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

NCT07133607 | Not Yet Recruiting

• 2 other identifiers: FISIOTERAPIA3AP-AADC
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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. 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.

Conditions

Chronic Pain (Back / Neck)

Keywords

pain chronic; central sensibilitation; public health system; pain education; physiotherapy; somatosensory; body outline; therapeutic physical exercise

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the value of quality of life measured Trough sf 36 questionnaire at 6 Months

  0 equals very poor quality of life and 100 very good quality of life

  from the start of treatment, at 11 weeks and at 26 weeks

Secondary Outcomes (16)

• Change from Baseline in the value of pain intensitivity measured trough AVS scale at 6 Months

  from the start of treatment, at 11 weeks and at 26 weeks

• Change from Baseline in the value of regular physical activity measured Trough international physical activity questionnaire (IPAQ)at 6 Months

  from the start of treatment, at 11 weeks and at 26 weeks

• Change from Baseline in the value of kinesophobia measured Trough kinesophobia questionnaireTampa-TSK-11SV at 6 Months

  from the start of treatment, at 11 weeks and at 26 weeks

• Change from Baseline in the value of Pain Catastrophizing measured Trough Pain Catastrophizing Scale (PCS) at 6 Months

  from the start of treatment, at 11 weeks and at 26 weeks

• Change from Baseline in the value of pain threshold to pressure at 6 Months trough the protocol described in the study by Neziri et al, measuring four points using the procedure described by Fisher

  from the start of treatment, at 11 weeks and at 26 weeks

Study Arms (3)

control group

ACTIVE COMPARATOR

The patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León (33), since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF) (34). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks.

Other: Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy

intervention type 1, education to pain and physical exercise

EXPERIMENTAL

The sessions will be conducted in groups of 10 to 15 patients. * 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks. * 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced. The session structure will be as recommended by the American College of Sports Medicine, with se

Other: education about pain and physical excersice

intervention type 2, education to pain and physical exercise with somatosensorial treatment

EXPERIMENTAL

Patients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2", somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior. The prescribed treatment will be repeated daily at home. To facilitate the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained. If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities. As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment.

Other: education about pain and physical excersice with somatosensorial treatment

Interventions

education about pain and physical excersice OTHER

The sessions will be conducted in groups of 10 to 15 patients. * 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks. * 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced. The session structure will be as recommended by the American College of Sports Medicine, with se

intervention type 1, education to pain and physical exercise

education about pain and physical excersice with somatosensorial treatment OTHER

Patients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2" (education about pain), somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior. The prescribed treatment will be repeated daily at home. To facilitate the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained. If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities. As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment.

intervention type 2, education to pain and physical exercise with somatosensorial treatment

Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy OTHER

The patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León, since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks.

control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Distrito de Atención Primaria Sevilla: lead
• Junta de Andalucia: collaborator

Related Publications (1)

• Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain neuroscience education and physical exercise for patients with chronic spinal pain in primary healthcare: a randomised trial protocol. BMC Musculoskelet Disord. 2019 Nov 3;20(1):505. doi: 10.1186/s12891-019-2889-1.

  PMID: 31679512 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise; Hyperthermia, Induced

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: parallel study for three interventions groups

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share