Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-01-26
2021-10-26
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Spinal Manipulation Group
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.
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.
Sham Manipulation Group
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.
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.
No Intervention Group
These patients will receive only their pharmacological treatments.
No interventions assigned to this group
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having been receiving pharmacological treatment for fibromyalgia for at least 2 weeks
* VAS pain score\> 4
Exclusion Criteria
* 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…).
18 Years
55 Years
FEMALE
No
Sponsors
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Bezmialem Vakif University
OTHER
Responsible Party
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Bugra Ince
MD Bugra Ince
Principal Investigators
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Bugra Ince, MD
Role: PRINCIPAL_INVESTIGATOR
Bezmialem Vakif University
Locations
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Bezmialem Vakif University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Ince B, Kara M, Erdem I, Yurdakul OV, Erden T, Aydin T. Effectiveness of spinal manipulation in addition to pharmacological treatment in fibromyalgia: A blinded randomized trial. PM R. 2023 Mar;15(3):342-351. doi: 10.1002/pmrj.12953. Epub 2023 Feb 16.
Other Identifiers
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BI031220
Identifier Type: -
Identifier Source: org_study_id