Pain Science Education and Therapeutic Exercise in Adults With Musculoskeletal Pain

NCT07788781 | Completed DMC

• 1 other identifier: 205-2025-04
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Musculoskeletal Pain

Keywords

Pain Neuroscience Education; Therapeutic Exercise Kinesiophobia; Fear-Avoidance Beliefs; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 9

Secondary Outcomes (7)

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

  Baseline and Week 9

• Fear-Avoidance Beliefs Assessed With the Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline and Week 9

• Muscle Strength Assessed Using a Linear Velocity Transducer

  Baseline and Week 9

• Recruitment Feasibility

  Through completion of the recruitment period

• Adherence to the Intervention

  Up to 8 weeks

Study Arms (2)

Arm 1 Experimental

EXPERIMENTAL

Arm 1 Experimental: Therapeutic Exercise + Pain Neuroscience Education

Behavioral: Pain Neuroscience Education (PNE) + Therapeutic Exercise

Arm 2 - Control

ACTIVE COMPARATOR

Therapeutic Exercise Alone

Behavioral: Therapeutic Exercise

Interventions

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.

Also known as: Arm 1

Arm 1 Experimental

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.

Also known as: Arm 2

Arm 2 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (1)

Studio Pilates Fisioterapia

Pontevedra, Pontevedra, 36005, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise Therapy; DMAC2L protein, human

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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)

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start: May 1, 2026
• Primary Completion: July 3, 2026
• Study Completion: July 3, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)