NCT01725295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2012

Completed
Last Updated

November 12, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

November 8, 2012

Last Update Submit

November 9, 2012

Conditions

Fibromyalgia

Keywords

fibromyalgia treatmentphysical therapyhydrotherapy

Study Arms (2)

NST

EXPERIMENTAL

A form of physical therapy to relieve symptoms of fibromyalgia

Other: NST

Hydrotherapy

ACTIVE COMPARATOR

An alternate form of physical therapy to relieve symptoms of fibromyalgia

Other: Hydrotherapy

Interventions

NSTOTHER

A form of physical therapy

NST
HydrotherapyOTHER
Also known as: A form of physical therapy
Hydrotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient who fulfills ACR diagnostic criteria for fibromyalgia

You may not qualify if:

  • Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mater Misericordiae Hospital

Dublin, Dublin, 7, Ireland

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Rheumatologist

Study Record Dates

First Submitted

November 8, 2012

First Posted

November 12, 2012

Study Start

April 1, 2003

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

November 12, 2012

Record last verified: 2012-11

Locations

IE(1)