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Fibromyalgia SyndromeNCT06795750

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

A study testing neural therapy and Exercise in people with Fibromyalgia Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Fibromyalgia Syndrome
What is being tested?
neural therapy and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2023to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Clinical diagnosis of Fibromiyalgia Syndrome

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Faculty of Medicine Department of Cardiology

    Uşak, Merkez, 64200

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Neural Therapy on Heart Rate Recovery, Cardiac Parameters and Pain in Fibromyalgia: a Randomized Controlled Trial

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.

Read the detailed description

Fibromyalgia is a chronic condition characterized by musculoskeletal pain, exhaustion, sleep disturbances, and tenderness at specific trigger points in the musculoskeletal system. The frequency of fibromyalgia syndrome (FMS) varies between 3% and 6%, with more frequent detection in women. Dysautonomia, a form of autonomic nervous system dysfunction, is present in one-third of patients with fibromyalgia. The heart rate recovery index and/or the head-up tilt table test can diagnose dysautonomia. It may play a central role in the pathogenesis of the disease and explain multiple systemic symptoms.

The investigators calculate heart rate recovery (HRR) 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 investigators see an abnormal HRR index as a sign of autonomic dysfunction, primarily cardiovascular disease, and as a predictor of all-cause mortality, including cardiovascular mortality.

Neural therapy (NT) is a therapeutic intervention that uses local anesthetics to alleviate persistent musculoskeletal pain. NT targets the underlying autonomic dysfunction by changing the autonomic nervous system. This controls microcirculation, gets rid of pain mediators, and reduces inflammation. Numerous European countries, particularly Germany, have used NT, but studies on its effectiveness in fibromyalgia patients are scarce. The present study aims to investigate whether neural therapy improves cardiac parameters and autonomic dysfunction in fibromyalgia patients with dysautonomia and its effect on pain.

The study included sixty female patients diagnosed with fibromyalgia and impaired HRR, all over the age of 18. İnvestigators divided the patients into two groups: the exercise alone group and the neural therapy + exercise group.The study involved patients diagnosed with fibromyalgia who were over 18 years old and consented to participate in neural and exercise therapy. The investigators excluded from the study patients with conditions that could induce secondary fibromyalgia syndrome, rheumatic diseases, infectious diseases, neurological disorders, allergies to lidocaine, infections, open wounds, vascular pathologies, severe systemic illnesses, significant mental disorders, or serious psychiatric conditions. The study also excluded smokers, alcoholics, individuals with known cardiovascular, respiratory, or neurological disorders or musculoskeletal injuries, and those participating in regular competition or individual sports.

The study used a stress ECG test, the Bruce Protocol-based maximum treadmill stress test, to identify patients with significant autonomic dysfunction. The investigators recorded heart rate, systolic blood pressure, and diastolic blood pressure after a 15-minute rest period. The volunteers then exercised on a treadmill at a speed of 5 km/h and 1% incline for the first 5 minutes of warm-up and at the same incline until they reached the maximum heart rate. İnvestigators recorded HR, SBP, and DBP on the 1st, 2nd, 3rd, 4th, 5th, and every 5 minutes until the end of the rest period.

The study divided the group whose HRR decreased by less than 12 beats in the 1st minute and less than 22 beats in the 2nd minute into neural therapy + exercise and exercise alone groups using the closed envelope method. The neural therapy group underwent neural therapy for five weeks at one-week intervals, while the exercise group engaged in a 30-minute home exercise program three times a week for the same duration.

The investigators examined HRR changes, VAS scores, and cardiac parameters in both groups before and after treatment. The investigators investigated whether there was a significant difference between the two groups.

Being tested
neural therapy, Exercise
Keywords
neural therapy, fibromyalgia, autonomic dysfunction
Medical subject headings
Fibromyalgia, Primary Dysautonomias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neural therapyProcedure or surgery

    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

  • ExerciseOther

    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.

Study groups in NCT06795750
Study groupRoleWhat they receive
neural therapy and exerciseExperimentalThe neural therapy group received local injections of 1% lidocaine into the C5-L2 segmental and painful points once a week for 5 weeks.
Receives: Procedure: neural therapy
exerciseExperimentalThe 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.
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From enrollment to the end of treatment at 5 weeks

Secondary outcomes (3)
  1. Changes in pain levels in fibromiyalgia patients

    The pain level was assessed with the Visual Analog Scale (VAS) using a 10-cm ruler. All patients were told that no pain corresponded to 0, the most severe pain to 10, and moderate pain to five points and asked to describe their pain accordingly.

    Measured: From enrollment to the end of treatment at 5 weeks

  2. Changes in heart rate

    Heart rate number of cardiac cycles in beats per min.

    Measured: From enrollment to the end of treatment at 5 weeks

  3. Changes in blood pressure

    BP measurement was performed using the Omron HEM 907 oscillometric monitor (Omron Healthcare) with a cuff size appropriate for the arm. The monitor was programmed such that the cuff did not start to inflate until the participant rested quietly for 5 minutes in a seated position with the arm at the level of the heart.

    Measured: From enrollment to the end of treatment at 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start1 Nov 2023
  3. Primary completion30 Apr 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06795750
Sponsor's protocol ID
Sengul-UsakU
Status last verified
Jan 2025
First submitted
3 Jan 2025
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing neural therapy and Exercise in people with Fibromyalgia Syndrome, run by Uşak University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in impaired heart rate recovery (time frame: From enrollment to the end of treatment at 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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