Chronic PainNCT07764848
Physiotherapy Intervention Program for Chronic Pain Associated With Depressive Disorder
A study testing Hybrid Physiotherapy Program in people with Chronic Pain and Persistent Pain, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Persistent Pain, Depressive Disorder
- What is being tested?
- Hybrid Physiotherapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 5 Feb 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 45-75 years
- User of AFDA and ASAPME
- Chronic persistent pain
- Written informed consent provided
Who cannot join
- Severe psychiatric disorders (including schizophrenia)
- Neurological diseases preventing participation
- No internet access
- Mini-Mental State Examination score ≤24
- Acute musculoskeletal disorders
- Rheumatic diseases
Show all 9Show fewer
- Severe respiratory insufficiency
- Inability to understand Spanish
- Pregnancy, immunosuppression, transplantation or active oncological condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Pain, Persistent Pain, Depressive Disorder
- Being tested
- Hybrid Physiotherapy Program
- Keywords
- Chronic Pain, Persistent Pain, Depressive Disorder, Physical therapy, Therapeutic exercise, Neuroscience education
- Medical subject headings
- Chronic Pain, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Physiotherapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Physiotherapy Program | Experimental | Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise Receives: Other: Hybrid Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start5 Feb 2024
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pre-post study.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad San Jorge
- Responsible party
- Principal investigator, Sandra Calvo Carrión, Instituto de Investigación Sanitaria Aragón
- Investigators
- Sandra S Calvo, Phd, Principal investigator, University ZaragozaCarolina C Jiménez-Sánchez, Phd, Principal investigator, San Jorge University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764848
- Sponsor's protocol ID
- UZ-USJ_Pain-Mental Healht-Phys
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07764848
- Acronym / sponsor ID
- UZ-USJ_Pain-Mental Healht-Phys
- Conditions
- Chronic Pain, Persistent Pain, Depressive Disorder
- Keywords
- Chronic Pain, Persistent Pain, Depressive Disorder, Physical therapy, Therapeutic exercise, Neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Collaborators
- Universidad San Jorge
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pre-post study.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Physiotherapy Program | Experimental | Other: Hybrid Physiotherapy ProgramHybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 45-75 years
- User of AFDA and ASAPME
- Chronic persistent pain
- Written informed consent provided
Key exclusion criteria (9 listed)
- Severe psychiatric disorders (including schizophrenia)
- Neurological diseases preventing participation
- No internet access
- Mini-Mental State Examination score ≤24
- Acute musculoskeletal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid Physiotherapy ProgramHybrid 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. | Other | Hybrid Physiotherapy Program |
Primary outcome
Pain Intensity (Numering Rating Scale)
Time frame: Baseline and Week 8
It is a numerical scale ranging from 1 to 10, where 1 represents the absence of pain and 10 represents the highest intensity.
8 secondary outcomes
Pain Catastrophizing Scale
Time frame: Baseline and Week 8
Chronic Pain Coping Questionnaire
Time frame: Baseline and Week 8
Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline and Week 8
Chronic Pain Self-Efficacy Questionnaire
Time frame: Baseline and Week 8
Depression Anxiety Stress Scale (DASS-21)
Time frame: Baseline and Week 8
Fear Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and Week 8
Clinical Global Impression Scale (CGI)
Time frame: Baseline and Week 8
Qualitative outcomes from focus groups
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra S Calvo, Phd principal investigator
University Zaragoza
Carolina C Jiménez-Sánchez, Phd principal investigator
San Jorge University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Physiotherapy Program in people with Chronic Pain and Persistent Pain, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Numering Rating Scale) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.