Effectiveness of Spinal Manipulation in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Spinal Manipulation; Sham Manipulation
Intervention type(s): Procedure; Procedure
Intervention description(s): Intervention will be administered twice a week for 3 weeks. Each treatment session will be given in 20-minute sessions consisting of 10 minutes of manual examination and 10 minutes of manual treatment.; The practitioner will primarily identify the areas where somatic dysfunction is detected and keep the application away from these areas. The patient will be positioned for treatment as in active therapy, but once in the lock position, a lower thrust will be given by releasing some back from the position.
Other intervention name(s): high velocity low amplitude thrust manipulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, triple-blinding, randomized controlled and 3-arm parallel group design clinical study. 3 arms of the study were planned to consist of active intervention group, sham treatment group and no intervention group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibromyalgia; manipulation; manual therapy; spinal