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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05622487
Other study ID # Istanbul Universty FMS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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