NCT04007172

Brief Summary

Neural therapy is a regulation therapy that tries to correct this underlying autonomic dysfunction. In neural therapy; local painful areas, trigger points and symptomatic segments are included in the injection using local anesthetics and the underlying disruptive areas are investigated and treated. The aim of this study was to investigate the efficacy of neural therapy in fibromyalgia syndrome which is thought to have a neuroendocrine dysregulation disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2019

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

July 1, 2019

Last Update Submit

July 3, 2019

Conditions

Fibromyalgia

Keywords

neural therapyphysical theraphylidocain injection

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale for pain

    Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

    4 weeks

Secondary Outcomes (2)

  • Fibromyalgia Impact Questionnaire

    4 weeks

  • Short- form health survey 36 scores

    4 weeks

Study Arms (2)

Neural Therapy & home exercise program

EXPERIMENTAL

Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes. Both the groups received education about fibromyalgia and home exercise program, which included stretching, strengthening, and aerobic exercises.

Procedure: neural therapy

Physical Therapy & home exercise program

EXPERIMENTAL

Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders. Both the groups received education about fibromyalgia and home exercise program, which included stretching, strengthening, and aerobic exercises.

Device: Physical Therapy

Interventions

neural therapyPROCEDURE

Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes.

Neural Therapy & home exercise program
Physical TherapyDEVICE

Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders.

Physical Therapy & home exercise program

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale sex
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed according to the American College of Rheumatology 2016 diagnostic criteria for fibromyalgia.

You may not qualify if:

  • History of comorbid inflammatory rheumatic/ connective tissue diseases
  • History of cardiovascular or musculoskeletal problems that could prevent them to participate in an exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Anesthesia, LocalPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaTherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

January 20, 2019

Primary Completion

April 20, 2019

Study Completion

May 14, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

TU(1)