The Effect of Neural Therapy on Heart Rate Recovery, Cardiac Parameters and Pain in Fibromyalgia

NCT06795750 | Completed

• 1 other identifier: Sengul-UsakU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Autonomic dysfunction has been observed in patients with fibromyalgia and is associated with symptoms and arrhythmia development in such patients.The investigators can analyze dysautonomia using heart rate recovery (HRR). Studies have reported that impaired HRR improves after exercise in fibromyalgia patients. Although previous theories have suggested that neural therapy benefits fibromyalgia patients by regulating autonomic dysfunction, there are no studies in the literature reporting that neural therapy improves autonomic dysfunction. Aims: The purpose of the present study was to compare whether neural therapy + exercise therapy provided more improvement in impaired HRR, cardiac parameters, and pain levels than exercise alone therapy in fibromyalgia patients with autonomic dysfunction. Methods: The study included sixty female patients diagnosed with fibromyalgia and impaired HRR, all over the age of 18. The investigators divided the patients into two groups: the exercise-alone group and the neural therapy + exercise group.

Conditions

Fibromyalgia Syndrome

Keywords

neural therapy; fibromyalgia; autonomic dysfunction

Outcome Measures

Primary Outcomes (1)

• Changes in impaired heart rate recovery

  Heart rate recovery (HRR) can be calculated by subtracting the heart rate at the 30th second or 1st, 2nd, 3rd, 4th, 5th, and 10th minutes during the post-exercise recovery period from the maximum heart rate during the treadmill exercise test (the most commonly used is the 1st minute \[HRR60 s\] and the 2nd minute \[HRR120\]). An abnormal HRR index was defined as a drop in the heart rate of less than 12 beats in the first minute and 22 beats in the second minute during the resting period (HRR60 s \<12) (HRR120 s \<22).

  From enrollment to the end of treatment at 5 weeks

Secondary Outcomes (3)

• Changes in pain levels in fibromiyalgia patients

  From enrollment to the end of treatment at 5 weeks

• Changes in heart rate

  From enrollment to the end of treatment at 5 weeks

• Changes in blood pressure

  From enrollment to the end of treatment at 5 weeks

Study Arms (2)

neural therapy and exercise

EXPERIMENTAL

The neural therapy group received local injections of 1% lidocaine into the C5-L2 segmental and painful points once a week for 5 weeks.

Procedure: neural therapy

exercise

EXPERIMENTAL

The second group received a home exercise programe consisting of stretching, strengthening, and aerobic exercises for 30 minutes, three times per week, for a duration of five weeks.

Other: Exercise

Interventions

neural therapy PROCEDURE

Neural therapy (NT) is a therapeutic intervention that uses local anesthetics to alleviate persistent musculoskeletal pain. NT targets the underlying autonomic dysfunction by modulating the autonomic nervous system. The enhancement of autonomic dysfunction leads to controlled microcirculation, the elimination of pain mediators, and the attainment of an anti-inflammatory effect. NT focuses on painful regions, specific segments of these areas, and trigger points, encompassing both local and segmental treatment

neural therapy and exercise

Exercise OTHER

The second group received a home exercise program consisting of stretching, strengthening, and aerobic exercises for 30 minutes, three times per week, for a duration of five weeks.

exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Fibromiyalgia Syndrome

You may not qualify if:

• Secondary fibromyalgia syndrome (such as systemic lupus erythematosus, scleroderma, and Sjögren syndrome), those suffering from rheumatic diseases like polymyalgia rheumatica
• Infectious diseases
• Neurological disorders including thyroid dysfunction, neuropathies, myopathies, myositis, and multiple sclerosis
• Allergies to lidocaine and its constituents -Infections, open wounds, or vascular pathologies at the site of application -
• Severe systemic illnesses Significant mental disorders, or serious psychiatric conditions
• Malignancies or anticoaglant usage
• Pregnancies and breastfeeding experiences
• Who underwent physical therapy, rehabilitation, or injection therapy within the last six months
• Smokers (as they might affect the heart rate recovery index),
• alcoholics
• who did regular individual sports

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

Faculty of Medicine Department of Cardiology

Uşak, Merkez, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias

Interventions

Anesthesia, Local; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• professor

  Uşak University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 28, 2025
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)