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

NCT03740451 | Unknown

• 1 other identifier: MTonANS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibromyalgia, Manual Therapy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain assessed by the numerical rating scale (NRS)

  10min (before and after intervention)

• Psychological well-being

  1 week (just before intervention, 1 week after intervention)

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Active mobilization of soft tissues

Other: Active mobilization of soft tissues

Experimental group 2

EXPERIMENTAL

Passive mobilization

Other: Passive mobilization

Control group

NO INTERVENTION

No intervention

Interventions

Active mobilization of soft tissues OTHER

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.

Experimental group 1

Passive mobilization OTHER

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.

Experimental group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead

MeSH Terms

Conditions

Fibromyalgia; Pain; Psychological Well-Being

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Central Study Contacts

Gabriele Bertotti, B.Sc.

CONTACT

0034622199937; gabriele.bertotti@ufv.es

Universidad Francisco de Vitoria

CONTACT

0034913 51 03 03

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients will be divided randomly into 3 groups, using the website www.random.org.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 14, 2018
• Study Start: November 5, 2018
• Primary Completion: March 31, 2019
• Study Completion: May 31, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11