FibromyalgiaNCT05063188
Connective Tissue Massage With Fibromyalgia
A study testing Connective Tissue Massage and clinical pilates exercises in people with Fibromyalgia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to examine the effectiveness of clinical pilates exercises and connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean age=55.64±7.87). Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Connective Tissue Massage and clinical pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2019to 15 Oct 2020
- 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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:(a) having FM diagnosis according to American College of Rheumatology 2016 criteria, (b) being a women, (c) aged 20-65. (d) being stable in drug use for at least 6 months or more. (e) being volunteer to participate in this study.
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Exclusion Criteria:(a) have been exercising regularly for the past three months, (b) the presence of uncontrolled cardiopulmonary disease, (c) the presence of orthopedic, neurological or mental problems that may prevent exercise, (d) having undergone any surgery in the last six months for both groups, (e) pregnancy, (f) presence of malignancy, (g) not being able to participate in at least 75% of the training.
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Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Pamukkale, Denizli, 20070
About this study
Official title: Is Connective Tissue Massage Effective In Individuals With Fibromyalgia?
The aim of the study was to examine the effectiveness of clinical pilates exercises and connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean age=55.64±7.87). While connective tissue massage and clinical pilates exercises were applied to the intervention group, control group were applied only clinical pilates exercises.According to our results, connective tissue massage increased the effectiveness of clinical pilates exercises in individuals with FM.
- Conditions
- Fibromyalgia
- Being tested
- Connective Tissue Massage, clinical pilates exercises
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connective Tissue MassageOther
Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.
clinical pilates exercisesOther
Exercises were applied 3 times for 6 weeks, a total of 18 sessions. One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Not described Receives: Other: clinical pilates exercises |
| Intervention group | Experimental | Not described Receives: Other: Connective Tissue Massage; Other: clinical pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Location Inventory
Measured: 10 min
Fibromyalgia Impact Questionnaire
Measured: 15 min
Health Assessment Questionnaire
Measured: 10 min
Beck Anxiety Inventory
Measured: 10 min
Short Form-36
Measured: 10 min
Biopsychosocial Questionnaire
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start10 Sep 2019
- Primary completion20 Sep 2020
- Study completion15 Oct 2020
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Basakci Calik, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063188
- Sponsor's protocol ID
- Connective Tissue Massage
- Status last verified
- Sep 2021
- First submitted
- 22 Sep 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Connective Tissue Massage Effective In Individuals With Fibromyalgia?
- ClinicalTrials.gov ID
- NCT05063188
- Acronym / sponsor ID
- Connective Tissue Massage
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 30 Sep 2021 (actual)
- 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 the study was to examine the effectiveness of clinical pilates exercises and connective tissue massage in individuals with Fibromyalgia (FM). 32 women were randomly divided into two groups as intervention (n=15, mean age=48.80±7.48) and control (n=17, mean age=55.64±7.87). While connective tissue massage and clinical pilates exercises were applied to the intervention group, control group were applied only clinical pilates exercises.According to our results, connective tissue massage increased the effectiveness of clinical pilates exercises in individuals with FM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: clinical pilates exercises |
| Intervention group | Experimental | Other: Connective Tissue Massage, Other: clinical pilates exercises |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Connective Tissue MassageConnective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively. | Other | Intervention group |
| clinical pilates exercisesExercises were applied 3 times for 6 weeks, a total of 18 sessions. One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total). | Other | Control group, Intervention group |
Primary outcome
Pain Location Inventory
Time frame: 10 min
Fibromyalgia Impact Questionnaire
Time frame: 15 min
Health Assessment Questionnaire
Time frame: 10 min
Beck Anxiety Inventory
Time frame: 10 min
Short Form-36
Time frame: 10 min
Biopsychosocial Questionnaire
Time frame: 15 min
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 30 Sep 2021.
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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 Connective Tissue Massage and clinical pilates exercises 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?
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 30 Sep 2021. 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 Location Inventory (time frame: 10 min). The study lists 6 primary outcomes in all. 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 30 Sep 2021.