Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Effects of Neural Therapy and Kinesio Taping on Pain, Functional Status, and Quality of Life in Fibromyalgia Patients: A Prospective Randomized Double-Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622487
• Other study ID #: Istanbul Universty FMS
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: November 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul
Turkey	Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale pain (0-10 point).	Higher scores mean a worse outcome	up to 3 month
Primary	Fibromyalgia Impact Questionnaire (0-100 point)	The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome	up to 3 month
Primary	Pain measurement with manual algometer	18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome	up to 3 month
Secondary	Beck Depression Inventory (0-63 point)	Beck Depression Inventory (BDI) is a frequently used evaluation criterion as a diagnosis and follow-up parameter in evaluating the state of depression. Higher scores mean a worse outcome	up to 3 month
Secondary	Beck Anxiety Inventory (0-63 point)	The scale aims to determine the frequency and severity of anxiety symptoms experienced by individuals. The highest score that can be obtained from the 21-item scale is 63. Higher scores mean a worse outcome	up to 3 month
Secondary	Central Sensitisation Inventory (0-100 point)	Central sensitization scale; It is a scale used to detect central sensitization conditions such as fibromyalgia, migraine, myofascial pain, temporomandibular disorder. Higher scores mean a worse outcome	up to 3 month
Secondary	Health Assessment Questionnaire (0-60 point)	The health assessment questionnaire shows the extent of the participant's functional ability, is sensitive to change, and is a good predictor of future cost and disability. Higher scores mean a worse outcome	up to 3 month
Secondary	Short Form-36 (0-100 point)	Short Form-36 is one of the commonly used scales in which health concepts such as functional status and well-being are evaluated. This scale examines health in 8 dimensions: physical function, physical role limitations, emotional role limitations, social function, mental health, vitality (energy), pain and general perception of health. Higher scores mean a worse outcome	up to 3 month