FibromyalgiaNCT03641495
Pain Education and Therapeutic Exercise for Fibromyalgia
A study testing PE+ET and ET in people with Fibromyalgia, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- PE+ET and ET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 3 Sep 2018to 30 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed medically with Fibromyalgia
- Diagnosed according to the American College of Rheumatology criteria
- Agreement to attend to treatment sessions
Who cannot join
- Any kind of contraindications for physical activity
- Other kind of diseases that could limit the intervention
- Previous surgery last year
- Medication modifications in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.
The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.
Read more
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.
- Conditions
- Fibromyalgia
- Being tested
- PE+ET, ET
- Keywords
- fibromyalgia, therapeutic exercise, physiotherapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PE+ETOther
To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
ETOther
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Pain education plus exercise therapy (PE + ET) | Experimental | Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations. Receives: Other: PE+ET |
| Exercise therapy (ET) | Active comparator | Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations. Receives: Other: ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity: VAS
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
Measured: Baseline
Pain Intensity: VAS
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Measured: through study completion, an average 10 weeks
Fibromyalgia Impact Questionnaire
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
Measured: Baseline
Fibromyalgia Impact Questionnaire
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
Measured: through study completion, an average 10 weeks
Secondary outcomes (18)
Fatigue
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline
Measured: Baseline
Fatigue
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
Measured: through study completion, an average 10 weeks
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Measured: Baseline
Quality of Sleep: Pittsburg Sleeping Questionnaire
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
Measured: through study completion, an average 10 weeks
Functional Capacity
The investigators measure the functional capacity with Senior Fitness Test at baseline
Measured: Baseline
Functional Capacity
The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
Measured: through study completion, an average 10 weeks
body strength
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline
Measured: baseline
body strength
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment
Measured: through study completion, an average 10 weeks
Pressure pain threshold
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at baseline
Measured: baseline
Pressure pain threshold
The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
Measured: through study completion, an average 10 weeks
Anxiety and Depression
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline
Measured: Baseline
Anxiety and Depression
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
Measured: through study completion, an average 10 weeks
kinesiophobia
The investigators measure the kinesiophobia with TAMPA questionnaire at baseline
Measured: baseline
kinesiophobia
The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment
Measured: through study completion, an average 10 weeks
Quality of life: HAQ
The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline
Measured: baseline
Quality of life: HAQ
The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment
Measured: through study completion, an average 10 weeks
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
Measured: baseline
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment
Measured: through study completion, an average 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start3 Sep 2018
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
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
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valladolid
- Responsible party
- Principal investigator, Sandra Jiménez, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641495
- Sponsor's protocol ID
- University of Valladolid
- Status last verified
- Mar 2021
- First submitted
- 16 Aug 2018
- Last updated
- 26 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The patient data were confidential and were assigned a number to each patient to maintain confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03641495
- Acronym / sponsor ID
- University of Valladolid
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, therapeutic exercise, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- University of Valladolid
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 22 Aug 2018 (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.
Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.
The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.
For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).
Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.
The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain education plus exercise therapy (PE + ET) | Experimental | Other: PE+ETPain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations. |
| Exercise therapy (ET) | Active comparator | Other: ETExercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed medically with Fibromyalgia
- Diagnosed according to the American College of Rheumatology criteria
- Agreement to attend to treatment sessions
Key exclusion criteria (4 listed)
- Any kind of contraindications for physical activity
- Other kind of diseases that could limit the intervention
- Previous surgery last year
- Medication modifications in the last 3 months
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 |
|---|---|---|
| PE+ETTo explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain. To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate. | Other | Pain education plus exercise therapy (PE + ET) |
| ETTo perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate. | Other | Exercise therapy (ET) |
Primary outcome
Pain Intensity: VAS
Time frame: Baseline
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
Pain Intensity: VAS
Time frame: through study completion, an average 10 weeks
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Fibromyalgia Impact Questionnaire
Time frame: Baseline
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
Fibromyalgia Impact Questionnaire
Time frame: through study completion, an average 10 weeks
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
18 secondary outcomes
Fatigue
Time frame: Baseline
Fatigue
Time frame: through study completion, an average 10 weeks
Quality of Sleep
Time frame: Baseline
Quality of Sleep: Pittsburg Sleeping Questionnaire
Time frame: through study completion, an average 10 weeks
Functional Capacity
Time frame: Baseline
Functional Capacity
Time frame: through study completion, an average 10 weeks
body strength
Time frame: baseline
body strength
Time frame: through study completion, an average 10 weeks
Pressure pain threshold
Time frame: baseline
Pressure pain threshold
Time frame: through study completion, an average 10 weeks
Anxiety and Depression
Time frame: Baseline
Anxiety and Depression
Time frame: through study completion, an average 10 weeks
kinesiophobia
Time frame: baseline
kinesiophobia
Time frame: through study completion, an average 10 weeks
Quality of life: HAQ
Time frame: baseline
Quality of life: HAQ
Time frame: through study completion, an average 10 weeks
Central sensitization
Time frame: baseline
Central sensitization
Time frame: through study completion, an average 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: No. The patient data were confidential and were assigned a number to each patient to maintain confidentiality
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE+ET and ET in people with Fibromyalgia, run by Universidad de Zaragoza 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 26 Mar 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Intensity: VAS (time frame: Baseline). 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 26 Mar 2021.