Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
Primary Purpose
Fibromyalgia, Manual Therapy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active mobilization of soft tissues
Passive mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia, Manual Therapy focused on measuring Fibromyalgia, Manual Therapy, Autonomic Nervous System, Pain, Psychological well-being
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Experimental group 1
Experimental group 2
Control group
Arm Description
Active mobilization of soft tissues
Passive mobilization
No intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pain assessed by the numerical rating scale (NRS)
Pain will be assessed by the numerical rating scale (NRS)
Psychological well-being
Psychological well-being will be assessed by the Ryff scale
Full Information
NCT ID
NCT03740451
First Posted
November 6, 2018
Last Updated
November 11, 2018
Sponsor
Universidad Francisco de Vitoria
1. Study Identification
Unique Protocol Identification Number
NCT03740451
Brief Title
Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
Official Title
Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2018 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Francisco de Vitoria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Manual Therapy
Keywords
Fibromyalgia, Manual Therapy, Autonomic Nervous System, Pain, Psychological well-being
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Patients will be divided randomly into 3 groups, using the website www.random.org.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
Active mobilization of soft tissues
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Passive mobilization
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Active mobilization of soft tissues
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Passive mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Heart rate variability
Description
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.
Time Frame
10 minutes (before, during and after intervention)
Secondary Outcome Measure Information:
Title
Pain assessed by the numerical rating scale (NRS)
Description
Pain will be assessed by the numerical rating scale (NRS)
Time Frame
10min (before and after intervention)
Title
Psychological well-being
Description
Psychological well-being will be assessed by the Ryff scale
Time Frame
1 week (just before intervention, 1 week after intervention)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Bertotti, B.Sc.
Phone
0034622199937
Email
gabriele.bertotti@ufv.es
First Name & Middle Initial & Last Name or Official Title & Degree
Universidad Francisco de Vitoria
Phone
0034913 51 03 03
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.
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