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NCT Number: NCT06879743

Effect of Suboccipital Release 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

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy laps at cairo university

Cairo, 12612, Egypt

Location status: Recruiting

Location contact

Huda Zakaria, Professor

CONTACT

[email protected]

+201013107750

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cortisol level

    Time frame: Six weeks after begining of intervention

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

Secondary outcomes

  1. Fibromyalgia impact questionair

    Time frame: Six weeks after begining of intervention

    Changes of quality of life from baseline to six weeks after begining of interventio

Study contacts

Contact information is provided by the study sponsor or research team.

Rowida Abdelgleel, Lecturer

CONTACT

[email protected]

01152322678

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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