FibromyalgiaNCT06469996
Effects of Connective Tissue Massage in Patients With Fibromyalgia
A study testing Connective tissue massage and Self myofascial relaxation in people with Fibromyalgia, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Connective tissue massage and Self myofascial relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2024to 30 Aug 2024
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being a woman
- Being diagnosed with FMS,
- Being between the ages of 18-65 and volunteering.
Who cannot join
- Neurological, infectious, endocrine and other inflammatory rheumatic diseases, severe psychological disorders, any condition that prevents exercise (advanced cardiac respiratory or orthopedic problems),
- Malignancy
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Songul
Elâzığ, 23100
Songul Baglan Yentur, 04242370000, songulbaglan23@hotmail.com
Songul Baglan Yentur, songulbaglan23@hotmail.com
About this study
Official title: Effects of Connective Tissue Massage and Self Myofascial Release in Patients With Fibromyalgia
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group.
Read the detailed description
Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. It is often associated with symptoms such as decreased physical strength, fatigue, sleep disturbances, gastrointestinal disorders and psychiatric disorders such as depression. Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. In the last two decades, massage applications using tools of various densities, materials, shapes and sizes (such as Foam Roller (FR), roller massagers, sticks or balls) and actively self-administered by individuals have rapidly gained popularity. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group. Treatments will be applied for 6 weeks, 2 days a week for a total of 12 sessions.
- Conditions
- Fibromyalgia
- Being tested
- Connective tissue massage, Self myofascial relaxation
- Keywords
- Fibromyalgia, Connective tissue massage, Myofascial release, Foam roller
- 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 will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively.
Self myofascial relaxationOther
Self myofascial relaxation will be practiced with foam roller in patients with Fibromyalgia.
| Study group | Role | What they receive |
|---|---|---|
| Connective tissue massage group | Experimental | Connective tissue massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively. Receives: Other: Connective tissue massage |
| Self myofascial relaxation group | Experimental | Self myofascial relaxation will be applied using foam roller. The practice will continue two days a week for 6 weeks. Foam roller exercise is performed in the supine position with knees bent, hands locked behind the neck and foam roller is placed between the shoulder blades. Receives: Other: Self myofascial relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
disability
Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions to assess the health status and physical functionality of an individual diagnosed with FM.
Measured: 2 minutes
Secondary outcomes (2)
pain assesment
Pain will be evaluated with Visual Analog Scale. Patients will be asked to rate the severity of pain between 0-10.
Measured: 1 minute
Quality of life assesment
Quality of life will be assessed with the Health Assessment Questionnaire (HRA). The HRA is one of the first disability questionnaires used in adults with arthritis. The highest scores of each subgroup are summed and the result is divided by eight to obtain the participant's SDQ score.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start20 Jun 2024 (estimated)
- Primary completion20 Aug 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
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
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songül Bağlan Yentür, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469996
- Sponsor's protocol ID
- 2024/08-06
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Connective Tissue Massage and Self Myofascial Release in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06469996
- Acronym / sponsor ID
- 2024/08-06
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Connective tissue massage, Myofascial release, Foam roller
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 20 Jun 2024 (estimated)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 24 Jun 2024 (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.
Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group.
Detailed description
Fibromyalgia syndrome (FMS) is associated with chronic widespread pain and at least eleven positive tender points out of 18 according to the American College of Rheumatology (ACR) 1990 criteria. It is often associated with symptoms such as decreased physical strength, fatigue, sleep disturbances, gastrointestinal disorders and psychiatric disorders such as depression. Connective tissue massage (CTM), one of the various manual therapy techniques for FMS, produces local mechanical effects on mast cells in the connective tissue with short and long tractions, thereby reducing sympathetic activity and producing vasodilation. In the last two decades, massage applications using tools of various densities, materials, shapes and sizes (such as Foam Roller (FR), roller massagers, sticks or balls) and actively self-administered by individuals have rapidly gained popularity. The aim of the study was to compare the effectiveness of self myofascial release technique and connective tissue massage in patients with FMS. At least 30 FMS patients will be included in the study. Fibromyalgia Impact Questionnaire, pain, quality of life and sleep quality will be evaluated. CTM will be practiced to study group and foam roller will be practiced to control group. Treatments will be applied for 6 weeks, 2 days a week for a total of 12 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective tissue massage group | Experimental | Other: Connective tissue massageConnective tissue massage will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively. |
| Self myofascial relaxation group | Experimental | Other: Self myofascial relaxationSelf myofascial relaxation will be applied using foam roller. The practice will continue two days a week for 6 weeks. Foam roller exercise is performed in the supine position with knees bent, hands locked behind the neck and foam roller is placed between the shoulder blades. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being a woman
- Being diagnosed with FMS,
- Being between the ages of 18-65 and volunteering.
Key exclusion criteria (3 listed)
- Neurological, infectious, endocrine and other inflammatory rheumatic diseases, severe psychological disorders, any condition that prevents exercise (advanced cardiac respiratory or orthopedic problems),
- Malignancy
- Being pregnant
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 will be applied by an experienced physiotherapist for a total of 12 sessions 2 days a week for 6 weeks. While the patients are in sitting position, starting from the lumbosacral region, the lower thoracic, scapular, interscapular and cervical regions will be included in the treatment respectively. | Other | Connective tissue massage group |
| Self myofascial relaxationSelf myofascial relaxation will be practiced with foam roller in patients with Fibromyalgia. | Other | Self myofascial relaxation group |
Primary outcome
disability
Time frame: 2 minutes
Fibromyalgia Impact Questionnaire is a scale consisting of 10 questions to assess the health status and physical functionality of an individual diagnosed with FM.
2 secondary outcomes
pain assesment
Time frame: 1 minute
Quality of life assesment
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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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.
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 Self myofascial relaxation in people with Fibromyalgia, run by Firat 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability (time frame: 2 minutes). 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 24 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.