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).
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Fibromyalgia Syndrome
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted28 Jan 2025
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebahat Tekeli Sengul, Uşak University
- Investigators
- professor, Principal investigator, Uşak University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neural Therapy on Heart Rate Recovery, Cardiac Parameters and Pain in Fibromyalgia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06795750
- Acronym / sponsor ID
- Sengul-UsakU
- Conditions
- Fibromyalgia Syndrome
- Keywords
- neural therapy, fibromyalgia, autonomic dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neural therapy and exercise | Experimental | Procedure: neural therapyThe neural therapy group received local injections of 1% lidocaine into the C5-L2 segmental and painful points once a week for 5 weeks. |
| exercise | Experimental | Other: ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Clinical diagnosis of Fibromiyalgia Syndrome
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neural therapyNeural 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 | Procedure or surgery | neural therapy and exercise |
| ExerciseThe 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. | Other | exercise |
Primary outcome
Changes in impaired heart rate recovery
Time frame: From enrollment to the end of treatment at 5 weeks
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).
3 secondary outcomes
Changes in pain levels in fibromiyalgia patients
Time frame: From enrollment to the end of treatment at 5 weeks
Changes in heart rate
Time frame: From enrollment to the end of treatment at 5 weeks
Changes in blood pressure
Time frame: From enrollment to the end of treatment at 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
professor principal investigator
Uşak University
1 site in 1 country: see every site and its status.
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.