FibromyalgiaFMNCT00636623
Comparison of Exercise and Massage in Fibromyalgia
A study testing Pilates exercises and Connective tissue massage in people with Fibromyalgia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The present study was designed to analyse and compare the effects of Pilates exercises and connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance, anxiety, progress, and health related quality of life in females with fibromyalgia (FM) Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pilates exercises and Connective tissue massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2006to Aug 2007
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- being female
- being over 25 years old
- meeting the criteria for FM as defined by the American College of Rheumatology
- having pain in the neck and shoulder region
- never having been treated for FM.
Who cannot join
- infection
- fever or an increased tendency to bleed
- severe physical impairment
- inflammatory diseases
- cardiopulmonary disorders
- uncontrolled endocrine disorders
Show all 12Show fewer
- allergic disorders
- pregnancy
- malignancy
- severe psychiatric illnesses
- factors known to affect autonomic function
- medication usage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia
The present study was designed to analyse and compare the effects of Pilates exercises and connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance, anxiety, progress, and health related quality of life in females with fibromyalgia (FM)
Read the detailed description
Treatment of FM is difficult. Conventional treatments do not appear to be managing the problem effectively and this has led to other forms of treatment. The aim of treating FM is to decrease pain and increase function by means of a multimodal therapeutic strategy, which, in most cases, includes pharmacological and non-pharmacological interventions. In the literature on non-pharmacological treatment approaches for FM, different managements are described, such as exercise, electrotherapy, patient education, self-management programmes, massage techniques, cryotherapy, and acupuncture. There are a number of reasons why patients choose these complementary and alternative medicine approaches, including dissatisfaction with conventional treatments or concerns over the toxicity of drugs. However, there is no consensus about which treatment approach is the best.The current randomised controlled trial was undertaken as a first pilot study to assess and compare the effectiveness of Pilates exercises, an active-group therapy, and connective tissue massage, a passive-personalised therapy, in the management of FM in females.
- Conditions
- Fibromyalgia
- Being tested
- Pilates exercises, Connective tissue massage
- Keywords
- Pilates Exercises, Connective Tissue Massage
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Also called No drug name
15 FM patients participated in the PE programme three times a week during a 4-week period
Connective tissue massageOther
21 patients received CTM, three times a week during a 4-week period
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Pilates exercises Receives: Other: Pilates exercises |
| 1 | Other | Connective tissue massage Receives: Other: Connective tissue massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale, algometry, State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of the treatments.
Measured: For All measurements aproximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionAug 2007
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 Pamukkale 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Investigators
- Gamze Ekici, PhD, Principal investigator, Pamukkale UniversityTurkan Akbayrak, Assoc. Prof., Study director, Hacettepe UniversityEdibe Yakut, Prof, Study director, Hacettepe UniversityNaciye Vardar, MsC, Study director, Hacettepe UniversityYavuz Yakut, Prof, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636623
- Sponsor's protocol ID
- Ekici - 2
- Other IDs
- ISRCTN12345678
- Acronym
- FM
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pilates Exercises and Connective Tissue Massage in Females With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00636623
- Acronym / sponsor ID
- FM / Ekici - 2
- Conditions
- Fibromyalgia
- Keywords
- Pilates Exercises, Connective Tissue Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 14 Mar 2008 (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 present study was designed to analyse and compare the effects of Pilates exercises and connective tissue massage in terms of pain intensity, pain pressure threshold and tolerance, anxiety, progress, and health related quality of life in females with fibromyalgia (FM)
Detailed description
Treatment of FM is difficult. Conventional treatments do not appear to be managing the problem effectively and this has led to other forms of treatment. The aim of treating FM is to decrease pain and increase function by means of a multimodal therapeutic strategy, which, in most cases, includes pharmacological and non-pharmacological interventions. In the literature on non-pharmacological treatment approaches for FM, different managements are described, such as exercise, electrotherapy, patient education, self-management programmes, massage techniques, cryotherapy, and acupuncture. There are a number of reasons why patients choose these complementary and alternative medicine approaches, including dissatisfaction with conventional treatments or concerns over the toxicity of drugs. However, there is no consensus about which treatment approach is the best.The current randomised controlled trial was undertaken as a first pilot study to assess and compare the effectiveness of Pilates exercises, an active-group therapy, and connective tissue massage, a passive-personalised therapy, in the management of FM in females.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Other: Pilates exercisesPilates exercises |
| 1 | Other | Other: Connective tissue massageConnective tissue massage |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- being female
- being over 25 years old
- meeting the criteria for FM as defined by the American College of Rheumatology
- having pain in the neck and shoulder region
- never having been treated for FM.
Key exclusion criteria (12 listed)
- infection
- fever or an increased tendency to bleed
- severe physical impairment
- inflammatory diseases
- cardiopulmonary disorders
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 |
|---|---|---|
| Pilates exercisesAlso: No drug name15 FM patients participated in the PE programme three times a week during a 4-week period | Other | 2 |
| Connective tissue massage21 patients received CTM, three times a week during a 4-week period | Other | 1 |
Primary outcome
Visual Analogue Scale, algometry, State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of the treatments.
Time frame: For All measurements aproximately 1 hour
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 2008.
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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.
Gamze Ekici, PhD principal investigator
Pamukkale University
Turkan Akbayrak, Assoc. Prof. study director
Hacettepe University
Edibe Yakut, Prof study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Connective tissue massage in people with Fibromyalgia, run by Pamukkale 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 5 inclusion and 12 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 2008. 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?
Visual Analogue Scale, algometry, State-Trait Anxiety Inventory (STAI), Fibromyalgia Impact Questionnaire, and Nottingham Health Profile were used at baseline and at the end of the treatments. (time frame: For All measurements aproximately 1 hour). 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 2008.