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Completed

NCT Number: NCT07788781

Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain

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.

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Key information

Conditions

Chronic Musculoskeletal Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Studio Pilates Fisioterapia

Pontevedra, 36005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain Neuroscience Education (PNE) + Therapeutic Exercise

Behavioral

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.

Other names: Arm 1

Therapeutic Exercise

Behavioral

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.

Other names: Arm 2

Primary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 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 outcomes

  1. Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia (TSK-11)

    Time frame: 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.

  2. Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: 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.

  3. Muscle Strength Assessed Using a Linear Velocity Transducer

    Time frame: 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.

  4. Recruitment Feasibility

    Time frame: 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.

  5. Adherence to the Intervention

    Time frame: 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.

  6. Dropout Rate

    Time frame: 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.

  7. Safety of the Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Official study title

Effectiveness of Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain. A Randomized Controlled Experimental Pilot Study

Acronym: PSE-EX

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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