Chronic Musculoskeletal Pain
Conditions
Keywords
Pain Neuroscience Education, Therapeutic Exercise Kinesiophobia, Fear-Avoidance Beliefs, Chronic Pain
Brief summary
This randomized controlled pilot trial evaluated the effectiveness of adding pain neuroscience education (PNE) to a therapeutic exercise program in adults with chronic musculoskeletal pain. Participants were randomly allocated in a 1:1 ratio to an experimental group receiving therapeutic exercise plus PNE or to a control group receiving therapeutic exercise alone. The intervention lasted 8 weeks. The primary objective was to evaluate the effect of the intervention on pain intensity. Secondary objectives included evaluating its effects on kinesiophobia, fear-avoidance beliefs, and muscle strength, as well as assessing the feasibility of the study protocol to inform the design of a future larger-scale randomized controlled trial.
Detailed description
This randomized controlled pilot trial was designed to evaluate the added effect of pain neuroscience education (PNE) when incorporated into a structured therapeutic exercise program in adults with chronic musculoskeletal pain. Participants were randomly allocated in a 1:1 ratio to an experimental group or a control group. Both groups participated in the same 8-week therapeutic exercise program. The experimental group additionally received a structured PNE intervention consisting of four educational sessions delivered every two weeks. The PNE program aimed to facilitate the reconceptualization of pain through accessible explanations of the neurophysiological mechanisms involved in pain perception and modulation. The therapeutic exercise program was delivered in supervised group sessions and was primarily focused on strength training, with an additional aerobic exercise component. Exercise frequency, intensity, duration, and progression were individualized according to each participant's characteristics and abilities. The study was designed as a pilot trial to estimate the effects of adding PNE to therapeutic exercise and to assess the feasibility of the study protocol, with the aim of informing the design of a future larger-scale randomized controlled trial.
Interventions
BEHAVIORALPain Neuroscience Education (PNE) + Therapeutic Exercise
Participants in the experimental group received four Pain Neuroscience Education (PNE) sessions over the 8-week intervention period, with one session every two weeks. The educational intervention aimed to facilitate the reconceptualization of pain through accessible explanations of the neurophysiological mechanisms involved in pain perception and modulation. Sessions were delivered online through educational videos and included examples and graphic materials. A brief questionnaire was administered after each session to verify attendance and understanding of the content.
BEHAVIORALTherapeutic Exercise
Participants attended supervised 50-minute therapeutic exercise sessions, usually 1 to 3 times per week, during the 8-week intervention period. The structured program was primarily focused on strength training and also included an aerobic exercise component. Exercise frequency, intensity, duration, and progression were individualized according to each participant's characteristics and abilities.
Sponsors
University of Vigo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants were randomly assigned in a 1:1 ratio to either the experimental group (therapeutic exercise plus pain neuroscience education) or the control group (therapeutic exercise alone)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 years. * Chronic musculoskeletal pain lasting more than 3 months, regardless of pain location. * Provision of written informed consent to participate in the study.
Exclusion criteria
* Psychiatric or psychological condition that could interfere with the performance or understanding of the therapeutic exercise program or the educational intervention. * Degenerative neurological disease or neurological disease affecting the central nervous system. * Recent surgery. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | Baseline and Week 9 | Pain Intensity. Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS), based on the maximum pain experienced during the previous 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia (TSK-11) | Baseline and Week 9 | Kinesiophobia was assessed using the Spanish-validated Tampa Scale for Kinesiophobia (TSK-11), including the total score and its activity avoidance and harm subscales. |
| Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ) | Baseline and Week 9 | Fear-avoidance beliefs were assessed using the Spanish-validated Fear-Avoidance Beliefs Questionnaire (FABQ), including the total score and the physical activity and work subscales. |
| Muscle Strength Assessed Using a Linear Velocity Transducer | Baseline and Week 9 | Dynamic muscle strength was assessed using a linear velocity transducer during four movement patterns: squat, deadlift, bench press, and bench-supported row. Movement velocity was recorded during exercises performed with an Olympic barbell. A load equivalent to 70% of one-repetition maximum (1RM) was used for the squat, bench press, and bench-supported row, and 80% of 1RM for the deadlift. Three attempts were performed for each exercise. |
| Recruitment Feasibility | Through completion of the recruitment period | Recruitment feasibility was assessed based on the number of individuals assessed for eligibility and the number of participants enrolled and randomized in the study. |
| Adherence to the Intervention | Up to 8 weeks | Intervention adherence was assessed based on participants' attendance at the therapeutic exercise sessions and, for participants in the experimental group, attendance at the Pain Neuroscience Education (PNE) sessions. |
| Dropout Rate | Up to 8 weeks | Dropout rate was assessed based on the number of randomized participants who discontinued or did not complete the assigned intervention during the study period. Reasons for discontinuation were recorded whenever possible. |
| Safety of the Intervention | Up to 8 weeks | Safety was assessed by monitoring adverse events and clinical incidents occurring during the intervention period. Potential risks associated with therapeutic exercise included transient muscle soreness or fatigue, while PNE could initially increase attention to pain. Any significant worsening of pain or functional status was monitored during the study. |
Countries
Spain
Outcome results
None listed