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出境医 / 临床实验 / Effectiveness of Neural Therapy in Patients With Fibromiyalgia

Effectiveness of Neural Therapy in Patients With Fibromiyalgia

Study Description
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Procedure: neural therapy Device: Physical Therapy Not Applicable

Detailed Description:

Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep disturbance, and tenderness on palpation at trigger points in the musculoskeletal system.

Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in women than men. Although pharmacological and non-pharmacological approaches play a role in the treatment of the disease, the interest in non-pharmacological therapies has recently increased. In several studies, it has been shown that almost every fibromyalgia patient has applied at least one alternative and complementary medicine method such as Qigong, Tai Chi, yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy.

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Neural Therapy in Patients With Fibromiyalgia
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : April 20, 2019
Actual Study Completion Date : May 14, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Neural Therapy & home exercise program

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
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.

Experimental: Physical Therapy & home exercise program

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
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.

Outcome Measures
Primary Outcome Measures :
  1. Visual analog scale for pain [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Fibromyalgia Impact Questionnaire [ Time Frame: 4 weeks ]
    The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia that contains the dimensions physical functioning (11 items), well-being (1 item), work situation (2 items), pain (1 item), fatigue /sleep (2 items), stiffness (2 items) and psychological symptoms (2 items). Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.

  2. Short- form health survey 36 scores [ Time Frame: 4 weeks ]
    Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female sex
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations
Layout table for location information
Turkey
Tuğba Atan
Çorum, Turkey, 19100
Sponsors and Collaborators
Hitit University
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE January 20, 2019
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
Visual analog scale for pain [ Time Frame: 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Visual analog scale for pain (VAS- pain) [ Time Frame: 4 weeks ]
Pain intensity was measured with visual analogue scale (0-10mm) which is used to measure musculoskeletal pain with very good reliability and validity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Fibromyalgia Impact Questionnaire [ Time Frame: 4 weeks ]
    The Fibromyalgia Impact Questionnaire was designed to measure the health status of patients with fibromyalgia that contains the dimensions physical functioning (11 items), well-being (1 item), work situation (2 items), pain (1 item), fatigue /sleep (2 items), stiffness (2 items) and psychological symptoms (2 items). Total score range from 0 to 100, with higher scores indicating higher levels of symptoms and severity.
  • Short- form health survey 36 scores [ Time Frame: 4 weeks ]
    Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 4 weeks ]
    The FIQ was designed to measure the health status of patients with fibromyalgia.
  • Short- form health survey 36 (SF-36) scores [ Time Frame: 4 weeks ]
    Short- form health survey 36 contains 36 items which are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Neural Therapy in Patients With Fibromiyalgia
Official Title  ICMJE Effectiveness of Neural Therapy in Patients With Fibromiyalgia
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.
Detailed Description

Fibromyalgia is a chronic disease characterized by widespread body pain, fatigue, sleep disturbance, and tenderness on palpation at trigger points in the musculoskeletal system.

Fibromyalgia prevalence is reported between 3% and 9%, and is three times more common in women than men. Although pharmacological and non-pharmacological approaches play a role in the treatment of the disease, the interest in non-pharmacological therapies has recently increased. In several studies, it has been shown that almost every fibromyalgia patient has applied at least one alternative and complementary medicine method such as Qigong, Tai Chi, yoga, mind body interventions, acupuncture, hydrotherapy, balneotherapy or phytotherapy.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Procedure: neural therapy
    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.
  • Device: Physical Therapy
    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.
Study Arms  ICMJE
  • Experimental: Neural Therapy & home exercise program

    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.

    Intervention: Procedure: neural therapy
  • Experimental: Physical Therapy & home exercise program

    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.

    Intervention: Device: Physical Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2019)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 14, 2019
Actual Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • History of comorbid inflammatory rheumatic/ connective tissue diseases
  • History of cardiovascular or musculoskeletal problems that could prevent them to participate in an exercise program
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female sex
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007172
Other Study ID Numbers  ICMJE 2019-114
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tuğba Atan, Hitit University
Study Sponsor  ICMJE Hitit University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hitit University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP