FibromyalgiaNCT03939416
Study of the Influence of POLD Manual Therapy in Fibromyalgia
A study testing Experimental in people with Fibromyalgia, run by Omphis Foundation at 1 site in Spain.
Trial summary
This clinical research aims to study the effects of the introduction of POLD manual therapy within the protocol of fibromyalgia Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Experimental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Specialized hospital unit of fibromyalgia and SD of conical fatigue of L'Hospital Universitari de Santa María (GSS)
Lleida, Catalonia, 25198
About this study
Official title: Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia
This clinical research aims to study the effects of the introduction of POLD manual therapy within the protocol of fibromyalgia
Read the 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)
- Conditions
- Fibromyalgia
- Being tested
- Experimental, Control
- Keywords
- Fibromyalgia, Chronic pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called POLD concept treatment + standart treatment
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.
ControlOther
Also called Standart treatment
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
| Study group | Role | What they receive |
|---|---|---|
| POLD concept treatment | Experimental | Patients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment Receives: Other: Experimental |
| CONTROL | Active comparator | Patients treated with the standart treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
The following data will be recorded: age, sex, race, children, study start date and final date.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Why it stopped: Not enough participants were recruited for a quality study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omphis Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat de Lleida
- Responsible party
- Principal investigator, Juan Vicente, López Díaz, Omphis Foundation
- Investigators
- Carmen Campoy, PHD, Principal investigator, Universitat se LleidaJuan Vicente López Díaz, PHD, Study director, Universitat de Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939416
- Sponsor's protocol ID
- Pold-fibromyalgia-udl
- Status last verified
- Jun 2025
- First submitted
- 2 May 2019
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Influence of Manual Therapy According to the POLD Method Within a Pain Treatment Program in Fibromyalgia
- ClinicalTrials.gov ID
- NCT03939416
- Acronym / sponsor ID
- Pold-fibromyalgia-udl
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Chronic pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants were recruited for a quality study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Omphis FoundationUniversity, hospital or other
- Collaborators
- Universitat de Lleida
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 6 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POLD concept treatment | Experimental | Other: ExperimentalPatients treated with rhythmic mobilizations according to the POLD concept, in addition to the standart treatment |
| CONTROL | Active comparator | Other: ControlPatients treated with the standart treatment |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: POLD concept treatment + standart treatmentSTANDART 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 | POLD concept treatment |
| ControlAlso: Standart treatmentSTANDART 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 | CONTROL |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Campoy, PHD principal investigator
Universitat se Lleida
Juan Vicente López Díaz, PHD study director
Universitat de Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Fibromyalgia, run by Omphis Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: Participants will be followed for the duration of treatment application, an expected average of 8 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.