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Effectiveness of Spinal Manipulation in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04673058
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Bugra Ince, Bezmialem Vakif University

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: Spinal Manipulation Procedure: Sham Manipulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effectiveness of Spinal Manipulation in Addition to Standard Pharmacological Treatment in Fibromyalgia : A Blinded Randomized Clinical Trial
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 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.
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.
Other Name: high velocity low amplitude thrust manipulation

Sham Comparator: 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.
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.

No Intervention: No Intervention Group
These patients will receive only their pharmacological treatments.



Primary Outcome Measures :
  1. Change from Baseline Pain Intensity at 1 and 3 months [ Time Frame: Baseline, one week after the last treatment session (1st month) and 3rd month ]
    Patients will be asked to mark their pain on the visual analog scale (VAS) during each visits.


Secondary Outcome Measures :
  1. Change from Baseline Tenderness (tender point pain threshold score) at 1 and 3 months [ Time Frame: Baseline, one week after the last treatment session (1st month) and 3rd month ]
    Pressure pain threshold of 18 points specified in 1990 American Collage of Rheumatology (ACR) Fibromyalgia classification criteria will be evaluated with The Lafayette Manual Muscle Tester Model 01165 (Lafayette Instrument Company, Lafayette IN, USA). This device is a dynamometer. It has been shown that if circumference is used instead of area as the correction coefficient hand dynamometers with wider tips than standard algometers are also valid and reliable in the pressure pain threshold measurement. The Lafayette Hand-Held Dynamometer uses a tip with a circumference of 5.65 cm. The applied force (kg) / 5.65 will be used as the pressure pain threshold unit in the study. The arithmetic mean of the data obtained from 18 points will be recorded as the tender point pain threshold score.

  2. Change from Baseline Revised Fibromyalgia Impact Questionnaire (FIQR) at 1 and 3 months [ Time Frame: Baseline, one week after the last treatment session (1st month) and 3rd month ]
    FIQR consists of 3 domains. The first domain contains 9 questions that can be scored between 0 and 10 and the score of the physical function is found by dividing the total score by three. Second domain contains 2 questions and the overall impact score is the sum of the scores from these two questions. Third domain consists of 10 questions and symptom score is obtained by dividing the total score by two. Total FIQR score is the sum of 3 domain points.

  3. Change from Baseline Pain Extent at 1 and 3 months [ Time Frame: Baseline, one week after the last treatment session (1st month) and 3rd month ]
    The extent of the pain will be evaluated by widespread pain index (WPI). The WPI quantifies the extent of bodily pain on a 0-19 scale by asking patients if they have had pain or tenderness in 19 different body regions (shoulder girdle, hip, jaw, upper arm, upper leg, lower arm, and lower leg on each side of the body, as well as upper back, lower back, chest, neck, and abdomen) over the past week, with each painful or tender region scoring 1 point.

  4. Change from Baseline Fibromyalgia Severity Score (FSS) at 1 and 3 months [ Time Frame: Baseline, one week after the last treatment session (1st month) and 3rd month ]

    FSS is the sum of the WPI and symptom severity scale (SSS) scores. SSS consists of two domains. For the first domain, the complaints of fatigue, waking unrefreshed and cognitive symptoms are scored between 0 (no problem) and 3 (life-disturbing problems

    ). For the second domain, headaches, pain or cramps in lower abdomen, and depression are scored between 0 (absent) and 1 (present). The total score gives the SSS score.




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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female Patients
Accepts Healthy Volunteers:   No
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…).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673058


Contacts
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Contact: Bugra Ince, MD +905358187951 bugra.ince@hotmail.com
Contact: Mert Kara, MD +905385085985 mkara1@bezmialem.edu.tr

Locations
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Turkey
Bezmialem Vakif University Hospital Recruiting
Istanbul, Turkey
Contact: Bugra Ince, MD    +905358187951    bince@bezmialem.edu.tr   
Sponsors and Collaborators
Bezmialem Vakif University
Investigators
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Principal Investigator: Bugra Ince, MD Bezmialem Vakif University
Publications:
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Responsible Party: Bugra Ince, MD Bugra Ince, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04673058    
Other Study ID Numbers: BI031220
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing will be done on request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bugra Ince, Bezmialem Vakif University:
fibromyalgia
manipulation
manual therapy
spinal
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases