Clinical trial NCT03939416: Study of the Influence of POLD Manual Therapy in Fibromyalgia
Official title: Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Chronic pain
Lead sponsor: Omphis Foundation
Sponsor class: OTHER
Collaborators: name: Universitat de Lleida
First posted: 2019-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical research aims to study the effects of the introduction of POLD manual therapy within the protocol of fibromyalgia

Detailed description: This research project aims to generate scientific evidence on the clinical results obtained in the treatment of fibromyalgia, which usually presents with pain and long-term disability, by applying a special form of manual physiotherapy called "POLD concept". This therapy is based on a passive, oscillatory mobilization, performed at a resonance frequency and applied throughout the time of the therapeutic session, on the vertebrae and the muscles of the back, without interruption. It is carried out on the initiative of the research team in "pain treatment", of the physiotherapy school of the University of Lleida, in collaboration with the Omphis Foundation and the clinical service of the Unity of Fibromyalgia of GSS (Hospital Universitarios de Santa María, Lleida)

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with Fibromyalgia
2. Patients over 25 years old and up to 65 years old, regardless of whether they are women or men.
3. Patients who present pain with a minimum value of 5 on the numerical pain scale from 0 to 10, at the time of beginning the study.
4. Presence of these symptoms in a long period (more than 6 months)

Exclusion Criteria:

1. Patients with a recent traumatic history.
2. Presence of an irradiation component of neurological origin to upper or lower limbs
3. Patients with neurological alterations, both central and peripheral.
4. Patients who are taking opioid-based analgesic medication.
5. Patients with severe spinal malformations.
6. That they are following any other type of treatment, whether manual or physical agents or alternative or complementary therapies.
7. That they have been treated with infiltrations or similar in a period of less than one year before beginning the study.
8. Patients with a serious psychiatric history such as schizophrenia or psychopathies.
9. Patients who have vestibular problems that do not tolerate oscillation.
10. Patients with heart failure
11. Existence of judicial process of disability

Primary outcomes:
measure: Demographic data
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
measure: Level of Pain: VAS
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
measure: Quality of pain: The Mc Gill pain questionnaire
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
measure: Pain interference: We use the Brief Pain Inventory
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Specialized hospital unit of fibromyalgia and SD of conical fatigue of L'Hospital Universitari de Santa María (GSS)
state: Catalonia
Study officials:
affiliation: Universitat se Lleida
name: Carmen Campoy, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitat de Lleida
name: Juan Vicente López Díaz, PHD
role: STUDY_DIRECTOR
References: