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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Zaragoza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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

  • 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

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Multidisciplinary Active Coping ProgramExperimental treatment 3 interventions

Trial outcomes

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.

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
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

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.

Time frame
Immediately before and after PNE sessions (March 2026)

Sponsors and contacts

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