FibromyalgiaNCT04970511
Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome
A study testing BBAT (Basic Body Awareness Therapy) and Online BBAT training in people with Fibromyalgia, run by University of Beykent at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome. H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- BBAT (Basic Body Awareness Therapy) and Online BBAT training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 20 Dec 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-65
- Being diagnosed with FMS according to ACR 2016 criteria
- To be diagnosed with FMS at least 6 months before the study
- Reported pain intensity > 4 (Visual Analog Scale 0-10),
- Individuals that do not have barriers to basic body awareness therapy.
Who cannot join
- Pregnancy or intention to become pregnant within the study period.
- Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
- Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
- Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.
Read the detailed description
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.
Goals:
- Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome.
- Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome
- Conditions
- Fibromyalgia
- Being tested
- BBAT (Basic Body Awareness Therapy), Online BBAT training
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBAT (Basic Body Awareness Therapy)Behavioural
The group I: BBAT Face-to-Face Training (60 min) will be provided.
Online BBAT trainingBehavioural
The group II: Online BBAT training (60 min) will be provided.
| Study group | Role | What they receive |
|---|---|---|
| The group I: BBAT Face-to-Face Training group | Experimental | Exercises consist of supine, sitting, standing position awareness exercises and walking exercises.
Considering eight weeks, the training is designed to progress gradually each week. Receives: Behavioral: BBAT (Basic Body Awareness Therapy) |
| The group II: Online BBAT training group | Experimental | Patients in the Internet-based BBAT group will conduct their training with a physiotherapist to be connected via an online video conference system.
This group will be given the same training as the face-to-face BBAT group. Receives: Behavioral: Online BBAT training |
| The group III: Control group | No intervention | No training will be applied to the control group patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Fibromyalgia Impact Questionnaire (FIQR)
Limitations and functional disability in patients with fibromyalgia will be evaluated.
Measured: 8 weeks
Secondary outcomes (10)
Algometer
Pressure pain threshold measurement of characteristic 18 tender points of fibromyalgia syndrome will be performed.
Measured: 8 weeks
Posture Screen Mobile (PSM)
Posture will be evaluated with Posture Screen Mobile (PSM), an iPad application.
Measured: 8 weeks
The short-form McGill Pain Questionnaire
Pain will be evaluated with the short-form McGill Pain Questionnaire
Measured: 8 weeks
Trunk repositioning error
The trunk position sense indicated by trunk reposition errors will be evaluated with the inclinometer device.
Measured: 8 weeks
Awareness-Body-Chart=ABC
Awareness-Body-Chart=ABC will be used to assess body awareness.
Measured: 8 weeks
Postural stability
Postural stability will be evaluated with a portable force platform.
Measured: 8 weeks
Single Leg Balance
Balance will be evaluated with the single leg balance test with eyes open and closed.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index.
Measured: 8 weeks
SF-36 (the MOS 36-item short-form health survey)
As the general quality of life, the SF-36 (the MOS 36-item short-form health survey) form will be used.
Measured: 8 weeks
Plasma Fibrinogen and Haptoglobin Protein Levels
Two plasma proteins, fibrinogen and haptoglobin, will be evaluated as markers of inflammation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start1 Jul 2021
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Beykent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Tahran, University of Beykent
- Investigators
- Özge TAHRAN, MSc, Principal investigator, Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970511
- Sponsor's protocol ID
- BBAT
- Status last verified
- Dec 2024
- First submitted
- 28 Jun 2021
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Face-to-Face and Internet-Based Basic Body Awareness Therapy in Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT04970511
- Acronym / sponsor ID
- BBAT
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of BeykentUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 21 Jul 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 our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.
Detailed description
The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.
H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.
H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.
Goals:
- Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome.
- Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The group I: BBAT Face-to-Face Training group | Experimental | Behavioral: BBAT (Basic Body Awareness Therapy)Exercises consist of supine, sitting, standing position awareness exercises and walking exercises. Considering eight weeks, the training is designed to progress gradually each week. |
| The group II: Online BBAT training group | Experimental | Behavioral: Online BBAT trainingPatients in the Internet-based BBAT group will conduct their training with a physiotherapist to be connected via an online video conference system. This group will be given the same training as the face-to-face BBAT group. |
| The group III: Control group | No intervention | –No training will be applied to the control group patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be between the ages of 18-65
- Being diagnosed with FMS according to ACR 2016 criteria
- To be diagnosed with FMS at least 6 months before the study
- Reported pain intensity > 4 (Visual Analog Scale 0-10),
- Individuals that do not have barriers to basic body awareness therapy.
Key exclusion criteria (4 listed)
- Pregnancy or intention to become pregnant within the study period.
- Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
- Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
- Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -
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 |
|---|---|---|
| BBAT (Basic Body Awareness Therapy)The group I: BBAT Face-to-Face Training (60 min) will be provided. | Behavioural | The group I: BBAT Face-to-Face Training group |
| Online BBAT trainingThe group II: Online BBAT training (60 min) will be provided. | Behavioural | The group II: Online BBAT training group |
Primary outcome
The Revised Fibromyalgia Impact Questionnaire (FIQR)
Time frame: 8 weeks
Limitations and functional disability in patients with fibromyalgia will be evaluated.
10 secondary outcomes
Algometer
Time frame: 8 weeks
Posture Screen Mobile (PSM)
Time frame: 8 weeks
The short-form McGill Pain Questionnaire
Time frame: 8 weeks
Trunk repositioning error
Time frame: 8 weeks
Awareness-Body-Chart=ABC
Time frame: 8 weeks
Postural stability
Time frame: 8 weeks
Single Leg Balance
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
SF-36 (the MOS 36-item short-form health survey)
Time frame: 8 weeks
Plasma Fibrinogen and Haptoglobin Protein Levels
Time frame: 8 weeks
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 9 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Özge TAHRAN, MSc principal investigator
Beykent 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 BBAT (Basic Body Awareness Therapy) and Online BBAT training in people with Fibromyalgia, run by University of Beykent 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 4 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 9 Jan 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?
The Revised Fibromyalgia Impact Questionnaire (FIQR) (time frame: 8 weeks). 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 9 Jan 2025.