Chronic Musculoskeletal PainNCT03100721
Pain Neuroscience Education in Chronic Musculoskeletal Pain
A study testing PNE+Physiotherapy and Physiotherapy in people with Chronic Musculoskeletal Pain, run by University of Malaga at 1 site in Spain.
Trial summary
Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks by changing the mood and concentration of this population that suffers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- PNE+Physiotherapy and Physiotherapy
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2018to 22 Jan 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years
- Chronic Musculoskeletal Pain according to the ACCTION-APS Pain Taxonomy (AAPT), included chronic axial musculoskeletal low back pain
Who cannot join
- Chronic postoperative musculoskeletal pain and chronic musculoskeletal pain related to a traumatic injury six months before the beginning of the trial
- Inability to provide written informed consent and/or complete questionnaires in Spanish.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education as a Complement to Physiotherapy in Patients With Chronic Musculoskeletal Pain: a Non-randomized Controlled Trial
Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks by changing the mood and concentration of this population that suffers.
In a study carried out in 2010, 17% of the Spanish population had experienced pain in the last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24% mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck pain and 23% due to shoulder pain.
Pain neuroscience education (PNE) has been shown as an effective treatment strategy in increasing knowledge and understanding of neurobiology, neurophysiology and pain processing, modifying beliefs about it, improving patient skills and encouraging to the accomplishment of physical and social activities in different chronic pathologies.
Read the detailed description
Study design and setting: The design of the present study will be a quasi-experimental study with 2 follow-ups (one month and four months after intervention) that will be performed between Apr 2018 and Apr 2020 in public health system in Malaga, Spain. The outcomes will be assessed at baseline (t0), one month (t1) and four months after the physiotherapy treatment begins (t2). Written informed consent will be acquired for all participants prior to their participation.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- PNE+Physiotherapy, Physiotherapy
- Keywords
- Education, Chronic pain, Musculoskeletal pain, Self-efficacy
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNE+PhysiotherapyBehavioural
Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
PhysiotherapyProcedure or surgery
Physiotherapy cover kinesitherapy and exercises techniques.
| Study group | Role | What they receive |
|---|---|---|
| PNE+Physiotherapy | Experimental | Pain neuroscience education (PNE) 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 one time (at baseline). Physiotherapy includes kinesitherapy and exercises. Receives: Behavioral: PNE+Physiotherapy |
| Physiotherapy | Active comparator | Physiotherapy includes kinesitherapy and exercises. Receives: Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline self-efficacy at 1 and 4 months
This outcome will be measured with the Chronic Pain Self-Efficacy Scale
Measured: 1 and 4 months
Secondary outcomes (2)
Change from Baseline pain and pain interference at 1 and 4 months
This outcome will be measured with the Graded Chronic Pain Scale
Measured: 1 and 4 months
Change from Baseline analgesic medication at 1 and 4 months
This outcome will be measured checking digital medical history
Measured: 1 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start4 Apr 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza Progreso y Salud
- 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
- NCT03100721
- Sponsor's protocol ID
- PNE in MSK
- Status last verified
- Jun 2020
- First submitted
- 22 Mar 2017
- Last updated
- 4 Jun 2020
- 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 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education as a Complement to Physiotherapy in Patients With Chronic Musculoskeletal Pain: a Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03100721
- Acronym / sponsor ID
- PNE in MSK
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Education, Chronic pain, Musculoskeletal pain, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza Progreso y Salud
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 4 Apr 2017 (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.
Chronic musculoskeletal pain (CMP) is highly prevalent, disabling and with high socio-economic costs, with many negative effects on quality of life. CMP affects the ability to perform work, social, recreational and domestic tasks by changing the mood and concentration of this population that suffers.
In a study carried out in 2010, 17% of the Spanish population had experienced pain in the last month and according to the severity of symptoms 12% felt severe , 64% moderate and 24% mild pain. In this same study it is specified that 61% was due to back pain, 29% due to neck pain and 23% due to shoulder pain.
Pain neuroscience education (PNE) has been shown as an effective treatment strategy in increasing knowledge and understanding of neurobiology, neurophysiology and pain processing, modifying beliefs about it, improving patient skills and encouraging to the accomplishment of physical and social activities in different chronic pathologies.
Detailed description
Study design and setting: The design of the present study will be a quasi-experimental study with 2 follow-ups (one month and four months after intervention) that will be performed between Apr 2018 and Apr 2020 in public health system in Malaga, Spain. The outcomes will be assessed at baseline (t0), one month (t1) and four months after the physiotherapy treatment begins (t2). Written informed consent will be acquired for all participants prior to their participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNE+Physiotherapy | Experimental | Behavioral: PNE+PhysiotherapyPain neuroscience education (PNE) 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 one time (at baseline). Physiotherapy includes kinesitherapy and exercises. |
| Physiotherapy | Active comparator | Procedure: PhysiotherapyPhysiotherapy includes kinesitherapy and exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-65 years
- Chronic Musculoskeletal Pain according to the ACCTION-APS Pain Taxonomy (AAPT), included chronic axial musculoskeletal low back pain
Key exclusion criteria (2 listed)
- Chronic postoperative musculoskeletal pain and chronic musculoskeletal pain related to a traumatic injury six months before the beginning of the trial
- Inability to provide written informed consent and/or complete questionnaires in Spanish.
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 |
|---|---|---|
| PNE+PhysiotherapyPhysiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed. | Behavioural | PNE+Physiotherapy |
| PhysiotherapyPhysiotherapy cover kinesitherapy and exercises techniques. | Procedure or surgery | Physiotherapy |
Primary outcome
Change from Baseline self-efficacy at 1 and 4 months
Time frame: 1 and 4 months
This outcome will be measured with the Chronic Pain Self-Efficacy Scale
2 secondary outcomes
Change from Baseline pain and pain interference at 1 and 4 months
Time frame: 1 and 4 months
Change from Baseline analgesic medication at 1 and 4 months
Time frame: 1 and 4 months
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 4 Jun 2020.
- 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 principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNE+Physiotherapy and Physiotherapy in people with Chronic Musculoskeletal Pain, run by University of Malaga 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 2 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: finished, as of the sponsor's last update on 4 Jun 2020. 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?
Change from Baseline self-efficacy at 1 and 4 months (time frame: 1 and 4 months). 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 4 Jun 2020.