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Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.

Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03740451
Enrollment
50
Registered
2018-11-14
Start date
2018-11-05
Completion date
2019-05-31
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Manual Therapy

Keywords

Fibromyalgia, Manual Therapy, Autonomic Nervous System, Pain, Psychological well-being

Brief summary

Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.

Detailed description

Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality. This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia. The authors expect a stronger decrease in the sympathetic nervous system activation; a greater reduction in pain, and a bigger improvement in well-being and anxiety in those patients treated with active mobilization of soft tissues than passive mobilization group.

Interventions

OTHERActive mobilization of soft tissues

This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.

This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.

Sponsors

Universidad Francisco de Vitoria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Patients will be divided randomly into 3 groups, using the website www.random.org.

Intervention model description

A randomized clinical trial will be conducted where patients will be divided randomly, through the website www.random.org, in three groups: 2 of them will be the experimental group and the other one will be the control group.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia

Exclusion criteria

* Smokers, blood pressure superior to 160/100 mm/Hg, coronary artery disease, peripheral vascular disease, presence of Diabetes I or II, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.

Design outcomes

Primary

MeasureTime frameDescription
Change in Heart rate variability10 minutes (before, during and after intervention)Heart rate variability (HRV) will be assessed as an indicator of autonomic regulation. The HRV measurement will be made through the Elite HRV application, using the value of rMSSD.

Secondary

MeasureTime frameDescription
Pain assessed by the numerical rating scale (NRS)10min (before and after intervention)Pain will be assessed by the numerical rating scale (NRS)
Psychological well-being1 week (just before intervention, 1 week after intervention)Psychological well-being will be assessed by the Ryff scale

Contacts

Primary ContactGabriele Bertotti, B.Sc.
gabriele.bertotti@ufv.es0034622199937
Backup ContactUniversidad Francisco de Vitoria
0034913 51 03 03

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026