Clinical trial NCT06194942: The EFFECT of CHIROPRACTIC THORACIC MANIPULATION on PAIN, DEPRESSION, SLEEP and QUALITY of LIFE in PATIENTS with FIBROMYALGIA
Official title: The EFFECT of CHIROPRACTIC THORACIC MANIPULATION on PAIN, DEPRESSION, SLEEP and QUALITY of LIFE in PATIENTS with FIBROMYALGIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Chiropractic, Thoracic Region, Pain, Quality of Life, Depression, Sleep
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: VİSUAL PAİN SCALE
timeFrame: before the treatment and one week after the treatment.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: before the treatment and one week after the treatment.
measure: Pittsburgh Sleep Quality Index
timeFrame: before the treatment and one week after the treatment.
measure: Short Form-36
timeFrame: before the treatment and one week after the treatment.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
state: Sarıyer
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Jülide ÖNCÜ ALPTEKİN, Professor Doctor
role: STUDY_DIRECTOR
affiliation: Bahçeşehir University
name: Hasan Kerem ALPTEKİN, Professor Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.