Study of the Influence of POLD Manual Therapy in Fibromyalgia
|ClinicalTrials.gov Identifier: NCT03939416|
Recruitment Status : Enrolling by invitation
First Posted : May 6, 2019
Last Update Posted : May 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Experimental Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Care Provider, Outcomes Assessor)|
|Official Title:||Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Experimental: POLD concept treatment
Patients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment
Other Name: POLD concept treatment + standart treatment
Active Comparator: CONTROL
Patients treated with the standart treatment
Other Name: Standart treatment
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03939416
|Specialized hospital unit of fibromyalgia and SD of conical fatigue of L'Hospital Universitari de Santa María (GSS)|
|Lleida, Catalonia, Spain, 25198|
|Principal Investigator:||Carmen Campoy, PHD||Universitat se Lleida|
|Study Director:||Juan Vicente López Díaz, PHD||Universitat de Lleida|