Clinical trial NCT05559021: What Concept of Manual Therapy is More Effective?
Official title: What Concept of Manual Therapy is More Effective to Improved Health Status in Women With Fibromyalgia Syndrome?: An Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Self Efficacy
Kinesiophobia
Catastrophizing
Central Sensitisation
Anxiety
Depression
Sleep
Keywords: Manual Therapy
Chronic Pain
Fibromyalgia
Passive Mobilizations
Myofascial Approach
Symptom Severity
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial will be conducted between October 2022 and December 2023 in 52 female patients impacted by Fibromyalgia who will undergo a myofascial treatment approach or mobilization treatment approach , with 3 months of follow-up post-treatment.
Primary purpose: TREATMENT

Brief summary: The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.

Detailed description: A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Eligibility criteria: Inclusion Criteria:

* Less than 62 years old
* Medical Diagnosis of Fibromyalgia
* The individuals included in the study had a minimum one-year history of symptoms
* To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.

The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.

Exclusion Criteria:

* Intolerance to touch
* A change of medication in the last 2-3 months
* Agree not to change their medication during the study

Exclusion Criteria:

-

Primary outcomes:
measure: Pain Expansion
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Symptom severity
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Fibromyalgia Impact Questionnaire
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Secondary outcomes:
measure: kinesiophobia
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Self-Efficacy
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Anxiety
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Depression
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Quality of life (EQ-5D-5L)
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Sleep quality
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
measure: Visual Analog Scale (VAS)
timeFrame: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Eleuterio A. Sánchez Romero
city: Madrid
country: Spain
facility: Universidad Europea de Madrid
Study officials:
affiliation: European University of Madrid
name: Eleuterio A. Sánchez Romero, PhD
role: PRINCIPAL_INVESTIGATOR
References: