Multimodal Physiotherapy and Pain Coping in Primary Care
ConditionChronic Musculoskeletal Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversitat Jaume I
About this trial
This quasi-experimental, multicenter study aims to evaluate the effectiveness of a multimodal physiotherapy intervention-based on pain neuroscience education and therapeutic exercise-on health-related quality of life in patients with persistent musculoskeletal pain treated in Primary Care.
The study will be conducted in four Primary Care physiotherapy units in the Valencian Community (Spain). A total of at least 68 participants aged 18 to 70 years with nonspecific persistent musculoskeletal pain lasting at least six months will be recruited.
The intervention will consist of a structured multimodal physiotherapy program including educational sessions on pain neuroscience and guided therapeutic exercise. The main outcome will be health-related quality of life, assessed using the SF-36 Health Survey. Secondary outcomes will include pain catastrophizing (Pain Catastrophizing Scale), kinesiophobia (Tampa Scale for Kinesiophobia), and central sensitization (Central Sensitization Inventory), among others.
Data will be collected using the REDCap electronic platform at three time points: baseline (pre-intervention), immediately after the intervention, and six months post-intervention. Statistical analysis will include descriptive statistics, bivariate analyses, and paired comparisons to assess changes over time.
The study seeks to generate evidence on the feasibility and potential effectiveness of implementing a multimodal physiotherapy intervention for active coping with chronic musculoskeletal pain in the context of Primary Care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Oncologic pain.
Spinal fracture or surgical intervention within the 12 months prior to the intervention.
Cognitive impairment that prevents comprehension of the intervention content (in case of doubt, the Mini-Mental State Examination will be administered, requiring a minimum score of 25).
Physical performance deficit that prevents execution of the intervention (minimum requirement: completion of the Timed Up and Go test within the normal time of 10 seconds).
Trial design
Design model
Single group
Treatments tested in this trial
Multimodal Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise
BehavioralThe intervention consists of a multimodal physiotherapy program designed to promote active coping and improve health-related quality of life in patients with persistent musculoskeletal pain. It includes educational sessions on pain neuroscience aimed at reconceptualizing pain and reducing maladaptive beliefs, combined with supervised therapeutic exercise focused on mobility, strength, and functional recovery. The program will be delivered in small group sessions by trained physiotherapists in Primary Care settings over several weeks. Participants will be encouraged to progressively integrate the exercises and concepts into their daily activities to foster self-management and long-term adherence.
Treatment groups
68 Participants
are divided into 1 treatment groupGroup A: Multimodal Physiotherapy InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Health-Related Quality of Life Measured With the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The instrument provides eight domain scores and a total score, each ranging from 0 to 100. Higher scores indicate better perceived health-related quality of life.
Time frame
Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.Secondary outcomes
1
Pain Catastrophizing Measured With the Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), a 13-item questionnaire evaluating rumination, magnification, and helplessness related to pain. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing.
Time frame
Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.2
Kinesiophobia Assessed Using the Tampa Scale for Kinesiophobia (TSK-11 or TSK-17)
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK), a validated questionnaire measuring fear of movement and reinjury. Higher scores indicate greater kinesiophobia.
Time frame
Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.3
Central Sensitization Assessed With the Central Sensitization Inventory (CSI)
Central sensitization will be assessed using the Central Sensitization Inventory (CSI), a 25-item questionnaire evaluating symptoms associated with central sensitivity syndromes. Scores range from 0 to 100, with higher scores indicating greater central sensitization.
Time frame
Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.4
Pain Intensity Measured Using the Numerical Rating Scale (NRS 0-10)
Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS), where participants rate their average pain during the previous week from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity.
Time frame
Baseline (before the intervention), immediately after the intervention, and 6 months after the intervention.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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