Physiotherapy Intervention Program for Chronic Pain Associated With Depressive Disorder

Effects of a Hybrid Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise in Individuals With Chronic Persistent Pain and Depressive Disorder: A Prospective Longitudinal Study

This prospective longitudinal pre-post intervention study aims to evaluate the effects of an 8-week physiotherapy program combining face-to-face and asynchronous tele-rehabilitation sessions in individuals with chronic persistent pain and depressive disorder. The intervention is based on pain neuroscience education and therapeutic exercise. Outcomes include pain intensity, psychosocial factors, adherence to treatment, usability of telemedicine, balance, body awareness, and participants' experiences collected through focus groups.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Chronic Pain; Persistent Pain
• Intervention / Treatment: Other: Hybrid Physiotherapy Program

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain
    • Zaragoza University and San Jorge University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 45-75 years
• User of AFDA and ASAPME
• Chronic persistent pain
• Written informed consent provided

Exclusion Criteria:

• Severe psychiatric disorders (including schizophrenia)
• Neurological diseases preventing participation
• No internet access
• Mini-Mental State Examination score ≤24
• Acute musculoskeletal disorders
• Rheumatic diseases
• Severe respiratory insufficiency
• Inability to understand Spanish
• Pregnancy, immunosuppression, transplantation or active oncological condition

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: Hybrid Physiotherapy Program; Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise

Other: Hybrid Physiotherapy Program; Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise: Behavioral: Pain Neuroscience Education Eight weekly face-to-face educational sessions complemented by asynchronous telematic educational videos covering pain neurophysiology, biopsychosocial approaches, neuroplasticity, motor imagery and self-management strategies. Behavioral: Therapeutic Exercise Eight weeks of supervised group exercise. Exercises include strength, aerobic, balance, flexibility, coordination and dual-task activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (Numering Rating Scale)	It is a numerical scale ranging from 1 to 10, where 1 represents the absence of pain and 10 represents the highest intensity.	Baseline and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing Scale	This scale indicates the extent to which each of the 13 thoughts described is experienced. They are rated on a Likert scale ranging from 0 ('never') to 4 ('always'). The total score is calculated, with 52 being the maximum score. Low scores indicate low levels of catastrophising, whilst high scores indicate high levels of catastrophising.	Baseline and Week 8
Chronic Pain Coping Questionnaire	The scale assesses the way in which patients cope with pain. It comprises six factors to be measured: religion, catharsis, distraction, mental self-control, self-affirmation and information-seeking. Within each factor there are between 5 and 6 items scored on a scale of 0 to 4, where 0 means 'strongly disagree' and 4 means 'strongly agree'. Greater use of active strategies such as distraction, self-affirmation or seeking information is associated with better emotional adjustment. Taken together, the score obtained provides an insight into how pain is coped with.	Baseline and Week 8
Tampa Scale for Kinesiophobia (TSK-11)	11-item self-report questionnaire that assesses perceptions of frailty and the tendency to avoid movement for fear of injury or increased pain. Each item is scored on a 4-point scale (1: strongly disagree; 4: strongly agree). A high score on the TSK-11 indicates a greater fear of movement, a greater perception of physical frailty and a more pronounced tendency to avoid activities for fear of pain or injury. Conversely, low scores reflect lower kinesiophobia and a more confident attitude towards movement.	Baseline and Week 8
Chronic Pain Self-Efficacy Questionnaire	This questionnaire consists of 19 items designed to assess the patient's confidence in their own ability to carry out various activities and manage the consequences of persistent pain. The scale is divided into three main domains or subscales: self-efficacy for pain control, for physical function and for symptom management. Each item is rated on a scale ranging from 0 ('completely unable') to 10 ('completely able'). A high score on this scale indicates a greater perceived ability to manage pain, maintain activity and manage symptoms, whilst low scores reflect lower confidence, greater dependence and poorer coping.	Baseline and Week 8
Depression Anxiety Stress Scale (DASS-21)	The DASS-21 scale measures patients' emotional state and is used to assess three distinct areas: depression, anxiety and stress. This scale consists of 21 questions divided into three groups of seven items each. For each question, the patient must assign a score from 0 to 3, where 0 means that 'nothing has happened' and 3 means that 'it has happened a lot or most of the time'. Once completed, the points for each section (depression, anxiety and stress) are added together and the result is multiplied by 2 to obtain the final score for each category. Higher scores on each subscale indicate a greater presence of symptoms of depression, anxiety or stress, whilst lower scores reflect a better emotional state.	Baseline and Week 8
Fear Avoidance Beliefs Questionnaire (FABQ)	This scale is based on patients' beliefs about how their pain affects their physical activity and work. This questionnaire consists of 16 items, of which 5 relate to beliefs regarding physical activity (FABQ-PA) - these are the items we will be assessing. Each item is rated on a Likert scale from 0 to 6, where 0 means 'strongly disagree' and 6 means 'strongly agree'. High scores indicate a high level of beliefs that lead to avoidance of activity.	Baseline and Week 8
Clinical Global Impression Scale (CGI)	This scale assesses two aspects: the severity of the illness prior to treatment and the overall improvement following the intervention. It is a Likert-type scale ranging from 0 to 7. To assess the severity of the illness, 0 corresponds to 'not assessed' and 1 to 'normal, not ill', progressing up to 7, which represents 'among the most severely ill patients'. As regards overall improvement, 0 corresponds to 'not assessed', 1 to 'much better' and 7 to 'much worse'. It is a useful tool for assessing severity and response to treatment due to its practicality and clinical validity.	Baseline and Week 8
Qualitative outcomes from focus groups	The focus-group sessions will be transcribed verbatim in full by a single researcher from the audio recordings. The transcripts will then be coded inductively and analysed independently by the research team. The analysis will begin at the most descriptive level, identifying units of meaning, which will be grouped into thematic codes-clusters of units of meaning referring to the same content, and progressively organised into categories, themes, and sub-themes until the main themes emerge. Beyond this descriptive coding, the analysis will move to an interpretive, inferential level, in which the team draws inferences about the meaning of the emerging themes rather than merely describing them. As this qualitative strand forms part of a mixed-methods design, these qualitative inferences will subsequently be integrated with the quantitative findings to generate meta-inferences, so that each strand informs and contextualises the other.	Week 8

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria Aragón
• Collaborators: Universidad San Jorge
• Investigators: Principal Investigator: Sandra S Calvo, Phd, University Zaragoza; Principal Investigator: Carolina C Jiménez-Sánchez, Phd, San Jorge University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Actual): May 30, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: August 10, 2026
• First Submitted That Met QC Criteria: August 10, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 19, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Depressive Disorder; Physical therapy; Therapeutic exercise; Persistent Pain; Neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mental Disorders; Mood Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Depressive Disorder
• Other Study ID Numbers: UZ-USJ_Pain-Mental Healht-Phys

Drug and device information, study documents

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