Study of the Influence of POLD Manual Therapy in Fibromyalgia

Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia

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

Study Overview

• Status: Suspended
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Experimental; Other: Control

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)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Lleida, Catalonia, Spain, 25198
      • Specialized hospital unit of fibromyalgia and SD of conical fatigue of L'Hospital Universitari de Santa María (GSS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POLD concept treatment; Patients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment	Other: Experimental; 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.; Other Names: POLD concept treatment + standart treatment
Active Comparator: CONTROL; Patients treated with the standart treatment	Other: Control; 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; Other Names: Standart treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	The following data will be recorded: age, sex, race, children, study start date and final date.	Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
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.	Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
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.	Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
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	Participants will be followed for the duration of treatment application, an expected average of 8 weeks.

Collaborators and Investigators

• Sponsor: Omphis Foundation
• Collaborators: Universitat de Lleida
• Investigators: Principal Investigator: Carmen Campoy, PHD, Universitat se Lleida; Study Director: Juan Vicente López Díaz, PHD, Universitat de Lleida

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: May 2, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic pain; Fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Pold-fibromyalgia-udl

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No