel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: February 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 10, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

EG (1)