FibromyalgiaNCT06194942
THE EFFECT OF CHIROPRACTIC THORACIC MANIPULATION ON PAIN, DEPRESSION, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH FIBROMYALGIA
A study testing chiropractic manipulation in people with Fibromyalgia, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effects of thoracic chiropractic manipulations on pain intensity, depression levels, sleep, and quality of life in women diagnosed with fibromyalgia. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- chiropractic manipulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 25 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having been diagnosed with fibromyalgia by a doctor.
- Having good cognitive status.
- Willingness to participate in the study voluntarily.
- Being a female aged between 25 and 45.
- The symptoms persisting without any degree of improvement or decrease recently.
- Having dysfunction (limited movement) in the thoracic region.
- Having no condition that would prevent high-velocity low-amplitude (HVLA) manipulation.
Who cannot join
- Receiving any non-pharmacological treatment.
- Having heart, kidney, or liver failure.
- Having inflammatory, psychiatric, neurological, and/or chronic progressive systemic diseases.
- Pregnancy.
- Having a history of acute or past fractures.
- Malignancy history.
Show all 12Show fewer
- Having a history of thoracic surgery.
- Having thoracic hernias, radiculopathy, motor deficits spondylosis, spondylolisthesis, narrow canal, extruded hernia, disc herniation, discitis diagnoses.
- Metabolic bone diseases.
- Infection, fever, hypotension, respiratory disorders limiting treatment application.
- Having a rheumatic disease (except osteoarthritis).
- Osteoporosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, Sarıyer
About this study
This study aimed to investigate the effects of thoracic chiropractic manipulations on pain intensity, depression levels, sleep, and quality of life in women diagnosed with fibromyalgia. The research included 50 female participants aged 25-45 who had been diagnosed with fibromyalgia between 2022 and 2023 at Şişli Hamidiye Etfal Education and Research Hospital. The participants were randomly divided into two groups: a chiropractic treatment group and a control group. Both groups completed pre-treatment assessments using the Visual Analog Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36). The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations. A week after the final session, all participants completed the assessments again.
- Conditions
- Fibromyalgia
- Being tested
- chiropractic manipulation, sham manipulation
- Keywords
- Chiropractic, Thoracic Region, Pain, Quality of Life, Depression, Sleep
- Medical subject headings
- Fibromyalgia, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chiropractic manipulationOther
Chiropractic manipulation is a manual therapy technique commonly used by chiropractors. It involves the application of controlled, sudden force to a specific joint, often with the goal of improving joint function, reducing pain, and promoting overall musculoskeletal health.In the context of thoracic chiropractic manipulation, the chiropractor focuses on the vertebrae and joints in the thoracic spine.
sham manipulationOther
Sham manipulation refers to a simulated or placebo form of a manual therapy intervention, often used in research studies, especially in clinical trials involving chiropractic or physical therapy. the term "sham manipulation" likely implies a procedure that mimics the physical aspects of a real chiropractic manipulation but does not involve the actual therapeutic forces or movements.
The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Other: chiropractic manipulation |
| Control Group | Sham comparator | Not described Receives: Other: sham manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VİSUAL PAİN SCALE
he "Visual Pain Scale" is a method used to assess and quantify pain intensity through a visual representation. It typically consists of a line or numerical scale accompanied by descriptive labels or facial expressions that reflect different levels of pain severity. Participants are asked to point to or select the position on the scale that best corresponds to their perceived level of pain.
Measured: before the treatment and one week after the treatment.
Secondary outcomes (3)
Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a self-report questionnaire designed to assess the severity of depression symptoms in individuals.The inventory consists of 21 multiple-choice questions, each corresponding to a specific symptom of depression. Individuals are asked to select the statement that best describes their feelings over the past two weeks, including the day of the assessment. The responses are scored on a scale ranging from 0 to 3, with higher scores indicating more severe depressive symptoms. The total score can be interpreted to assess the overall level of depression, typically categorized as minimal (0-13), mild (14-19), moderate (20-28), or severe (29-63).
Measured: before the treatment and one week after the treatment.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire comprising 19 items, grouped into seven components, to assess various aspects of sleep quality and disturbances. Higher scores indicating poorer sleep quality.
Measured: before the treatment and one week after the treatment.
Short Form-36
The Short Form 36 (SF-36) is a widely used questionnaire designed to assess an individual's health-related quality of life. It consists of 36 items covering eight health domains, including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Measured: before the treatment and one week after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jul 2023
- Primary completion1 Jul 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELİF OKATAN, Bahçeşehir University
- Investigators
- Jülide ÖNCÜ ALPTEKİN, Professor Doctor, Study director, Şişli Hamidiye Etfal Training and Research HospitalHasan Kerem ALPTEKİN, Professor Doctor, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194942
- Sponsor's protocol ID
- BAU-FTR-EO-01
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126.
PubMed 22131791Wolfe F, Walitt B, Perrot S, Rasker JJ, Hauser W. Fibromyalgia diagnosis and biased assessment: Sex, prevalence and bias. PLoS One. 2018 Sep 13;13(9):e0203755. doi: 10.1371/journal.pone.0203755. eCollection 2018.
PubMed 30212526Heidari F, Afshari M, Moosazadeh M. Prevalence of fibromyalgia in general population and patients, a systematic review and meta-analysis. Rheumatol Int. 2017 Sep;37(9):1527-1539. doi: 10.1007/s00296-017-3725-2. Epub 2017 Apr 26.
