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Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neural Therapy
Kinesio taping
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Neural Therapy, Kinesio Taping

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Neural Therapy

Kinesio Taping

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale pain (0-10 point).
Higher scores mean a worse outcome
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
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

Secondary Outcome Measures

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
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
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
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
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

Full Information

First Posted
August 6, 2022
Last Updated
November 14, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05622487
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Neural Therapy, Kinesio Taping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neural Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Kinesio Taping
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Neural Therapy
Intervention Description
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
Intervention Name(s)
Kinesio taping
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scale pain (0-10 point).
Description
Higher scores mean a worse outcome
Time Frame
up to 3 month
Title
Fibromyalgia Impact Questionnaire (0-100 point)
Description
The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome
Time Frame
up to 3 month
Title
Pain measurement with manual algometer
Description
18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome
Time Frame
up to 3 month
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (0-63 point)
Description
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
Time Frame
up to 3 month
Title
Beck Anxiety Inventory (0-63 point)
Description
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
Time Frame
up to 3 month
Title
Central Sensitisation Inventory (0-100 point)
Description
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
Time Frame
up to 3 month
Title
Health Assessment Questionnaire (0-60 point)
Description
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
Time Frame
up to 3 month
Title
Short Form-36 (0-100 point)
Description
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
Time Frame
up to 3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşegül Ketenci, Professor
Organizational Affiliation
Study Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
City
Istanbul
State/Province
Fatıh
ZIP/Postal Code
34034
Country
Turkey
Facility Name
Istanbul University
City
İstanbul
ZIP/Postal Code
3409
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

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