- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01725295
Neurostructural Integration Technique for Fibromyalgia (NST)
November 9, 2012 updated by: Professor Geraldine McCarthy, University College Dublin
Fibromyalgia is a common cause of widespread musculoskeletal pain.
The investigators have found that our patients seem to benefit from a soft tissue physical therapy called neurostructural integration therapy (NST).
The purpose of this study was to compare NST to hydrotherapy which is already used to manage fibromyalgia symptoms.
Study Overview
Detailed Description
Twenty female patients who met the American College of Rheumatology diagnostic criteria for the classification of FM were enrolled in the study.
Patients were randomly allocated to receive either hydrotherapy or NST.
Patient evaluations were performed at baseline, six weeks, three months, and six months.
Primary outcome measures included the SF-36 quality of life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score.
Duration of morning stiffness and duration of weekly aerobic exercise as reported by the participants were secondary outcome measures.
Statistics analysis was performed by standard parametric and non parametric methods.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Dublin, Ireland, 7
- Mater Misericordiae Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Any patient who fulfills ACR diagnostic criteria for fibromyalgia
Exclusion Criteria:
- Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: NST
A form of physical therapy to relieve symptoms of fibromyalgia
|
A form of physical therapy
|
|
ACTIVE_COMPARATOR: Hydrotherapy
An alternate form of physical therapy to relieve symptoms of fibromyalgia
|
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (ACTUAL)
April 1, 2004
Study Completion (ACTUAL)
April 1, 2004
Study Registration Dates
First Submitted
November 8, 2012
First Submitted That Met QC Criteria
November 9, 2012
First Posted (ESTIMATE)
November 12, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
November 12, 2012
Last Update Submitted That Met QC Criteria
November 9, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NST (Other Grant/Funding Number: The Neurological Society of Thailand)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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