Effectiveness of Spinal Manipulation in Fibromyalgia

Bezmialem Vakif University

Status: Completed

Conditions: Fibromyalgia

Treatments: Procedure: Spinal Manipulation; Procedure: Sham Manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04673058

BI031220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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...).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Spinal Manipulation Group

Experimental group

Description:

After the patients were evaluated in terms of somatic dysfunction, the appropriate techniques of Cervical Upglide Thrust, Cervical Downglide Thrust, Cervical Traction Thrust, Cervical Rotation Thrust, Cervico-Thoracic Distraction Manipulation, Cervico-Thoracic Lateral Glide (Spinous Push) Manipulation, Supine Screw Thoracic Thrust, Prone Thoracic Thrust, and Lumbar Spine Rotation Manipulation will be applied to patients.

Treatment:

Procedure: Spinal Manipulation

Sham Manipulation Group

Sham Comparator group

Description:

A treatment will be applied which is very similar to active treatment but aimed to have minimal therapeutic effect. For this, 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. In this way, the movement will be imitated without reaching the elastic zone and a stronger similarity will be provided compared to sham treatments such as light touch or massage.

Treatment:

Procedure: Sham Manipulation

No Intervention Group

No Intervention group

Description:

These patients will receive only their pharmacological treatments.