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Completed

NCT Number: NCT05622487

Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Istanbul, Fatıh, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neural Therapy

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

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

Primary outcomes

  1. Visual Analogue Scale pain (0-10 point).

    Time frame: up to 3 month

    Higher scores mean a worse outcome

  2. Fibromyalgia Impact Questionnaire (0-100 point)

    Time frame: up to 3 month

    The Fibromyalgia Impact Questionnaire was developed to assess the current functional status of women with FMS. Higher scores mean a worse outcome

  3. Pain measurement with manual algometer

    Time frame: up to 3 month

    18 tender points in 1990 ACR FMS criteria will be evaluated with a manual algometer. Higher scores mean a worse outcome

Secondary outcomes

  1. Beck Depression Inventory (0-63 point)

    Time frame: up to 3 month

    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

  2. Beck Anxiety Inventory (0-63 point)

    Time frame: up to 3 month

    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

  3. Central Sensitisation Inventory (0-100 point)

    Time frame: up to 3 month

    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

  4. Health Assessment Questionnaire (0-60 point)

    Time frame: up to 3 month

    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

  5. Short Form-36 (0-100 point)

    Time frame: up to 3 month

    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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 18, 2022
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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