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

Not Applicable
Conditions
Fibromyalgia, Manual Therapy
Interventions
Other: Active mobilization of soft tissues
Other: Passive mobilization
Registration Number
NCT03740451
Lead Sponsor
Universidad Francisco de Vitoria
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental group 1Active mobilization of soft tissuesActive mobilization of soft tissues
Experimental group 2Passive mobilizationPassive mobilization
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Psychological well-being1 week (just before intervention, 1 week after intervention)

Psychological well-being will be assessed by the Ryff scale

Pain assessed by the numerical rating scale (NRS)10min (before and after intervention)

Pain will be assessed by the numerical rating scale (NRS)

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