Study of the Influence of POLD Manual Therapy in Fibromyalgia

NCT ID: NCT03939416

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-30

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)

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

POLD concept treatment

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

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

STANDART

1. Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.

2. Sophrology: mental control of insomnia and painful perception

3. Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease

POLD

1. Rhythmic transversal muscle mobilization in posterior chain musculature.

2. General vertebral decompression from the sacrum and pelvis

3. Metameric subcutaneous mobilization

4. Rhythmic vertebral mobilization from the spinous processes.

CONTROL

Patients treated with the standart treatment

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

STANDART

1. Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.

2. Sophrology: mental control of insomnia and painful perception

3. Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease

Interventions

Experimental

STANDART

1. Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.

2. Sophrology: mental control of insomnia and painful perception

3. Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease

POLD

1. Rhythmic transversal muscle mobilization in posterior chain musculature.

2. General vertebral decompression from the sacrum and pelvis

3. Metameric subcutaneous mobilization

4. Rhythmic vertebral mobilization from the spinous processes.

Intervention Type: OTHER

Control

STANDART

1. Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.

2. Sophrology: mental control of insomnia and painful perception

3. Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease

Intervention Type: OTHER

Other Intervention Names

POLD concept treatment + standart treatment; Standart treatment

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat de Lleida

OTHER

Sponsor Role: collaborator

Omphis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Juan Vicente, López Díaz

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmen Campoy, PHD

Role: PRINCIPAL_INVESTIGATOR

Universitat se Lleida

Juan Vicente López Díaz, PHD

Role: STUDY_DIRECTOR

Universitat de Lleida

Locations

Specialized hospital unit of fibromyalgia and SD of conical fatigue of L'Hospital Universitari de Santa María (GSS)

Lleida, Catalonia, Spain

Countries

Spain

Other Identifiers

Pold-fibromyalgia-udl

Identifier Type: -

Identifier Source: org_study_id