FibromyalgiaNCT00302887
Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
An observational study of Fibromyalgia, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with… Read more about this study
- Who is it for?
- Ages 19 to 68 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- combined ultrasound therapy and connective tissue manipulation
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2003to Dec 2004
- Phase
- Observational
- 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 19 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The sample was derived from a population of 83 FM outpatients of the Hacettepe University School of Physical Therapy and Rehabilitation
Who may be able to join
- Women with pain depending to FM, with an intensity interfering to activities of daily living for a duration of at least six months, able to participate of 20 physiotherapy sessions within a four week period, volunteer for participating to the study without taking any drugs acting on the nervous system such as antidepressants, myorelaxants, analgesics or hypnotics, in the study period.
Who cannot join
- evidence of neurological, infectious, endocrine and other inflammatory rheumatic diseases, and experience with any kind of manual and/or electrotherapy, within six months before the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, School of Physical Therapy and Rehabilitation
Ankara, 06100
About this study
Official title: Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
The aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with fibromyalgia.
Read the detailed description
This is an observational prospective cohort study, investigating short and long term results of physiotherapy applications in 20 female patients with fibromyalgia. Physical characteristics of the subjects were recorded. Intensity of pain, complaint of non-restorative sleep, and impact of fibromyalgia on functional activities were evaluated by visual analogue scales. All evaluations were performed before and after 20 sessions of treatment, which included connective tissue manipulation of the back daily, for a total of 20 sessions and combined ultrasound therapy of the upper back region every other session. One year follow-up evaluations could be performed on 14 subjects.
- Conditions
- Fibromyalgia
- Being tested
- combined ultrasound therapy, connective tissue manipulation
- Keywords
- fibromyalgia, connective tissue manipulation, ultrasound therapy, high voltage pulsed galvanic stimulation
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined ultrasound therapyDevice
connective tissue manipulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
The intensity of pain was evaluated by 0-10 cm visual analogue scales (VASs). On the VAS, "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".
Measured: All evaluations were performed before and after 20 sessions of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startAug 2003
- Primary completionDec 2004
- Study completionDec 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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkim Çıtak Karakaya, Hacettepe University
- Investigators
- İlkim Çıtak Karakaya, PT. PhD., Principal investigator, PT. PhD. Assist. Prof.Türkan Akbayrak, PT. PhD., Study director, PT. PhD. Assoc. Prof.Funda Demirtürk, PT. PhD., Study chair, Research assistantGamze Ekici, PT. MSc., Study chair, Research assistantYeşim Bakar, PT. PhD., Study chair, Assist. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302887
- Sponsor's protocol ID
- HEK06/12-39
- Status last verified
- Mar 2006
- First submitted
- 14 Mar 2006
- Last updated
- 14 Mar 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Results of Connective Tissue Manipulation and Combined Ultrasound Therapy in Patients with Fibromyalgia
- ClinicalTrials.gov ID
- NCT00302887
- Acronym / sponsor ID
- HEK06/12-39
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, connective tissue manipulation, ultrasound therapy, high voltage pulsed galvanic stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Aug 2003 (actual)
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 15 Mar 2006 (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.
The aim of this study was to evaluate the short term and one year follow-up results of connective tissue manipulation and combined ultrasound therapy (ultrasound and high voltage pulsed galvanic stimulation) in terms of pain, complaint of non-restorative sleep and impact on the functional activities in patients with fibromyalgia.
Detailed description
This is an observational prospective cohort study, investigating short and long term results of physiotherapy applications in 20 female patients with fibromyalgia. Physical characteristics of the subjects were recorded. Intensity of pain, complaint of non-restorative sleep, and impact of fibromyalgia on functional activities were evaluated by visual analogue scales. All evaluations were performed before and after 20 sessions of treatment, which included connective tissue manipulation of the back daily, for a total of 20 sessions and combined ultrasound therapy of the upper back region every other session. One year follow-up evaluations could be performed on 14 subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample was derived from a population of 83 FM outpatients of the Hacettepe University School of Physical Therapy and Rehabilitation
Key inclusion criteria (1 listed)
- Women with pain depending to FM, with an intensity interfering to activities of daily living for a duration of at least six months, able to participate of 20 physiotherapy sessions within a four week period, volunteer for participating to the study without taking any drugs acting on the nervous system such as antidepressants, myorelaxants, analgesics or hypnotics, in the study period.
Key exclusion criteria (1 listed)
- evidence of neurological, infectious, endocrine and other inflammatory rheumatic diseases, and experience with any kind of manual and/or electrotherapy, within six months before the study.
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 |
|---|---|---|
| combined ultrasound therapy | Device | – |
| connective tissue manipulation | Procedure or surgery | – |
Primary outcome
pain intensity
Time frame: All evaluations were performed before and after 20 sessions of treatment.
The intensity of pain was evaluated by 0-10 cm visual analogue scales (VASs). On the VAS, "0" indicated "no pain" and the "10" indicated "the worst imaginable pain".
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 14 Mar 2025.
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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.
İlkim Çıtak Karakaya, PT. PhD. principal investigator
PT. PhD. Assist. Prof.
Türkan Akbayrak, PT. PhD. study director
PT. PhD. Assoc. Prof.
Funda Demirtürk, PT. PhD. study chair
Research assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 14 Mar 2025. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
pain intensity (time frame: All evaluations were performed before and after 20 sessions of treatment.). It is what the study was designed to measure, not a finding.
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 14 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.