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3h of PNE on BDNF and Pain Levels (PNE/BDNF)

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain neuroscience grupal education
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

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 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

  • Silvia Di BonaventuraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain group education

Pain material education

Arm Description

In this group, the education session will be provided in a face-to-face group setting.

In this group the same education session will be provided in written form by means of a leaflet.

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

Secondary Outcome Measures

Anxiety and Depression (HADS)
Anxiety and depression will be assessed using the Spanish validated version of the HADS. The HADS is a selfadministered 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 EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix).7 8 A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.
Pain Catastrophism Scale (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. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11 Magnification: Sum of items 6, 7, 13 Helplessness: Sum of items 1, 2, 3, 4, 5, 12
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 p

Full Information

First Posted
February 9, 2023
Last Updated
May 5, 2023
Sponsor
Universidad Autonoma de Madrid
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT05736172
Brief Title
3h of PNE on BDNF and Pain Levels
Acronym
PNE/BDNF
Official Title
Effect of Therapeutic Education on Pain Levels and Brain Neurotrophic Factor in Patients With Chronic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (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
Data Monitoring Committee
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. 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

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
Pain group education
Arm Type
Experimental
Arm Description
In this group, the education session will be provided in a face-to-face group setting.
Arm Title
Pain material education
Arm Type
Active Comparator
Arm Description
In this group the same education session will be provided in written form by means of a leaflet.
Intervention Type
Behavioral
Intervention Name(s)
Pain neuroscience grupal education
Other Intervention Name(s)
Pain neuroscience written education
Intervention Description
The face to face education group will be carried out with a physiotherapist addressing various topics in the neurosciences of pain. In the active control group, information will only be provided in written form for the individual patient to read.
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
three hours
Title
BDNF level
Description
BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.
Time Frame
three hours
Secondary Outcome Measure Information:
Title
Anxiety and Depression (HADS)
Description
Anxiety and depression will be assessed using the Spanish validated version of the HADS. The HADS is a selfadministered 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
3 hours
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 EQ-5D comprises five questions on mobility, self care, pain, usual activities, and psychological status with three possible answers for each item (1=no problem, 2=moderate problem, 3=severe problem; see appendix).7 8 A summary index with a maximum score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems. In addition, there is a visual analogue scale (VAS) to indicate the general health status with 100 indicating the best health status.
Time Frame
3 hours
Title
Pain Catastrophism Scale (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. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11 Magnification: Sum of items 6, 7, 13 Helplessness: Sum of items 1, 2, 3, 4, 5, 12
Time Frame
3 hours
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 p
Time Frame
3 hours

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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Di Bonaventura
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silvia Di Bonaventura
City
Madrid
ZIP/Postal Code
28008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Di Bonaventura
Phone
655412476
Email
silvia.dibonaventura@urjc.es

12. IPD Sharing Statement

Plan to Share IPD
No

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3h of PNE on BDNF and Pain Levels

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