| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Other: Experimental Other: Control | Not Applicable |
| 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 |
| Actual Study Start Date : | March 1, 2021 |
| Estimated Primary Completion Date : | October 30, 2021 |
| Estimated Study Completion Date : | March 30, 2022 |
| 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
POLD
Other Name: POLD concept treatment + standart treatment
|
|
Active Comparator: CONTROL
Patients treated with the standart treatment
|
Other: Control
STANDART
Other Name: Standart treatment
|
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.
| Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Spain | |
| 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 |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 2, 2019 | ||||||
| First Posted Date ICMJE | May 6, 2019 | ||||||
| Last Update Posted Date | March 3, 2021 | ||||||
| Actual Study Start Date ICMJE | March 1, 2021 | ||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| 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 |
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| Condition ICMJE | Fibromyalgia | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||
| Estimated Enrollment ICMJE |
50 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 30, 2022 | ||||||
| Estimated Primary Completion Date | October 30, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| 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 |
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| PRS Account | Omphis Foundation | ||||||
| Verification Date | March 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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