Clinical trial NCT04673058: Effectiveness of Spinal Manipulation in Fibromyalgia
Official title: Effectiveness of Spinal Manipulation in Addition to Standard Pharmacological Treatment in Fibromyalgia : A Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
manipulation
manual therapy
spinal
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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...).

Primary outcomes:
measure: Change from Baseline Pain Intensity at 1 and 3 months
timeFrame: Baseline, one week after the last treatment session (1st month) and 3rd month
Secondary outcomes:
measure: Change from Baseline Tenderness (tender point pain threshold score) at 1 and 3 months
timeFrame: Baseline, one week after the last treatment session (1st month) and 3rd month
measure: Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQR) at 1 and 3 months
timeFrame: Baseline, one week after the last treatment session (1st month) and 3rd month
measure: Change from Baseline Pain Extent at 1 and 3 months
timeFrame: Baseline, one week after the last treatment session (1st month) and 3rd month
measure: Change from Baseline Fibromyalgia Severity Score (FSS) at 1 and 3 months
timeFrame: Baseline, one week after the last treatment session (1st month) and 3rd month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University Hospital
Study officials:
affiliation: Bezmialem Vakif University
name: Bugra Ince, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haavik-Taylor H, Murphy B. Cervical spine manipulation alters sensorimotor integration: a somatosensory evoked potential study. Clin Neurophysiol. 2007 Feb;118(2):391-402. doi: 10.1016/j.clinph.2006.09.014. Epub 2006 Nov 29.
citation: Moustafa IM, Diab AA. The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial. Rheumatol Int. 2015 Jul;35(7):1163-74. doi: 10.1007/s00296-015-3248-7. Epub 2015 Mar 18.
citation: Haller H, Lauche R, Sundberg T, Dobos G, Cramer H. Craniosacral therapy for chronic pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2019 Dec 31;21(1):1. doi: 10.1186/s12891-019-3017-y.
citation: Licciardone JC, Brimhall AK, King LN. Osteopathic manipulative treatment for low back pain: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2005 Aug 4;6:43. doi: 10.1186/1471-2474-6-43.
citation: Macfarlane GJ, Kronisch C, Dean LE, Atzeni F, Hauser W, Fluss E, Choy E, Kosek E, Amris K, Branco J, Dincer F, Leino-Arjas P, Longley K, McCarthy GM, Makri S, Perrot S, Sarzi-Puttini P, Taylor A, Jones GT. EULAR revised recommendations for the management of fibromyalgia. Ann Rheum Dis. 2017 Feb;76(2):318-328. doi: 10.1136/annrheumdis-2016-209724. Epub 2016 Jul 4.