Neural Therapy and Kinesio Taping Effectiveness in Fibromyalgia

NCT05622487 | Completed

• 1 other identifier: Istanbul Universty FMS
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Neural Therapy; Kinesio Taping

Outcome Measures

Primary Outcomes (3)

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

  Higher scores mean a worse outcome

  up to 3 month

• 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

• 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 Outcomes (5)

• Beck Depression Inventory (0-63 point)

  up to 3 month

• Beck Anxiety Inventory (0-63 point)

  up to 3 month

• Central Sensitisation Inventory (0-100 point)

  up to 3 month

• Health Assessment Questionnaire (0-60 point)

  up to 3 month

• Short Form-36 (0-100 point)

  up to 3 month

Study Arms (2)

Neural Therapy

ACTIVE COMPARATOR

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.

Other: Neural Therapy

Kinesio Taping

ACTIVE COMPARATOR

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.

Other: Kinesio taping

Interventions

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.

Neural Therapy

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

Kinesio Taping

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (2)

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

Istanbul, Fatıh, 34034, Turkey (Türkiye)

Location

Istanbul University

Istanbul, 3409, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ayşegül Ketenci, Professor

  Study Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: November 18, 2022
• Study Start: March 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: January 1, 2022
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

TU (2)