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

Fibromyalgia, Manual Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03740451
• Other study ID #: MTonANS
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: November 2018
• Source: Universidad Francisco de Vitoria
• Contact: Gabriele Bertotti, B.Sc.
• Phone: 0034622199937
• Email: gabriele.bertotti[@]ufv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia, Manual Therapy
• Myofascial Pain Syndromes

Intervention

Other:
• Active 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.
• Passive mobilization
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Francisco de Vitoria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart rate variability	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.	10 minutes (before, during and after intervention)
Secondary	Pain assessed by the numerical rating scale (NRS)	Pain will be assessed by the numerical rating scale (NRS)	10min (before and after intervention)
Secondary	Psychological well-being	Psychological well-being will be assessed by the Ryff scale	1 week (just before intervention, 1 week after intervention)