Effectiveness of Spinal Manipulation in Fibromyalgia

NCT04673058 | Completed

• 1 other identifier: BI031220
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; manipulation; manual therapy; spinal

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Pain Intensity at 1 and 3 months

  Patients will be asked to mark their pain on the visual analog scale (VAS) during each visits.

  Baseline, one week after the last treatment session (1st month) and 3rd month

Secondary Outcomes (4)

• Change from Baseline Tenderness (tender point pain threshold score) at 1 and 3 months

  Baseline, one week after the last treatment session (1st month) and 3rd month

• Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQR) at 1 and 3 months

  Baseline, one week after the last treatment session (1st month) and 3rd month

• Change from Baseline Pain Extent at 1 and 3 months

  Baseline, one week after the last treatment session (1st month) and 3rd month

• Change from Baseline Fibromyalgia Severity Score (FSS) at 1 and 3 months

  Baseline, one week after the last treatment session (1st month) and 3rd month

Study Arms (3)

Spinal Manipulation Group

EXPERIMENTAL

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.

Procedure: Spinal Manipulation

Sham Manipulation Group

SHAM COMPARATOR

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.

Procedure: Sham Manipulation

No Intervention Group

NO INTERVENTION

These patients will receive only their pharmacological treatments.

Interventions

Spinal Manipulation PROCEDURE

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.

Also known as: high velocity low amplitude thrust manipulation

Spinal Manipulation Group

Sham Manipulation PROCEDURE

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.

Sham Manipulation Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female Patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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…).

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 17137836 BACKGROUND

• 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.

  PMID: 25782585 BACKGROUND

• 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.

  PMID: 31892357 BACKGROUND

• 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.

  PMID: 16080794 BACKGROUND

• 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.

  PMID: 27377815 BACKGROUND

• 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.

  PMID: 36695286 DERIVED

MeSH Terms

Conditions

Fibromyalgia

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Bugra Ince, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 2 staff members who will administer the treatment to active intervention and sham therapy groups will not be able to be blinded due the inherent of manual therapy. Staff members who are responsible for statistical analysis, participants and outcome assessors will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Bugra Ince

Model Details: 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.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: January 26, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 26, 2021
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)