Study of the Influence of POLD Manual Therapy in Fibromyalgia

NCT03939416 | Withdrawn DMC

• 1 other identifier: Pold-fibromyalgia-udl
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Chronic pain

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

POLD concept treatment

EXPERIMENTAL

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

Other: Experimental

CONTROL

ACTIVE COMPARATOR

Patients treated with the standart treatment

Other: Control

Interventions

Experimental 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.

Also known as: POLD concept treatment + standart treatment

POLD concept treatment

Control 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

Also known as: Standart treatment

CONTROL

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Omphis Foundation: lead
• Universitat de Lleida: collaborator

Study Sites (1)

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

Lleida, Catalonia, 25198, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carmen Campoy, PHD

  Universitat se Lleida

  PRINCIPAL INVESTIGATOR

• Juan Vicente López Díaz, PHD

  Universitat de Lleida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 6, 2019
• Study Start: July 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

ES (1)