3h of PNE on BDNF and Pain Levels

Not Applicable

Recruiting

• Conditions: Chronic Pain; Musculoskeletal Pain
• Interventions: Behavioral: Pain neuroscience grupal education

• Registration Number: NCT05736172
• Lead Sponsor: Universidad Autonoma de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Study Start: 2023-05-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-05-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain group education	Pain neuroscience grupal education	In this group, the education session will be provided in a face-to-face group setting.
Pain material education	Pain neuroscience grupal education	In this group the same education session will be provided in written form by means of a leaflet.

Primary Outcome Measures

Name	Time	Method
BDNF level	three hours	BDNF level measured in blood serum by ELISA kit at baseline and at the end of the intervention.
Pain Intensity	three hours	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

Name	Time	Method
Pain Catastrophism Scale (PCS)	3 hours	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)	3 hours	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
Anxiety and Depression (HADS)	3 hours	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)	3 hours	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.

Trial Locations

Locations (1)

Silvia Di Bonaventura; 🇪🇸 Madrid, Spain