Clinical trial NCT05622487: Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Neural Therapy
Kinesio Taping
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analogue Scale pain (0-10 point).
timeFrame: up to 3 month
measure: Fibromyalgia Impact Questionnaire (0-100 point)
timeFrame: up to 3 month
measure: Pain measurement with manual algometer
timeFrame: up to 3 month
Secondary outcomes:
measure: Beck Depression Inventory (0-63 point)
timeFrame: up to 3 month
measure: Beck Anxiety Inventory (0-63 point)
timeFrame: up to 3 month
measure: Central Sensitisation Inventory (0-100 point)
timeFrame: up to 3 month
measure: Health Assessment Questionnaire (0-60 point)
timeFrame: up to 3 month
measure: Short Form-36 (0-100 point)
timeFrame: up to 3 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
state: Fatıh
city: İstanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Study Director
name: Ayşegül Ketenci, Professor
role: PRINCIPAL_INVESTIGATOR
References: