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Completed

NCT Number: NCT04007172

Effectiveness of Neural Therapy in Patients With Fibromiyalgia

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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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tuğba Atan

Çorum, 19100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neural therapy

Procedure

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.

physical therapy

Device

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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