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Education on BDNF on Pain Levels

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain Neuroscience Education
Exercise
Sponsored by
Universidad Autonoma de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring BDNF, Pain Neuroscience Education, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: - Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.

Sites / Locations

  • Clínica URJC
  • IRF La Salle

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Pain Education plus Exercise

Exercise

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

BDNF level
BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.
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).
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.
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.
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
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).
Heart rate (HR)
measured with a finger pulse oximeter: A normal Heart Rate is between 60 and 120 pulse per minute.

Full Information

First Posted
October 25, 2022
Last Updated
July 13, 2023
Sponsor
Universidad Autonoma de Madrid
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05623579
Brief Title
Education on BDNF on Pain Levels
Official Title
Effect of Therapeutic Education on Pain Intensity and BDNF Levels in Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
September 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
BDNF, Pain Neuroscience Education, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pain Education plus Exercise
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Exercise
Intervention Type
Behavioral
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
8 Sessions of different pain education interventions
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
12 Sessions of Aerobic Exercise
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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".
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
BDNF level
Description
BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.
Time Frame
36 weeks
Title
Anxiety and Depression (HADS)
Description
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).
Time Frame
36 weeks
Title
Quality of life (EQ-5D)
Description
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.
Time Frame
36 weeks
Title
Pain Catastrophism (PCS)
Description
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.
Time Frame
36 weeks
Title
Pain Severity Level (GCPS-R)
Description
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
Time Frame
36 weeks
Title
Oxygen Saturation (SpO2)
Description
measured with a finger pulse oximeter: A normal ABG oxygen level for healthy lungs falls between 80 and 100 millimeters of mercury (mm Hg).
Time Frame
36 weeks
Title
Heart rate (HR)
Description
measured with a finger pulse oximeter: A normal Heart Rate is between 60 and 120 pulse per minute.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: - Systemic, neurological, oncological or inflammatory diseases; psychiatric pathologies, pregnancy, type II diabetes.
Facility Information:
Facility Name
Clínica URJC
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josue Fernández-Carnero
Email
josue.fernadez@urjc.es
Facility Name
IRF La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Matesanz
Email
luis.matesanz@lasallecanpus.es
First Name & Middle Initial & Last Name & Degree
Silvia Di Bonaventura

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31079836
Citation
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.
Results Reference
background
PubMed Identifier
29319386
Citation
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.
Results Reference
result

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Education on BDNF on Pain Levels

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