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Chronic Back PainNCT07504094

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

A study testing Pain Neuroscience Education (PNE), Healthy Habits and Psychological Intervention and Therapeutic Exercise in people with Chronic Back Pain and Chronic Pain, run by Universidad de Zaragoza at 2 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Back Pain, Chronic Pain, Back Pain
What is being tested?
Pain Neuroscience Education (PNE), Healthy Habits and Psychological Intervention and Therapeutic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesSpain
Study dates
1 Apr 2026to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • CS Teruel Centro

    Teruel, Aragon, 44001

  • Centro de Salud Teruel Ensanche

    Teruel, Aragon, 44002

Other trials in Spain

About this study

Official title: 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.

Being tested
Pain Neuroscience Education (PNE), Healthy Habits and Psychological Intervention, Therapeutic Exercise
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
Medical subject headings
Chronic Pain, Back Pain, Low Back Pain, Bronchiolitis Obliterans Syndrome, Musculoskeletal Pain, Kinesiophobia, Sleep Initiation and Maintenance Disorders, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pain Neuroscience Education (PNE)Behavioural

    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

  • Healthy Habits and Psychological InterventionBehavioural

    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

  • Therapeutic ExerciseBehavioural

    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.

Study groups in NCT07504094
Study groupRoleWhat they receive
Multidisciplinary Active Coping ProgramExperimentalAll participants receive the full sequential multidisciplinary intervention comprising four components delivered across four phases.
Receives: Behavioral: Pain Neuroscience Education (PNE); Behavioral: Healthy Habits and Psychological Intervention; Behavioral: Therapeutic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (13)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. 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.

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

  12. 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.

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

  13. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start1 Apr 2026
  3. Primary completion31 Jul 2026
  4. Study completionFeb 2028 (estimated)

Resources

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
no control group, all participants receive the full intervention
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07504094
Sponsor's protocol ID
C.I.PI26/047
Status last verified
Mar 2026
First submitted
20 Mar 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Louw A, Riera-Gilley V. Pain Neuroscience Education: Teaching People About Pain. J Pain Palliat Care Pharmacother. 2024 Sep;38(3):292-301. doi: 10.1080/15360288.2024.2424853. Epub 2024 Nov 11.

    PubMed 39526886

  • 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.

    PubMed 28436583

  • 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.

    PubMed 32331323

Questions about this trial

What is this clinical trial studying?

A study testing Pain Neuroscience Education (PNE), Healthy Habits and Psychological Intervention and Therapeutic Exercise in people with Chronic Back Pain and Chronic Pain, run by Universidad de Zaragoza at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

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 (time frame: Baseline, end of program, 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07504094, which also lists 3 linked publications.

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 4 Sep 2026.

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