Chronic Musculoskeletal PainPSE-EXNCT07788781
Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain
A study testing Pain Neuroscience Education (PNE) + Therapeutic Exercise and Therapeutic Exercise in people with Chronic Musculoskeletal Pain, run by University of Vigo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Musculoskeletal Pain
- What is being tested?
- Pain Neuroscience Education (PNE) + Therapeutic Exercise and Therapeutic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2026to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain. A Randomized Controlled Experimental Pilot Study
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.
Read the 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.
- Conditions
- Chronic Musculoskeletal Pain
- Being tested
- Pain Neuroscience Education (PNE) + Therapeutic Exercise, Therapeutic Exercise
- Keywords
- Pain Neuroscience Education, Therapeutic Exercise Kinesiophobia, Fear-Avoidance Beliefs, Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education (PNE) + Therapeutic ExerciseBehavioural
Also called Arm 1
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.
Therapeutic ExerciseBehavioural
Also called Arm 2
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Experimental | Experimental | Arm 1 Experimental: Therapeutic Exercise + Pain Neuroscience Education Receives: Behavioral: Pain Neuroscience Education (PNE) + Therapeutic Exercise |
| Arm 2 - Control | Active comparator | Therapeutic Exercise Alone Receives: Behavioral: Therapeutic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Pain Intensity. Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS), based on the maximum pain experienced during the previous 7 days.
Measured: Baseline and Week 9
Secondary outcomes (7)
Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia (TSK-11)
Kinesiophobia was assessed using the Spanish-validated Tampa Scale for Kinesiophobia (TSK-11), including the total score and its activity avoidance and harm subscales.
Measured: Baseline and Week 9
Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ)
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.
Measured: Baseline and Week 9
Muscle Strength Assessed Using a Linear Velocity Transducer
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.
Measured: Baseline and Week 9
Recruitment Feasibility
Recruitment feasibility was assessed based on the number of individuals assessed for eligibility and the number of participants enrolled and randomized in the study.
Measured: Through completion of the recruitment period
Adherence to the Intervention
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.
Measured: Up to 8 weeks
Dropout Rate
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.
Measured: Up to 8 weeks
Safety of the Intervention
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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 May 2026
- Primary completion3 Jul 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irimia Mollinedo Cardalda, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788781
- Sponsor's protocol ID
- 205-2025-04
- Other IDs
- 205-2025-04
- Acronym
- PSE-EX
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be publicly shared. Participant confidentiality and protection of personal data will be maintained in accordance with applicable data protection regulations and the ethical requirements of the study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain. A Randomized Controlled Experimental Pilot Study
- ClinicalTrials.gov ID
- NCT07788781
- Acronym / sponsor ID
- PSE-EX / 205-2025-04
- Conditions
- Chronic Musculoskeletal Pain
- Keywords
- Pain Neuroscience Education, Therapeutic Exercise Kinesiophobia, Fear-Avoidance Beliefs, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Experimental | Experimental | Behavioral: Pain Neuroscience Education (PNE) + Therapeutic ExerciseArm 1 Experimental: Therapeutic Exercise + Pain Neuroscience Education |
| Arm 2 - Control | Active comparator | Behavioral: Therapeutic ExerciseTherapeutic Exercise Alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience Education (PNE) + Therapeutic ExerciseAlso: Arm 1Participants 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. | Behavioural | Arm 1 Experimental |
| Therapeutic ExerciseAlso: Arm 2Participants 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. | Behavioural | Arm 2 - Control |
Primary outcome
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.
7 secondary outcomes
Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia (TSK-11)
Time frame: Baseline and Week 9
Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and Week 9
Muscle Strength Assessed Using a Linear Velocity Transducer
Time frame: Baseline and Week 9
Recruitment Feasibility
Time frame: Through completion of the recruitment period
Adherence to the Intervention
Time frame: Up to 8 weeks
Dropout Rate
Time frame: Up to 8 weeks
Safety of the Intervention
Time frame: Up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be publicly shared. Participant confidentiality and protection of personal data will be maintained in accordance with applicable data protection regulations and the ethical requirements of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education (PNE) + Therapeutic Exercise and Therapeutic Exercise in people with Chronic Musculoskeletal Pain, run by University of Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: Baseline and Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.