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Study of the Influence of POLD Manual Therapy in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03939416
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Universitat de Lleida
Information provided by (Responsible Party):
JUAN V. LOPEZ DIAZ, Omphis Foundation

Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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.
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • 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.
  • Level of Pain 1 [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
    Analog visual pain scale (VAS)
  • Quality of pain [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
    MCGILL pain questionnaire
  • Pain interferences [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks. ]
    Brief Pain Inventory (BPI)
Change History Complete list of historical versions of study NCT03939416 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Influence of POLD Manual Therapy in Fibromyalgia
Official Title  ICMJE Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Other: 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.
    Other Name: POLD concept treatment + standart treatment
  • 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
    Other Name: Standart treatment
Study Arms  ICMJE
  • Experimental: POLD concept treatment
    Patients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment
    Intervention: Other: Experimental
  • Active Comparator: CONTROL
    Patients treated with the standart treatment
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 3, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date October 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03939416
Other Study ID Numbers  ICMJE Pold-fibromyalgia-udl
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JUAN V. LOPEZ DIAZ, Omphis Foundation
Study Sponsor  ICMJE Omphis Foundation
Collaborators  ICMJE Universitat de Lleida
Investigators  ICMJE
Principal Investigator: Carmen Campoy, PHD Universitat se Lleida
Study Director: Juan Vicente López Díaz, PHD Universitat de Lleida
PRS Account Omphis Foundation
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP