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

NCT06194942 | Completed

• 1 other identifier: BAU-FTR-EO-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Chiropractic, Thoracic Region, Pain, Quality of Life, Depression, Sleep

Outcome Measures

Primary Outcomes (1)

• 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.

  before the treatment and one week after the treatment.

Secondary Outcomes (3)

• Beck Depression Inventory (BDI)

  before the treatment and one week after the treatment.

• Pittsburgh Sleep Quality Index

  before the treatment and one week after the treatment.

• Short Form-36

  before the treatment and one week after the treatment.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Other: chiropractic manipulation

Control Group

SHAM COMPARATOR

Other: sham manipulation

Interventions

chiropractic manipulation 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.

Treatment Group

sham manipulation 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.

Control Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 22131791 BACKGROUND

• 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.

  PMID: 30212526 BACKGROUND

• 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.

  PMID: 28447207 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Fibromyalgia; Pain; Depression

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Jülide ÖNCÜ ALPTEKİN, Professor Doctor

  Şişli Hamidiye Etfal Training and Research Hospital

  STUDY DIRECTOR

• Hasan Kerem ALPTEKİN, Professor Doctor

  Bahçeşehir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 25, 2024
• Last Updated: October 9, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)