Study of the Influence of POLD Manual Therapy in Fibromyalgia

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Primary Purpose

Status

Suspended

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Experimental

Control

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Chronic pain

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients diagnosed with Fibromyalgia
Patients over 25 years old and up to 65 years old, regardless of whether they are women or men.
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.
Presence of these symptoms in a long period (more than 6 months)

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

POLD concept treatment

CONTROL

Arm Description

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

Patients treated with the standart treatment

Outcomes

Primary Outcome Measures

Demographic data

The following data will be recorded: age, sex, race, children, study start date and final date.

Level of Pain: VAS

We will use the Visual Analog Pain Scale (VAS), consisting of a line of 10 cm, whose left end coincides with the value 0 (absence of pain) and the right end with the value 10 (maximum pain imaginable), without reference marks intemediate The patient will mark a point in the line corresponding to his pain at the time of the test, the measurement of the centimeters from the left edge will indicate the analogical score of his pain between 0 and 10.

Quality of pain: The Mc Gill pain questionnaire

The Mc Gill pain questionnaire comprises 62 descriptors distributed in 15 classes and, in turn, in 3 dimensions (sensory, affective and evaluative). A value of pain is obtained for each dimension: sensory pain intensity (VID (S), affective pain intensity (VID (A)) and evaluative pain intensity (VID (E)) The sensory component is evaluated in 7 subclasses. The patient mark one or no descriptor of each subclass, if he scores 1 he scores 1 and if he does not mark none he scores 0. The score of the VID (S) is obtained adding and will be, therefore, between 0 and 7. The affective dimension includes subclasses 8 to 13 and its score ranges from 0 to 6. The evaluative dimension corresponds to subclass 14 and the score of it will be 0 or 1. From the sum of the three, the total score (VID (T)) is obtained, from 0 to 14. In addition, the current pain intensity (VIA) is scored from subclass 15, the score is 0-no pain, 1-mild, 2-annoying, 3-intense, 4-strong, 5-unbearable.

Pain interference: We use the Brief Pain Inventory

We use the Brief Pain Inventory that gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) do not contribute to the scoring

Secondary Outcome Measures

Full Information

NCT ID

NCT03939416

First Posted

May 2, 2019

Last Updated

March 24, 2023

Sponsor

Omphis Foundation

Collaborators

Universitat de Lleida

1. Study Identification

Unique Protocol Identification Number

NCT03939416

Brief Title

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

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Suspended

Why Stopped

for pandemic covid

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

December 30, 2024 (Anticipated)

Study Completion Date

March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Omphis Foundation

Collaborators

Universitat de Lleida

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Chronic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

POLD concept treatment

Arm Type

Experimental

Arm Description

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

Arm Title

CONTROL

Arm Type

Active Comparator

Arm Description

Patients treated with the standart treatment

Intervention Type

Other

Intervention Name(s)

Experimental

Other Intervention Name(s)

POLD concept treatment + standart treatment

Intervention Description

STANDART Physical exercise: degreed joint mobilization, self muscle elongation and postural correction. Sophrology: mental control of insomnia and painful perception 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 Rhythmic transversal muscle mobilization in posterior chain musculature. General vertebral decompression from the sacrum and pelvis Metameric subcutaneous mobilization Rhythmic vertebral mobilization from the spinous processes.

Intervention Type

Other

Intervention Name(s)

Control

Other Intervention Name(s)

Standart treatment

Intervention Description

STANDART Physical exercise: degreed joint mobilization, self muscle elongation and postural correction. Sophrology: mental control of insomnia and painful perception 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

Primary Outcome Measure Information:

Title

Demographic data

Description

The following data will be recorded: age, sex, race, children, study start date and final date.

Time Frame

Participants will be followed for the duration of treatment application, an expected average of 8 weeks.

Title

Level of Pain: VAS

Description

We will use the Visual Analog Pain Scale (VAS), consisting of a line of 10 cm, whose left end coincides with the value 0 (absence of pain) and the right end with the value 10 (maximum pain imaginable), without reference marks intemediate The patient will mark a point in the line corresponding to his pain at the time of the test, the measurement of the centimeters from the left edge will indicate the analogical score of his pain between 0 and 10.

Time Frame

Participants will be followed for the duration of treatment application, an expected average of 8 weeks.

Title

Quality of pain: The Mc Gill pain questionnaire

Description

The Mc Gill pain questionnaire comprises 62 descriptors distributed in 15 classes and, in turn, in 3 dimensions (sensory, affective and evaluative). A value of pain is obtained for each dimension: sensory pain intensity (VID (S), affective pain intensity (VID (A)) and evaluative pain intensity (VID (E)) The sensory component is evaluated in 7 subclasses. The patient mark one or no descriptor of each subclass, if he scores 1 he scores 1 and if he does not mark none he scores 0. The score of the VID (S) is obtained adding and will be, therefore, between 0 and 7. The affective dimension includes subclasses 8 to 13 and its score ranges from 0 to 6. The evaluative dimension corresponds to subclass 14 and the score of it will be 0 or 1. From the sum of the three, the total score (VID (T)) is obtained, from 0 to 14. In addition, the current pain intensity (VIA) is scored from subclass 15, the score is 0-no pain, 1-mild, 2-annoying, 3-intense, 4-strong, 5-unbearable.

Time Frame

Participants will be followed for the duration of treatment application, an expected average of 8 weeks.

Title

Pain interference: We use the Brief Pain Inventory

Description

We use the Brief Pain Inventory that gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) do not contribute to the scoring

Time Frame

Participants will be followed for the duration of treatment application, an expected average of 8 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients diagnosed with Fibromyalgia Patients over 25 years old and up to 65 years old, regardless of whether they are women or men. 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. Presence of these symptoms in a long period (more than 6 months) Exclusion Criteria: Patients with a recent traumatic history. Presence of an irradiation component of neurological origin to upper or lower limbs Patients with neurological alterations, both central and peripheral. Patients who are taking opioid-based analgesic medication. Patients with severe spinal malformations. That they are following any other type of treatment, whether manual or physical agents or alternative or complementary therapies. That they have been treated with infiltrations or similar in a period of less than one year before beginning the study. Patients with a serious psychiatric history such as schizophrenia or psychopathies. Patients who have vestibular problems that do not tolerate oscillation. Patients with heart failure Existence of judicial process of disability

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carmen Campoy, PHD

Organizational Affiliation

Universitat se Lleida

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Juan Vicente López Díaz, PHD

Organizational Affiliation

Universitat de Lleida

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Lleida

State/Province

Catalonia

ZIP/Postal Code

25198

Country

Spain

Fibromyalgia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial