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临床试验/NCT04673058
NCT04673058已完成不适用

Effectiveness of Spinal Manipulation in Addition to Standard Pharmacological Treatment in Fibromyalgia : A Blinded Randomized Clinical Trial

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change from Baseline Pain Intensity at 1 and 3 months

研究概览

简要总结

The aim of this study is to evaluate whether spinal manipulation, which is a potential treatment method for musculoskeletal pain, has an additional contribution in patients with fibromyalgia receiving standard pharmacological treatment.

详细描述

Although fibromyalgia (FM) is quite common, success rates in conservative treatment are unsatisfying. Combination of pharmacological and non-pharmacological applications is recommended in treatment. Although the etiology of FM is not well known, characteristic findings such as hyperalgesia and allodynia suggest problems related to pain and sensorial processing in the central nervous system.

It has been suggested that spinal manipulation can alter sensorimotor integration in the central nervous system and therefore can be used in the treatment of central sensitization syndromes. However, manual therapy applications, which were examined under the heading of chiropractic in the 2016 EULAR treatment recommendations, were not recommended due to the low quality (open-label, quasi-experimental) of the studies conducted so far. However, it has been suggested for future studies to investigate whether the combined use of pharmacological and non-pharmacological treatments is more effective than single modality management. But since then unfortunately a high level of evidence also could not be obtained related to use of spinal manipulation in FM due to reasons such as lack of reporting of the manual therapy methods used in detail, conducting studies involving mostly soft tissue techniques and not following CONSORT recommendations.

This study is planned as a prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study considering the concepts that have been lacking the literature.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

2 staff members who will administer the treatment to active intervention and sham therapy groups will not be able to be blinded due the inherent of manual therapy. Staff members who are responsible for statistical analysis, participants and outcome assessors will be blinded.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being diagnosed with fibromyalgia according to the 2016 ACR Fibromyalgia Diagnostic Criteria
  • Having been receiving pharmacological treatment for fibromyalgia for at least 2 weeks
  • VAS pain score> 4

排除标准

  • Structural problem of the musculoskeletal system (acute spinal disc herniation, acute spondylolisthesis / lysis, fractures and dislocations, advanced degenerative changes, spinal stenosis)
  • Pregnancy or breastfeeding
  • Inflammatory or infectious disease
  • Malignancy
  • Neuromuscular disease
  • History of spinal surgery
  • Unstable psychiatric disease
  • Previously received manual therapy or having enough information about manual therapy to distinguish between sham and real therapy (researched online, watched videos...).

结局指标

主要结局

Change from Baseline Pain Intensity at 1 and 3 months

时间窗: Baseline, one week after the last treatment session (1st month) and 3rd month

Patients will be asked to mark their pain on the visual analog scale (VAS) during each visits.

次要结局

  • Change from Baseline Pain Extent at 1 and 3 months(Baseline, one week after the last treatment session (1st month) and 3rd month)
  • Change from Baseline Fibromyalgia Severity Score (FSS) at 1 and 3 months(Baseline, one week after the last treatment session (1st month) and 3rd month)
  • Change from Baseline Tenderness (tender point pain threshold score) at 1 and 3 months(Baseline, one week after the last treatment session (1st month) and 3rd month)
  • Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQR) at 1 and 3 months(Baseline, one week after the last treatment session (1st month) and 3rd month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bugra Ince

MD Bugra Ince

Bezmialem Vakif University

研究点 (1)

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