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

Official title

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.

Overview

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.

Interventions

• Other education about pain and physical excersice
  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 exercis
• Other education about pain and physical excersice with somatosensorial treatment
  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 performe
• Other Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy
  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 Rehabilita

Primary outcome measures

• Change from Baseline in the value of quality of life measured Trough sf 36 questionnaire at 6 Months [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]

Secondary outcome measures (12)

• Change from Baseline in the value of pain intensitivity measured trough AVS scale at 6 Months [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of Conditional pain modulation system at 6 Months trough Protocol validated by Larsen et al. [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of lumbar disability index measured Trough Rolland Morris Scale at 6 Months [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of Level of severity of the case at 6 Months trough the Central Sensitization Inventory [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of sleep quality and patterns in adults of the case at 6 Months trough The Pittsburgh Sleep Quality Questionnaire (PSQI) [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of Medication intake of the case at 6 Months trough a survey [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• During the follow-up period, visits to the family doctor, emergency services, and specialists will be recorded using the Digital Health Record. [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]
• Change from Baseline in the value of satisfaction with health services of the case at 6 Months trough The Spanish version of the Client Satisfaction Questionnaire (CSQ-8) [Time frame: from the start of treatment, at 11 weeks and at 26 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT07133607 · FISIOTERAPIA3 · AP-AADC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