Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

NCT ID: NCT05622487

Last Updated: 2022-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-01-01

Brief Summary

The aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.

Detailed Description

Fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. Neural therapy and kinesio taping are treatments for musculoskeletal diseases. In this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. Eligible participants will be randomly assigned to one of two groups using computer generated random numbers. Segmental neural therapy and sham kinesio taping will be applied to the first group. In the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. Treatments will be applied once a week for a total of 6 weeks. Both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. During the follow-up period, patients will be asked not to make changes to their current medical treatment. Participants will be evaluated for pain by Visual Analogue Scale (VAS), Fibromyalgia Impact Questionnaire (FIQ), Central Sensitisation Inventory (CSI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Health Assessment Questionnaire (HAQ), Short Form-36 (SF-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Neural Therapy

Segmental neural therapy will be administered with intradermal 0.5% lidocaine from cervical 1st to sacral 1st vertebra and upper trapezius region with quaddel injections.. Sham kinesio taping will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day.

Group Type: ACTIVE_COMPARATOR

Neural Therapy

Intervention Type: OTHER

Neural therapy is a form of treatment that aims to act on the autonomic nervous system, by injecting local anesthetics into certain parts of the body.

Kinesio Taping

Kinesio taping will be applied with muscle inhibition technique by stretching from the origin to the insertion of the upper trapezius, cervical thoracic and lumbar paravertebral muscles. Sham neural therapy will be applied to the bilateral arms of the patients. Home exercise program; trapezius stretching, cervical, thoracic and lumbar paravertebral muscle stretching exercises will be required to be performed 10 times and every day.

Group Type: ACTIVE_COMPARATOR

Kinesio taping

Intervention Type: OTHER

Kinesiotape is used for injury prevention, rehabilitation and performance enhancement. It has been shown to be clinically effective in increasing joint movements, increasing muscle activity, inducing muscle maximum torque earlier, and improving functional performance

Interventions

Neural Therapy

Neural therapy is a form of treatment that aims to act on the autonomic nervous system, by injecting local anesthetics into certain parts of the body.

Intervention Type: OTHER

Kinesio taping

Kinesiotape is used for injury prevention, rehabilitation and performance enhancement. It has been shown to be clinically effective in increasing joint movements, increasing muscle activity, inducing muscle maximum torque earlier, and improving functional performance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To be diagnosed with fibromyalgia according to the ACR 2016 diagnostic criteria.
• Being a woman between the ages of 18 and 55.
• No change in the medical treatment he received for fibromyalgia syndrome during the study
• To be able to come to treatment 1 day a week for 6 weeks

Exclusion Criteria

• Presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit
• Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
• Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
• Uncontrolled hypertension and uncontrolled diabetes
• Be in major depression
• Cognitive impairment that causes difficulty following simple commands
• Pregnancy
• Be in menopause
• Allergy to local anesthetics and kinesio taping
• Open wound or infection at the application site

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Sinan GOK

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşegül Ketenci, Professor

Role: PRINCIPAL_INVESTIGATOR

Study Director

Locations

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, Fatıh, Turkey (Türkiye)

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Istanbul Universty FMS

Identifier Type: -

Identifier Source: org_study_id