Autonomic Imbalance
Conditions
Keywords
autonomic nervous system, manual therapy, heart rate variability
Brief summary
The activity of the autonomic nervous system has been shown to influence the appearance of symptoms in some diseases such as rheumatoid arthritis, fibromyalgia, or migraine, among others. In the bibliography we find different authors who, through intervention using manual therapy, have demonstrated its effects on the autonomic nervous system, especially on the increase in parasympathetic activity and reduction in sympathetic activity. A clinical trial is proposed to verify these effects.
Detailed description
The aim of the study is to analyse the effects of applying a specific sequence of manual therapy techniques focused on the regulation of the autonomic nervous system. This intervention sequence will be applied in a single intervention. As a result, an immediate increase in parasympathetic activity could occur, measured by different parameters of heart rate variability, heart rate and respiratory rate. If the results confirm the expected effects, this treatment sequence could be used as a therapeutic resource in patients with pathologies whose symptoms may be related to the deregulation of the autonomic nervous system, such as rheumatoid arthritis, migraine or fibromyalgia, among others.
Interventions
PROCEDURESequence of manual therapy techniques
Receive a sequence of manual therapy techniques composed by: suboccipital decompression technique, suboccipital release technique, fourth ventricle compression technique, vagus nerve neurodynamic technique
PROCEDURESimulated manual therapy techniques
Receive a sequence of simulated manual therapy techniques composed by four maneuvers without effect on autonomic nervous system
Sponsors
Universitat Internacional de Catalunya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participants don't know what intervention are they receiving The outcomes assessor don't know the intervention that the participant is receiving
Intervention model description
Treatment group: receive a manual therapy secuence of techniques focus on the autonomic nervous system Simulated group: receive a sequence of simulated manual therapy techniques
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of informed consent * Aged between 18-65
Exclusion criteria
* Regular consumtion of alcohol or illegal drugs * Consumption of medications whose effect acts on the autonomic nervous system (cholinergic agonists and antagonists, or adrenergic agonists and antagonists) * Diagnostic of disease that may affect the activity of the autonomic nervous system or the perception of pain (such as generalized anxiety disorder, fibromyalgia, or chronic fatigue). * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate | At baseline and immediately post-intervention on Day 1 | The investigators will examine the difference between Time 1 and Time 2 and between groups in beats per minute. |
| Change in Root Mean Square of the Successive Differences Between Adjacent RR Intervals (RMSSD) in Heart Rate Variability Index | At baseline and immediately post-intervention on Day 1 | The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by Root mean square of the successive differences between adjacent RR intervals (RMSSD) in heart rate variability index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in High Frequency (HF) Band in Heart Rate Variability Index | At baseline and immediately post-intervention on Day 1 | The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by high frequency (HF) power of heart rate variability derived from spectral analysis, reflecting parasympathetic nervous system activity, expressed in milliseconds squared (ms²), within the 0.15-0.40 Hz frequency band |
| Change in Respiratory Rate | At baseline and immediately post-intervention on Day 1 | The investigators will examine the difference between Time 1 and Time 2 and between groups in breaths per minute. |
Countries
Spain
Contacts
STUDY_DIRECTORCésar Fernández de las Peñas
Universidad Rey Juan Carlos
Participant flow
Recruitment details
One hundred and two participants were assessed for elegibility. Six participants were excluded: two did not meet the inclusion criteria and four did not complete the relaxation period
Pre-assignment details
Two participants were excluded because they did not meet the inclusion criteria. One of them consumed alcohol, and the other, an energy drink.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 12 |
| height | 171 cm STANDARD_DEVIATION 9.17 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 |
Outcome results
None listed