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Trial record 33 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Effectiveness of Neural Therapy in Patients With Fibromiyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007172
Recruitment Status : Completed
First Posted : July 3, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Tuğba Atan, Hitit University

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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.




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).



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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

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): NCT04007172


Locations
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Turkey
Tuğba Atan
Çorum, Turkey, 19100
Sponsors and Collaborators
Hitit University

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Responsible Party: Tuğba Atan, Assoc. Prof., Hitit University
ClinicalTrials.gov Identifier: NCT04007172     History of Changes
Other Study ID Numbers: 2019-114
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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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 Tuğba Atan, Hitit University:
neural therapy
physical theraphy
lidocain injection
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nervous System Diseases
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action