Active Coping: Interdisciplinary Program for Chronic Pain, Physiotherapy Unit (Spain)

Interdisciplinary Active Coping Program for Chronic Pain in the Physiotherapy Unit in Primary Care - Teruel Health Sector (Aragón, Spain)

The goal of this observational intervention study is to evaluate the impact of a multidisciplinary active coping program for chronic back pain in adults referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche. The main questions it aims to answer are:

• Does the program improve physical function, measured through gait speed, balance, and chair stand tests?
• Does it reduce pain-related psychological factors such as kinesiophobia, catastrophizing, anxiety, and depression?
• Does it improve quality of life and sleep quality, and reduce analgesic medication use?

Participants will attend group sessions on pain neuroscience education, followed by sessions on healthy habits, nutrition and sleep hygiene and group psychological intervention focused on emotional wellbeing tools, and will complete therapeutic exercise sessions over the course of the program. They will also complete validated questionnaires and physical assessments at three timepoints: at baseline, at the end of the program, and at a 6-month follow-up.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain; Musculoskeletal Pain; Chronic Pain; Kinesiophobia; Chronic Back Pain; Low Back Pain, Chronic
• Intervention / Treatment: Behavioral: Pain Neuroscience Education (PNE); Behavioral: Healthy Habits and Psychological Intervention; Behavioral: Therapeutic Exercise

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mª Teresa Muñoz Tomás, Fisioterapeuta; Phone Number: +34 722537086; Email: mtmunnozto@salud.aragon.es
• Study Contact Backup: Name: GAIAP; Phone Number: +34 622 71 97 59; Email: gaiap.contacto@gmail.com

Study Locations

• Spain
  • Aragon
    • Teruel, Aragon, Spain, 44001
      • CS Teruel Centro
      • Contact: Mónica Lasheras Barrio, Médico de Familia; Phone Number: +34 626074663; Email: mlasherasb@salud.aragon.es
      • Principal Investigator: Mónica Lasheras Barrio, Médica de Familia
      • Sub-Investigator: Ainara Alonso Valbuena, Médica de Familia
    • Teruel, Aragon, Spain, 44002
      • Centro de Salud Teruel Ensanche
      • Contact: Mª Teresa Muñoz Tomás; Phone Number: +34 722537086; Email: mlasherasb@salud.aragon.es
      • Principal Investigator: Mª Teresa Muñoz Tomás, Fisioterapeuta
      • Sub-Investigator: Mª Jesús Villa Oro, Fisioterapia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult (18 years or older)
• Diagnosis of non-oncological chronic back pain
• Referred from Primary Care to the Physiotherapy Unit of Teruel Ensanche . (UFAP) from one of the following basic health zones: Teruel Centro, Teruel Ensanche, Albarracín, Alfambra, Cella, or Villel
• Able to provide voluntary written informed consent

Exclusion Criteria:

• Oncological pain
• Cognitive impairment that prevents following the program
• Spinal surgery in the last year
• Internal electrostimulator device (e.g. pacemaker, spinal cord stimulator)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multidisciplinary Active Coping Program; All participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.

