Study of the Influence of POLD Manual Therapy in Fibromyalgia

• ClinicalTrials.gov Identifier: NCT03939416
• Recruitment Status: Suspended
• First Posted: May 6, 2019
• Last Update Posted: May 26, 2022
• Sponsor: Omphis Foundation
• Collaborator: Universitat de Lleida
• Information provided by (Responsible Party): JUAN V. LOPEZ DIAZ, Omphis Foundation

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Experimental; Other: Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia
• Estimated Study Start Date: September 1, 2022
• Estimated Primary Completion Date: March 30, 2023
• Estimated Study Completion Date: August 30, 2023

Arms and Interventions

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 Name: 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 Name: Standart treatment

Outcome Measures

Primary Outcome Measures :

1. Demographic data [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
   The following data will be recorded: age, sex, race, children, study start date and final date.
2. Level of Pain: VAS [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
   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.
3. Quality of pain: The Mc Gill pain questionnaire [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]

   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.

4. Pain interference: We use the Brief Pain Inventory [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
   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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Spain

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

Lleida, Catalonia, Spain, 25198

Sponsors and Collaborators

Omphis Foundation

Universitat de Lleida

Investigators

• Principal Investigator: Carmen Campoy, PHD; Universitat se Lleida
• Study Director: Juan Vicente López Díaz, PHD; Universitat de Lleida

More Information

• Responsible Party: JUAN V. LOPEZ DIAZ, Director, Omphis Foundation
• ClinicalTrials.gov Identifier: NCT03939416
• Other Study ID Numbers: Pold-fibromyalgia-udl
• First Posted: May 6, 2019
• Last Update Posted: May 26, 2022
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JUAN V. LOPEZ DIAZ, Omphis Foundation:

Fibromyalgia; Chronic pain

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases