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Chronic PainNCT05623579

Education on BDNF on Pain Levels

A study testing Pain Neuroscience Education and Exercise in people with Chronic Pain and Musculoskeletal Pain, run by Universidad Autonoma de Madrid at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Pain, Musculoskeletal Pain
What is being tested?
Pain Neuroscience Education and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesSpain
Study dates
1 Oct 2023to 28 May 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • males and females aged 18 to 65 years with musculoskeletal pain for a minimum of 3 months
  • patients recruited by information pamphlets from the university clinic of the Rey Juan Carlos University, and CSEU La Salle
  • not having received physiotherapy treatment for this same process in the last 3 months.
  • ability to perform all the clinical tests and to understand the study process, as well as to obtain informed consent.

Who cannot join

  • Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites, 2 recruiting

  • Clínica URJC

    Alcorcón, Madrid, 28922

    Josue Fernández-Carnero, josue.fernadez@urjc.es

    Not yet recruiting

  • IRF La Salle

    Madrid, 28023

    Luis Matesanz, +34607712148, luis.matesanz@lasallecanpus.es

    Silvia Di Bonaventura

    Recruiting

Other trials in Spain

About this study

Official title: Effect of Therapeutic Education on Pain Intensity and BDNF Levels in Patients With Chronic Pain

The promotion of neuroplasticity in conjunction with strategies for restructuring maladaptive cognitions that largely cause the activation of neural networks that contribute to the perpetuation of pain is therefore a fundamental neurophysiological principle for establishing a neurophysiological basis for pain.

perpetuation of pain, is therefore a fundamental neurophysiological principle for establishing physiotherapy therapeutic to establish therapeutic strategies from physiotherapy that contribute to improve the quality of life of patients with chronic pain. patients with chronic pain.

Read more

Based on the theory that neurotrophic factors such as BDNF play a fundamental role in the initiation and or maintenance of hyperexcitability of central neurons in pain, we consider that the levels of this neurotrophic factor, such as BDNF, may have an important role in the perpetuation of pain.

that the levels of this neurotrophic factor may be modified by the application of a therapeutic education protocol, favoring therapeutic education protocol, favoring a reduction in pain intensity.

Being tested
Pain Neuroscience Education, Exercise
Keywords
BDNF, Pain Neuroscience Education, Exercise
Medical subject headings
Chronic Pain, Musculoskeletal Pain, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Neuroscience EducationBehavioural

    8 Sessions of different pain education interventions

  • ExerciseBehavioural

    12 Sessions of Aerobic Exercise

Study groups in NCT05623579
Study groupRoleWhat they receive
InterventionExperimentalPain Education plus Exercise
Receives: Behavioral: Pain Neuroscience Education; Behavioral: Exercise
ControlActive comparatorExercise
Receives: Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity

    Pain intensity assessed with the 100 mm Visual Analog Scale, in which the patient is asked about his or her pain level at that moment, with one side being "no pain" and the other extreme being "the worst pain imaginable".

    Measured: 36 weeks

Secondary outcomes (7)

  1. BDNF level

    BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.

    Measured: 36 weeks

  2. Anxiety and Depression (HADS)

    Anxiety and depression will be assessed using the Spanish validated version of the HADS. The HADS is a self-administered measure with 14 items in total that ask the client to reflect on their mood in the past week. Seven items assess depression, 5 of which are markers for anhedonia (an inability to experience pleasure), and 2 concern appearance and feelings of slowing down. Seven items assess anxiety, of which 2 assess autonomic anxiety (panic and butterflies in the stomach), and the remaining 5 assess tension and restlessness (Dunbar, Ford, Hunt, \& Der, 2000).

    Measured: 36 weeks

  3. Quality of life (EQ-5D)

    The EQ-5D is a generic HRQoL. HRQoL that can be used both in relatively healthy individuals (general population) and in groups of patients with different pathologies. The individual assesses his or her own health status, first in levels of severity by dimensions and then on a more general visual analog scale (VAS).The third element of the EQ-5D is the index of social values that is obtained for each health state generated by the instrument. In this part of the questionnaire, the individual must mark the level of severity corresponding to his or her health status in each of the dimensions health status in each of the dimensions, referring to the same day on which the same day the questionnaire is completed.

    Measured: 36 weeks

  4. Pain Catastrophism (PCS)

    Pain Catastrophism will be measured with the Spanish version of the Pain Catastrophism Scale. The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire considered to be the most frequent and extensively studied tool to assess pain catastrophizing for chronic pain. Good levels of content and construct validity, internal consistency and test-retest reliability of the PCS have been reported in studies examining different musculoskeletal disorders and different language versions.

    Measured: 36 weeks

  5. Pain Severity Level (GCPS-R)

    Pain severity will be measured Chronic Pain Grading Scale Description: A measure of pain intensity and interference with normal daily activities.

    Format: 7 items

    Scoring: Scores for 6 of the items range from 0 (no pain) to 10 (pain as bad as it could be). The one remaining item requires filling in the number of days that pain has kept respondents from their typical activities.

    Scores classify respondents into one of 4 levels of pain intensity and activity interference:

    Low disability and low pain intensity Low disability and high pain intensity High disability and moderate limitation of activities High disability and severe limitation of activities

    Measured: 36 weeks

  6. Oxygen Saturation (SpO2)

    measured with a finger pulse oximeter: A normal ABG oxygen level for healthy lungs falls between 80 and 100 millimeters of mercury (mm Hg).

    Measured: 36 weeks

  7. Heart rate (HR)

    measured with a finger pulse oximeter: A normal Heart Rate is between 60 and 120 pulse per minute.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start1 Oct 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion28 May 2025 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623579
Sponsor's protocol ID
2022A36005
Status last verified
Nov 2023
First submitted
25 Oct 2022
Last updated
30 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth. 2019 Aug;123(2):e273-e283. doi: 10.1016/j.bja.2019.03.023. Epub 2019 May 10.

    PubMed 31079836

  • Andias R, Neto M, Silva AG. The effects of pain neuroscience education and exercise on pain, muscle endurance, catastrophizing and anxiety in adolescents with chronic idiopathic neck pain: a school-based pilot, randomized and controlled study. Physiother Theory Pract. 2018 Sep;34(9):682-691. doi: 10.1080/09593985.2018.1423590. Epub 2018 Jan 10.

    PubMed 29319386

Questions about this trial

What is this clinical trial studying?

A study testing Pain Neuroscience Education and Exercise in people with Chronic Pain and Musculoskeletal Pain, run by Universidad Autonoma de Madrid at 2 sites 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 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623579, which also lists 2 linked publications.

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 30 Nov 2023.

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