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Neurostructural Integration Technique for Fibromyalgia (NST)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
NST
Hydrotherapy
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia treatment, physical therapy, hydrotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mater Misericordiae Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NST

Hydrotherapy

Arm Description

A form of physical therapy to relieve symptoms of fibromyalgia

An alternate form of physical therapy to relieve symptoms of fibromyalgia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 8, 2012
Last Updated
November 9, 2012
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT01725295
Brief Title
Neurostructural Integration Technique for Fibromyalgia
Acronym
NST
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia treatment, physical therapy, hydrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NST
Arm Type
Experimental
Arm Description
A form of physical therapy to relieve symptoms of fibromyalgia
Arm Title
Hydrotherapy
Arm Type
Active Comparator
Arm Description
An alternate form of physical therapy to relieve symptoms of fibromyalgia
Intervention Type
Other
Intervention Name(s)
NST
Intervention Description
A form of physical therapy
Intervention Type
Other
Intervention Name(s)
Hydrotherapy
Other Intervention Name(s)
A form of physical therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Mater Misericordiae Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland

12. IPD Sharing Statement

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Neurostructural Integration Technique for Fibromyalgia

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