Behavioral: Pain Neuroscience Education (PNE); Group sessions led by primary care physicians aimed at shifting participants' understanding of chronic pain mechanisms, reducing unhelpful beliefs about pain and movement, and promoting active coping strategies. Knowledge is assessed before and after sessions using a validated survey. Timing: March 2026; Behavioral: Healthy Habits and Psychological Intervention; Group sessions addressing nutrition and sleep hygiene, combined with group and individual psychological sessions focused on emotional wellbeing and coping tools for chronic pain management. Timing: April 2026; Behavioral: Therapeutic Exercise; Timing: May-June 2026 Description: Progressive group therapeutic exercise sessions led by physiotherapists, targeting physical function, balance, gait speed, and strength in participants with chronic back pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Health-Related Quality of Life as Measured by the SF-36 v2 at End of Program and 6-Month Follow-Up	The SF-36 measures health-related quality of life across 8 dimensions: physical function, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100, where 0 indicates the worst possible health state and 100 indicates the best possible health state.	Baseline, end of program, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Functional Disability as Measured by the Roland-Morris Disability Questionnaire at End of Program and 6-Month Follow-Up	The Roland-Morris Disability Questionnaire assesses the degree of functional disability caused by back pain in daily life. Scores range from 0 to 24, where 0 indicates no disability and 24 indicates the maximum level of disability.	Baseline, end of program, 6-month follow-up
Change from Baseline in Physical Performance as Measured by the Short Physical Performance Battery (SPPB) at End of Program and 6-Month Follow-Up	The SPPB evaluates three aspects of physical mobility: balance, gait speed, and lower limb strength (chair stand test). Total scores range from 0 to 12, where 0 indicates the worst physical performance and 12 indicates the best physical performance.	Baseline, end of program, 6-month follow-up
Change from Baseline in Dynamic Balance as Measured by the Timed Up and Go Test (TUG) at End of Program and 6-Month Follow-Up	The TUG measures the time in seconds required to stand up from a chair, walk 3 metres, return, and sit down. Scores above 13.5 seconds indicate risk of falls; below 10 seconds indicates unrestricted mobility.	Baseline, end of program, 6-month follow-up
Change from Baseline in Lower Limb Strength and Balance as Measured by the 30-Second Sit-to-Stand Test at End of Program and 6-Month Follow-Up	The 30-second sit-to-stand test records the number of times a participant can stand from a chair without using their arms in 30 seconds. Fewer than 8 repetitions indicates fall risk. Higher scores indicate better lower limb strength and balance.	Baseline, end of program, 6-month follow-up
Change from Baseline in Gait Speed and Exercise Tolerance as Measured by the 6-Minute Walk Test at End of Program and 6-Month Follow-Up	The 6-Minute Walk Test records the total distance in metres walked in 6 minutes, with perceived exertion assessed using the Modified Borg Scale ranging from 0 (no exertion at all) to 10 (maximum exertion). Greater distance indicates better exercise tolerance.	Baseline, end of program, 6-month follow-up
Change from Baseline in Kinesiophobia as Measured by the Tampa Scale for Kinesiophobia (TSK-11SV) at End of Program and 6-Month Follow-Up	The TSK-11SV assesses fear of movement and re-injury in people with chronic pain. Scores range from 11 to 44, where higher scores indicate greater kinesiophobia	Baseline, end of program, 6-month follow-up
Change from Baseline in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (ECD) at End of Program and 6-Month Follow-Up	The ECD assesses the tendency to magnify, ruminate, and feel helpless in response to pain across 13 items. Scores range from 0 to 52, where higher scores indicate greater pain catastrophizing.	Baseline, end of program, 6-month follow-up
Change from Baseline in Central Sensitization Symptoms as Measured by the Central Sensitization Inventory (CSI) at End of Program and 6-Month Follow-Up	The CSI assesses the presence and intensity of somatic and emotional symptoms associated with Central Sensitization Syndrome across 25 items. Scores range from 0 to 100, where higher scores indicate greater central sensitization symptom burden.	Baseline, end of program, 6-month follow-up
Change from Baseline in Analgesic and Co-adjuvant Medication Use as Recorded by Medication Registry at End of Program and 6-Month Follow-Up	Medication use is recorded through a structured registry covering oral analgesics (paracetamol, minor and major opioids, antimigraine drugs), co-adjuvant drugs (corticosteroids, anticonvulsants, anxiolytics, antidepressants), and topical analgesics. Change is assessed as the presence, type, and dose per 24 hours of each medication category at each timepoint.	Baseline, end of program, 6-month follow-up
Change from Baseline in Frequency of Primary Care Consultations (Medical and Physiotherapy) at End of Program and 6-Month Follow-Up	Number of Primary Care consultations (both medical and physiotherapy) recorded per participant during the study period, extracted from clinical records. Higher consultation frequency indicates greater healthcare resource utilization.	Baseline, end of program, 6-month follow-up
Change from Baseline in Anxiety as Measured by the State-Trait Anxiety Inventory (STAI) at End of Program and 6-Month Follow-Up	The STAI assesses anxiety in two dimensions: state anxiety (momentary) and trait anxiety (stable predisposition), each scored across 20 items. Scores for each subscale range from 20 to 80, where higher scores indicate greater anxiety.	Baseline, end of program, 6-month follow-up
Change from Baseline in Depressive Symptoms as Measured by the Beck Depression Inventory II (BDI-II) at End of Program and 6-Month Follow-Up	The BDI-II evaluates the severity of depressive symptoms across 21 items covering cognitive, affective, and somatic domains. Scores range from 0 to 63, where 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression, and 29-63 severe depression.	Baseline, end of program, 6-month follow-up
Change from Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) at End of Program and 6-Month Follow-Up	The PSQI assesses subjective sleep quality and disturbances over the past month across 7 components including sleep latency, duration, efficiency, and daytime dysfunction. Global scores range from 0 to 21, where scores above 5 indicate poor sleep quality.	Baseline, end of program, 6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Neuroscience Knowledge as Measured by Pre/Post Survey Immediately Before and After Pain Neuroscience Education Sessions	A 10-item true/false/unsure survey assessing knowledge of chronic pain neuroscience concepts, including the relationship between pain and tissue damage, central sensitization, and active coping strategies. Higher correct response rates indicate greater pain neuroscience knowledge.	Immediately before and after PNE sessions (March 2026)

