Effect of Suboccipital Release in Patients With Fibromyalgia Syndrome

Effect of Suboccipital Release on Neck Pain and Quality of Life in Patients With Fibromyalgia Syndrome

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

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Suboccipital release

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rowida Abdelgleel, Lecturer; Phone Number: 01152322678; Email: rowidaabdelglel@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12612
    • Recruiting
    • Faculty of physical therapy laps at cairo university
    • Contact: Huda Zakaria, Professor; Phone Number: +201013107750; Email: hodamzakaria2009@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Selected physiotherapy programme	Other: Suboccipital release; 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.
Active Comparator: Suboccipital release	Other: Suboccipital release; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol level	Changes in pain from baseline to six weeks after begining of intervention	Six weeks after begining of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia impact questionair	Changes of quality of life from baseline to six weeks after begining of interventio	Six weeks after begining of intervention

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 10, 2025

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Effect of suboccipital release

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No