The EFFECT of CHIROPRACTIC THORACIC MANIPULATION on PAIN, DEPRESSION, SLEEP and QUALITY of LIFE in PATIENTS with FIBROMYALGIA

NCT ID: NCT06194942

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-08-25

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

Group Type EXPERIMENTAL

chiropractic manipulation

Intervention Type OTHER

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.

Control Group

Group Type SHAM_COMPARATOR

sham manipulation

Intervention Type OTHER

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.

Interventions

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chiropractic manipulation

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.

Intervention Type OTHER

sham manipulation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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ELİF OKATAN

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jülide ÖNCÜ ALPTEKİN, Professor Doctor

Role: STUDY_DIRECTOR

Şişli Hamidiye Etfal Training and Research Hospital

Hasan Kerem ALPTEKİN, Professor Doctor

Role: STUDY_DIRECTOR

Bahçeşehir University

Locations

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Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22131791 (View on PubMed)

Wolfe 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.

Reference Type BACKGROUND
PMID: 30212526 (View on PubMed)

Heidari 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.

Reference Type BACKGROUND
PMID: 28447207 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3113268/

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.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136749/

the prevalence of Fibromyalgia Syndrome (FMS) is observed to be higher in females compared to males

https://pubmed.ncbi.nlm.nih.gov/28447207/

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.

Other Identifiers

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BAU-FTR-EO-01

Identifier Type: -

Identifier Source: org_study_id

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