Multimodal Intervention for Persistent Musculoskeletal Pain 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 multicenter randomized controlled trial aims to evaluate the effectiveness of a multimodal intervention for the active management of persistent musculoskeletal pain in primary care. The intervention combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits to improve health-related quality of life in adults with persistent nonspecific musculoskeletal pain lasting at least six months.
A total of 146 participants aged 18 to 70 years will be recruited from five primary care centers in the Comunitat Valenciana (Spain) and randomly assigned to either the experimental group or the control group. The primary outcome is health-related quality of life measured using the SF-36 Health Survey. Secondary outcomes include pain intensity, pain catastrophizing, kinesiophobia, central sensitization, emotional symptoms, perceived social support, medication use, and lifestyle-related variables. Assessments will be conducted at baseline, post-intervention, 6 months, and 12 months follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged between 18 and 70 years
Diagnosis of nonspecific persistent musculoskeletal pain lasting at least 6 months
Receiving care in participating primary care centers
Ability to understand study procedures and provide written informed consent
Disqualifiers
Specific musculoskeletal pathology requiring specialized treatment (e.g., fracture, inflammatory rheumatic disease, malignancy)
Neurological disorders affecting movement or pain perception
Severe psychiatric disorders that may interfere with participation
Participation in another structured pain management program during the study period
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Pain Management Program
BehavioralThe multimodal program combines pain neuroscience education, therapeutic exercise, and the promotion of self-care and healthy lifestyle habits. Pain neuroscience education focuses on reconceptualizing pain based on contemporary neurophysiological principles. Therapeutic exercise includes supervised physical activity aimed at improving strength, mobility, and functional capacity. The self-care component addresses lifestyle factors such as physical activity, sleep hygiene, stress management, and healthy nutrition.
Usual Primary Care
Other interventionParticipants in the control group will continue receiving standard primary care treatment as determined by their healthcare providers. This may include medication, medical advice, or referral to other services according to routine clinical practice.
Treatment groups
146 Participants
are divided into 2 treatment groupsGroup A: Multimodal Intervention GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Health-Related Quality of Life
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 measures eight health domains and provides physical and mental component summary scores. Higher scores indicate better health-related quality of life.
Time frame
Baseline, immediately post-intervention, 6 months, and 12 months after interventionSecondary outcomes
1
Pain Intensity
Pain intensity measured using a numerical rating scale (NRS), where higher scores indicate greater pain intensity.
Time frame
Baseline, immediately post-intervention, 6 months, and 12 months after intervention2
Number of Painful Body Areas
Number of body areas with reported pain as self-identified by participants.
Time frame
Baseline, immediately post-intervention, 6 months, and 12 months after intervention3
Pain Catastrophizing
Pain catastrophizing assessed using the Pain Catastrophizing Scale (PCS). Higher scores indicate greater catastrophizing.
Time frame
Baseline, immediately post-intervention, 6 months, and 12 months after intervention4
Kinesiophobia
Fear of movement assessed using the Tampa Scale of Kinesiophobia (TSK). Higher scores indicate greater fear of movement.
Time frame
Baseline, immediately post-intervention, 6 months, and 12 months after interventionSponsors and contacts
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Source ClinicalTrials.gov
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