FibromyalgiaNSTNCT01725295
Neurostructural Integration Technique for Fibromyalgia
A study testing NST and Hydrotherapy in people with Fibromyalgia, run by University College Dublin at 1 site in Ireland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- NST and Hydrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2003to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient who fulfills ACR diagnostic criteria for fibromyalgia
Who cannot join
- Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- NST, Hydrotherapy
- Keywords
- fibromyalgia treatment, physical therapy, hydrotherapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSTOther
A form of physical therapy
HydrotherapyOther
Also called A form of physical therapy
| Study group | Role | What they receive |
|---|---|---|
| NST | Experimental | A form of physical therapy to relieve symptoms of fibromyalgia Receives: Other: NST |
| Hydrotherapy | Active comparator | An alternate form of physical therapy to relieve symptoms of fibromyalgia Receives: Other: Hydrotherapy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2012 (estimated)
- Study startApr 2003
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Geraldine McCarthy, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725295
- Sponsor's protocol ID
- NST
- Acronym
- NST
- Status last verified
- Nov 2012
- First submitted
- 8 Nov 2012
- Last updated
- 12 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostructural Integration Technique for Fibromyalgia
- ClinicalTrials.gov ID
- NCT01725295
- Acronym / sponsor ID
- NST / NST
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia treatment, physical therapy, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004 (actual)
- First posted
- 12 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NST | Experimental | Other: NSTA form of physical therapy to relieve symptoms of fibromyalgia |
| Hydrotherapy | Active comparator | Other: HydrotherapyAn alternate form of physical therapy to relieve symptoms of fibromyalgia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient who fulfills ACR diagnostic criteria for fibromyalgia
Key exclusion criteria (1 listed)
- Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSTA form of physical therapy | Other | NST |
| HydrotherapyAlso: A form of physical therapy | Other | Hydrotherapy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NST and Hydrotherapy in people with Fibromyalgia, run by University College Dublin at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2012.