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

NCT07504094 | Not Yet Recruiting

• 1 other identifier: C.I.PI26/047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Back Pain; Chronic Pain; Musculoskeletal Pain; Back Pain; Low Back Pain, Chronic; Kinesiophobia

Keywords

Pain Neuroscience Education; Therapeutic Exercise; Multidisciplinary Intervention; Active Coping; Psychological Intervention; Chronic Back Pain; Chronic Musculoskeletal Pain; Central Sensitization; Pain Catastrophizing; Primary Care; Physiotherapy; Primary Care Physiotherapy Unit; Quality of Life; Physical Function; Sleep Quality; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change from Baseline in Functional Disability as Measured by the Roland-Morris Disability Questionnaire at End of Program and 6-Month Follow-Up

  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

  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

  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

  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

  Baseline, end of program, 6-month follow-up

Other Outcomes (1)

• Change in Pain Neuroscience Knowledge as Measured by Pre/Post Survey Immediately Before and After Pain Neuroscience Education Sessions

  Immediately before and after PNE sessions (March 2026)

Study Arms (1)

Multidisciplinary Active Coping Program

EXPERIMENTAL

All participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.

Behavioral: Pain Neuroscience Education (PNE); Behavioral: Healthy Habits and Psychological Intervention; Behavioral: Therapeutic Exercise

Interventions

Pain Neuroscience Education (PNE) BEHAVIORAL

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

Multidisciplinary Active Coping Program

Healthy Habits and Psychological Intervention BEHAVIORAL

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

Multidisciplinary Active Coping Program

Therapeutic Exercise BEHAVIORAL

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.

Multidisciplinary Active Coping Program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (2)

CS Teruel Centro

Teruel, Aragon, 44001, Spain

Location

Centro de Salud Teruel Ensanche

Teruel, Aragon, 44002, Spain

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 28436583 BACKGROUND

• 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.

  PMID: 32331323 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Back Pain; Low Back Pain; Bronchiolitis Obliterans Syndrome; Musculoskeletal Pain; Kinesiophobia; Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Interventions

Psychosocial Intervention; Exercise Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Phobic Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Mª Teresa Muñoz Tomás, Fisioterapeuta

CONTACT

+34 722537086; mtmunnozto@salud.aragon.es

GAIAP

CONTACT

+34 622 71 97 59; gaiap.contacto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Research and Teaching Staff

Model Details: no control group, all participants receive the full intervention

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 31, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting documents will be made available at the time of publication of the main results.
• 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

Locations

ES (2)