The EFFECT of CHIROPRACTIC THORACIC MANIPULATION on PAIN, DEPRESSION, SLEEP and QUALITY of LIFE in PATIENTS with FIBROMYALGIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- VİSUAL PAİN SCALE
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Pittsburgh Sleep Quality Index(before the treatment and one week after the treatment.)
- Beck Depression Inventory (BDI)(before the treatment and one week after the treatment.)
- Short Form-36(before the treatment and one week after the treatment.)
Investigators
ELİF OKATAN
Physiotherapist
Bahçeşehir University