Study of the Influence of POLD Manual Therapy in Fibromyalgia

Omphis Foundation

Status: Withdrawn

Conditions: Fibromyalgia

Treatments: Other: Control; Other: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT03939416

Pold-fibromyalgia-udl

Details and patient eligibility

About

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

Full 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)

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

POLD concept treatment

Experimental group

Description:

Patients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment

Treatment:

Other: Experimental

CONTROL

Active Comparator group

Description:

Patients treated with the standart treatment

Treatment:

Other: Control