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

Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain: a Multicenter Randomized Controlled Trial.

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. This approach involves no medications or invasive procedures and is based on pain neuroscience education and physical exercise, either alone or combined with treatment targeting body schema and somatosensory disturbances. The comparison will be made against a treatment involving thermotherapy and traditional physical exercise.

One of the most well-documented national primary care experiences combining pain neuroeducation and physical exercise, with a detailed methodology, was carried out by the Health System of Castilla y León (Sacyl) in Valladolid. It yielded significant results using a protocol consisting of 6 sessions of pain neuroscience education and 18 sessions of group exercise.

Based on this reference study, two hypotheses are proposed: the first is that reducing the number of sessions in the Active Coping Protocol for Chronic Pain would maintain treatment effectiveness. The second hypothesis suggests the potential for improved outcomes by combining the Active Coping Protocol with body schema and somatosensory disturbance treatment.

To test these hypotheses, a randomized experimental study with three parallel groups will be conducted on patients aged 18 to 70, referred to Physiotherapy from health centers in the Sevilla Health District. These patients experience daily spinal chronic pain for more than 3 months or on at least half of the days over more than 6 months, with central sensitization as the underlying cause.

Effectiveness will be measured in terms of quality of life (SF-36), pain intensity (Visual Analog Scale), satisfaction level, kinesiophobia, catastrophizing, pressure pain threshold, disability index (NDI/Oswestry), medication reduction, and number of monthly medical appointments.

Secondary objectives include evaluating, in both experimental groups compared to the control, the outcome variables: pain intensity, treatment adherence, kinesiophobia, catastrophizing, pressure pain threshold, descending modulation system, lumbar disability index, severity level, anxiety, sleep quality, analgesic consumption, healthcare visits, and satisfaction with care received.

A sample size of 135 patients has been calculated and will be randomized into the three study groups. The control group will receive thermotherapy-electrotherapy and conventional therapeutic exercise. Experimental group 1 will follow the Active Coping Program for Chronic Pain (4 education sessions and 12 physical exercise sessions). Experimental group 2 will receive somatosensory and body schema treatment along with the Active Coping Program.

The study is evaluator-blinded. Statistical analysis will be performed using SPSS version 28 and R Core Team (2023). Statistical significance will be set at p-values <0.05. Authorization will be requested from the relevant Research Ethics Committee.

The results of this study may lead to updates of existing protocols, development of guidelines and manuals for managing chronic musculoskeletal pain, ongoing training for primary care professionals, and publication in high-impact scientific journals to disseminate knowledge.

Inclusion Criteria:

• 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 Criteria:

• 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.