Chronic Back Pain, Chronic Pain, Back Pain, Low Back Pain, Chronic, Musculoskeletal Pain, Kinesiophobia
Conditions
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
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.
Interventions
BEHAVIORALPain Neuroscience Education (PNE)
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
BEHAVIORALHealthy Habits and Psychological Intervention
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
BEHAVIORALTherapeutic Exercise
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.
Sponsors
Universidad de Zaragoza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
no control group, all participants receive the full intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Oncological pain * Cognitive impairment that prevents following the program * Spinal surgery in the last year * Internal electrostimulator device (e.g. pacemaker, spinal cord stimulator)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, end of program, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Change from Baseline in Kinesiophobia as Measured by the Tampa Scale for Kinesiophobia (TSK-11SV) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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 |
| Change from Baseline in Pain Catastrophizing as Measured by the Pain Catastrophizing Scale (ECD) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
| Change from Baseline in Central Sensitization Symptoms as Measured by the Central Sensitization Inventory (CSI) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
| Change from Baseline in Analgesic and Co-adjuvant Medication Use as Recorded by Medication Registry at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
| Change from Baseline in Frequency of Primary Care Consultations (Medical and Physiotherapy) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
| Change from Baseline in Anxiety as Measured by the State-Trait Anxiety Inventory (STAI) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
| 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 | Baseline, end of program, 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. |
| Change from Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI) at End of Program and 6-Month Follow-Up | Baseline, end of program, 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. |
Countries
Spain
Contacts
CONTACTMª Teresa Muñoz Tomás, Fisioterapeuta
CONTACTGAIAP
Outcome results
None listed