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临床试验/NCT06194942
NCT06194942已完成不适用

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

Bahçeşehir University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
VİSUAL PAİN SCALE

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

VİSUAL PAİN SCALE

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Bahçeşehir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ELİF OKATAN

Physiotherapist

Bahçeşehir University

研究点 (1)

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