PubMed 28447207
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF CHIROPRACTIC THORACIC MANIPULATION ON PAIN, DEPRESSION, SLEEP AND QUALITY OF LIFE IN PATIENTS WITH FIBROMYALGIA
- ClinicalTrials.gov ID
- NCT06194942
- Acronym / sponsor ID
- BAU-FTR-EO-01
- Conditions
- Fibromyalgia
- Keywords
- Chiropractic, Thoracic Region, Pain, Quality of Life, Depression, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 8 Jan 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.
This study aimed to investigate the effects of thoracic chiropractic manipulations on pain intensity, depression levels, sleep, and quality of life in women diagnosed with fibromyalgia. The research included 50 female participants aged 25-45 who had been diagnosed with fibromyalgia between 2022 and 2023 at Şişli Hamidiye Etfal Education and Research Hospital. The participants were randomly divided into two groups: a chiropractic treatment group and a control group. Both groups completed pre-treatment assessments using the Visual Analog Scale (VAS), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), and Short Form 36 (SF-36). The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations. A week after the final session, all participants completed the assessments again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: chiropractic manipulation |
| Control Group | Sham comparator | Other: sham manipulation |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Having been diagnosed with fibromyalgia by a doctor.
- Having good cognitive status.
- Willingness to participate in the study voluntarily.
- Being a female aged between 25 and 45.
- The symptoms persisting without any degree of improvement or decrease recently.
Key exclusion criteria (12 listed)
- Receiving any non-pharmacological treatment.
- Having heart, kidney, or liver failure.
- Having inflammatory, psychiatric, neurological, and/or chronic progressive systemic diseases.
- Pregnancy.
- Having a history of acute or past fractures.
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 |
|---|---|---|
| chiropractic manipulationChiropractic manipulation is a manual therapy technique commonly used by chiropractors. It involves the application of controlled, sudden force to a specific joint, often with the goal of improving joint function, reducing pain, and promoting overall musculoskeletal health.In the context of thoracic chiropractic manipulation, the chiropractor focuses on the vertebrae and joints in the thoracic spine. | Other | Treatment Group |
| sham manipulationSham manipulation refers to a simulated or placebo form of a manual therapy intervention, often used in research studies, especially in clinical trials involving chiropractic or physical therapy. the term "sham manipulation" likely implies a procedure that mimics the physical aspects of a real chiropractic manipulation but does not involve the actual therapeutic forces or movements. The chiropractic treatment group received thoracic chiropractic manipulations (HVLA) twice a week for a total of six sessions over three weeks, while the control group received sham manipulations. | Other | Control Group |
Primary outcome
VİSUAL PAİN SCALE
Time frame: before the treatment and one week after the treatment.
he "Visual Pain Scale" is a method used to assess and quantify pain intensity through a visual representation. It typically consists of a line or numerical scale accompanied by descriptive labels or facial expressions that reflect different levels of pain severity. Participants are asked to point to or select the position on the scale that best corresponds to their perceived level of pain.
3 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: before the treatment and one week after the treatment.
Pittsburgh Sleep Quality Index
Time frame: before the treatment and one week after the treatment.
Short Form-36
Time frame: before the treatment and one week after the treatment.
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 Oct 2024.
- Results publication: PubMed 22131791Sillevis R, Cleland J, Hellman M, Beekhuizen K. Immediate effects of a thoracic spine thrust manipulation on the autonomic nervous system: a randomized clinical trial. J Man Manip Ther. 2010 Dec;18(4):181-90. doi: 10.1179/106698110X12804993427126.
- Results publication: PubMed 30212526Wolfe F, Walitt B, Perrot S, Rasker JJ, Hauser W. Fibromyalgia diagnosis and biased assessment: Sex, prevalence and bias. PLoS One. 2018 Sep 13;13(9):e0203755. doi: 10.1371/journal.pone.0203755. eCollection 2018.
- Results publication: PubMed 28447207Heidari F, Afshari M, Moosazadeh M. Prevalence of fibromyalgia in general population and patients, a systematic review and meta-analysis. Rheumatol Int. 2017 Sep;37(9):1527-1539. doi: 10.1007/s00296-017-3725-2. Epub 2017 Apr 26.
- Studies have demonstrated that manipulation applied to the thoracic region reduces pain and directly affects the functioning of the autonomic nervous system, given the dense connections of the autonomic nervous system in the thoracic region.Link provided by the sponsor.
- the prevalence of Fibromyalgia Syndrome (FMS) is observed to be higher in females compared to malesLink provided by the sponsor.
- Considering the dominance of the female gender, the study has exclusively included female patients in order to restrict gender-related factors and minimize gender-dependent influences.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Jülide ÖNCÜ ALPTEKİN, Professor Doctor study director
Şişli Hamidiye Etfal Training and Research Hospital
Hasan Kerem ALPTEKİN, Professor Doctor study director
Bahçeşehir 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 chiropractic manipulation in people with Fibromyalgia, run by Bahçeşehir 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 7 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 9 Oct 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. Some participants in this study may receive a placebo. 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?
VİSUAL PAİN SCALE (time frame: before the treatment and one week after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194942, which also lists 3 linked publications.
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 Oct 2024.