Effectiveness of Spinal Manipulation in Fibromyalgia

October 26, 2021 updated by: Bugra Ince, Bezmialem Vakif University

Effectiveness of Spinal Manipulation in Addition to Standard Pharmacological Treatment in Fibromyalgia : A Blinded Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bezmialem Vakif University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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…).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, one week after the last treatment session (1st month) and 3rd month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Baseline, one week after the last treatment session (1st month) and 3rd month
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.
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
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.
Baseline, one week after the last treatment session (1st month) and 3rd month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2021

Primary Completion (Actual)

October 15, 2021

Study Completion (Actual)

October 26, 2021

Study Registration Dates

First Submitted

December 7, 2020

First Submitted That Met QC Criteria

December 12, 2020

First Posted (Actual)

December 17, 2020

Study Record Updates

Last Update Posted (Actual)

October 27, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BI031220

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data sharing will be done on request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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