FibromyalgiaNCT03044067
Effects of Pain Neuroscience Education in Fibromyalgia
A study testing Pain neuroscience education + Exercise and Exercise in people with Fibromyalgia, run by University of Malaga.
Trial summary
Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Pain neuroscience education + Exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Dec 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-70 years.
- Willing and able to participate
- Diagnosis of Fibromyalgia
Who cannot join
- Systemic diseases
- Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
Trial locations and contacts
No sites are listed yet.
Alejandro Luque Suarez, PhD contact
About this study
Official title: The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
Fibromyalgia is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.
Read the detailed description
Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
- Conditions
- Fibromyalgia
- Being tested
- Pain neuroscience education + Exercise, Exercise
- Keywords
- Chronic pain, Fibromyalgia, Pain neuroscience education, Exercise
- Medical subject headings
- Fibromyalgia, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education + ExerciseOther
A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
ExerciseOther
A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience education + Exercise | Experimental | Pain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Receives: Other: Pain neuroscience education + Exercise |
| Exercise | Active comparator | Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline function at 1 month
This outcome will be measured with the pain disability index (PDI)
Measured: 1 month
Change from Baseline pain at 1 month
This outcome will be measured with the numerical pain rating scale (NRS)
Measured: 1 month
Secondary outcomes (1)
Change from Baseline self-efficacy at 1 moths
Pain Self-Efficacy Questionnaire (PSEQ) contains 10 questions that will be measure the patient's confidence in performing certain activities despite pain.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startSep 2017 (estimated)
- Primary completionSep 2017 (estimated)
- Study completionDec 2017 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Luque-Suarez, University of Malaga
- Investigators
- Alejandro Luque Suarez, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044067
- Sponsor's protocol ID
- UniversityMalaga
- Status last verified
- Feb 2017
- First submitted
- 2 Feb 2017
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pain Neuroscience Education Plus Exercise in the Management of Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03044067
- Acronym / sponsor ID
- UniversityMalaga
- Conditions
- Fibromyalgia
- Keywords
- Chronic pain, Fibromyalgia, Pain neuroscience education, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Feb 2017 (estimated)
- 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 is one of the main causes of chronic musculoskeletal widespread pain. This condition presents a global prevalence of 2.7%, and it is more prevalent in women (with a female to male ratio of 3:1) over 50 years of age with low education level and low socioeconomic status, living in rural areas. High direct medical costs and significant indirect costs of this condition can't be ignored.
Detailed description
Study design and setting: The design of the present study will be a randomized controlled trial with 2 follow-ups (one week and one month after intervention) that will be performed between May 2017 and June 2017 in one private clinic in Malaga, Spain. The outcomes will be assessed at baseline (t1), one week after intervention (t2), and one moth after intervention (t3). Written informed consent will be acquired for all participants prior to their participation. The study will be implemented and reported in line with the CONSORT statement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience education + Exercise | Experimental | Other: Pain neuroscience education + ExercisePain neuroscience education can be defined as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. It will be applied three times (at baseline, one week and one month after intervention). Exercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. |
| Exercise | Active comparator | Other: ExerciseExercise will be based on a set of 4 exercise implicating flexion, extension, lateral rotation and abduction of lower and upper extremities. Participants will attend three appointments per week over three weeks. They will complete three sets of 10 repetitions, with the exercises progressed in difficulty at each appointment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18-70 years.
- Willing and able to participate
- Diagnosis of Fibromyalgia
Key exclusion criteria (2 listed)
- Systemic diseases
- Pain and function due to other rheumatic disorders such as: osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
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 |
|---|---|---|
| Pain neuroscience education + ExerciseA session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed. | Other | Pain neuroscience education + Exercise |
| ExerciseA session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. | Other | Exercise |
Primary outcome
Change from Baseline function at 1 month
Time frame: 1 month
This outcome will be measured with the pain disability index (PDI)
Change from Baseline pain at 1 month
Time frame: 1 month
This outcome will be measured with the numerical pain rating scale (NRS)
1 secondary outcome
Change from Baseline self-efficacy at 1 moths
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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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.
Alejandro Luque Suarez, PhD contact
Alejandro Luque Suarez, PhD principal investigator
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education + Exercise and Exercise in people with Fibromyalgia, run by University of Malaga.
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 2 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: status not confirmed, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Matias Soto, PT (616375349 ext. +34, msjavi93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline function at 1 month (time frame: 1 month). The study lists 2 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 3 May 2017.