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza

Publications and helpful links

General Publications

• Geneen LJ, Moore RA, Clarke C, Martin D, Colvin LA, Smith BH. Physical activity and exercise for chronic pain in adults: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2017 Apr 24;4(4):CD011279. doi: 10.1002/14651858.CD011279.pub3.
• Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Apr 22;9(4):1201. doi: 10.3390/jcm9041201.
• Louw, A., & Riera-Gilley, V. (2024). Pain Neuroscience Education: Teaching People About Pain. Journal of Pain & Palliative Care Pharmacotherapy, 38(3), 292-301. https://doi.org/10.1080/15360288.2024.2424853

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Quality of Life; Anxiety; Primary Care; Physical Function; Psychological Intervention; Sleep Quality; Physiotherapy; Pain Catastrophizing; Pain Neuroscience Education; Therapeutic Exercise; Central Sensitization; Chronic Musculoskeletal Pain; Chronic Back Pain; Multidisciplinary Intervention; Active Coping; Primary Care Physiotherapy Unit
• Additional Relevant MeSH Terms: Organizing Pneumonia; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Mental Disorders; Immune System Diseases; Behavioral Symptoms; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Phobic Disorders; Graft vs Host Disease; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Bronchiolitis Obliterans Syndrome; Kinesiophobia; Back Pain; Anxiety Disorders; Musculoskeletal Pain; Chronic Pain; Depression; Sleep Initiation and Maintenance Disorders; Low Back Pain; Therapeutics; Physical Therapy Modalities; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Exercise Therapy; Psychosocial Intervention
• Other Study ID Numbers: C.I.PI26/047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

In accordance with the ethics committee approval (CEICA), individual participant data will not be shared with third parties. Data will be pseudonymized and stored locally with access restricted to the research team only, and will be destroyed in June 2027.

However, in the spirit of open science, the following supporting documents will be made publicly available upon publication of the main results

• IPD Sharing Time Frame: Supporting documents will be made available at the time of publication of the main results.

IPD Sharing Access Criteria

Who can access: Any researcher or member of the public interested in the study methodology and materials.

What they can access: Study protocol, informed consent form, data collection instruments, and statistical analysis plan.

How they can access it: Supporting documents will be openly available through:

The Open Science Framework (OSF) The research group's institutional page PubMed via DOI upon publication of the main results

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No