NCT04673058

Effectiveness of Spinal Manipulation in Fibromyalgia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bezmialem Vakif University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
PROCEDURE	Spinal Manipulation	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.
PROCEDURE	Sham Manipulation	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.

Timeline

• Start date: 2021-01-26
• Primary completion: 2021-10-15
• Completion: 2021-10-26
• First posted: 2020-12-17
• Last updated: 2021-10-27

Locations

1 site across 1 country: Turkey (Türkiye)