Status:

NOT_YET_RECRUITING

Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain

Lead Sponsor:

Distrito de Atención Primaria Sevilla

Collaborating Sponsors:

Junta de Andalucia

Conditions:

Chronic Pain (Back / Neck)

Eligibility:

All Genders

18-70 years

Phase:

NA

Brief Summary

The main objective of the project is to evaluate the effectiveness, in terms of quality of life, of a therapy based on an Active Coping Protocol for Non-Cancer Chronic Pain in the Primary Care setting...

Eligibility Criteria

Inclusion

  • Users of the Public Health System of Andalusia, registered in the User Database (BDU) of the Sevilla Health District.
  • Ages between 18 and 70.
  • Chronic lumbar pain lasting more than 3 months, likely due to central sensitization (likely nociplastic pain).
  • The diagnosis of Central Sensitization will be made according to the most recent algorithm published by Nijs et al. in Lancet.

Exclusion

  • Oncological pain (pain related to cancer)
  • Spinal fracture or spinal surgery in the previous year.
  • Neurological cognitive impairment that prevents understanding of pain neuroeducation (if in doubt, the Minimental Test will be performed, requiring a minimum score of 25)
  • Physical conditioning deficit that prevents the execution of the Physical --Education program (minimum requirement: normal execution time of \<10 seconds for the timed "Up and Go" test).
  • Pregnancy
  • Cauda equina syndrome
  • Chronic fatigue syndrome
  • Fibromyalgia
  • Complex Regional Pain Syndrome
  • Clinical conditions that may aggravate chronic spinal pain.
  • Associated pathologies that prevent the performance of a physical exercise program (myopathies and neurological disorders).
  • Currently undergoing alternative therapies.
  • The presence of pain in other anatomical regions, apart from spinal pain, is not a reason for exclusion.

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

135 Patients enrolled

Trial Details

Trial ID

NCT07133607

Start Date

September 1 2025

End Date

December 31 2026

Last Update

September 11 2025

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