Effects of Education and Exercise on Pain, Psychosocial Factors, and Upper Limb Function in Non-specific Neck Pain.

NCT06889389 | Recruiting

• 2 other identifiers: PI 90/2024DPC.JGJ.241001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Pain neuroscience education is currently one of the techniques being explored in physiotherapy for pain management. The benefits of this technique are gradually becoming evident in various published studies. So far, it has been widely studied for its short-term effects, but the education provided has typically been generic, not focused on exercise. However, it is suggested that this technique should be combined with exercise to achieve the expected outcomes. Therefore, pain education should be tailored to the specific physical activities the subject will perform to maximise its effectiveness. The primary aim of this study is to analyse the outcome of combining exercise with tailored pain neuroscience education on aspects such as pain, kinesiophobia, catastrophizing, exercise conceptualization, and upper limb function in subjects with neck pain. The secondary aim is to evaluate the relationship between kinesiophobia and catastrophizing and their impact on the results of various upper limb performance tests. Finally, the effects of therapeutic exercise alone will be compared with those of therapeutic exercise combined with pain neuroscience education, focusing on pain, kinesiophobia, catastrophizing, and exercise conceptualization. A double-blind, randomised clinical trial has been designed, in which three intervention protocols will be applied to 81 subjects with non-specific neck pain: education with exercise, exercise alone, and placebo alone. Subjects with non-specific neck pain who meet the inclusion criteria will be enrolled. Demographic characteristics of the subjects, as well as pain, kinesiophobia, catastrophizing, and upper limb performance test scores, will be assessed. This study aims to explore the potential relevance of a pain neuroscience education session prior to therapeutic exercise, as well as to influence the clinical recommendations made by clinicians during treatment.

Conditions

Neck Pain; Patient Education; Exercise Therapy; Fear; Pain

Keywords

Neck pain; Pain neuroscience education; Exercise therapy; Kinesiophobia; Pain catastrophizing

Outcome Measures

Primary Outcomes (5)

• Change in Kinesiophobia Level from Baseline to the End of the Interventions as Assessed by the Tampa Scale for Kinesiophobia (TSK-11SV)

  The level of kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK-11SV). This scale evaluates kinesiophobia (fear of movement) through 11 statements, which participants must rate on a Likert scale from 1 to 4, where 1 indicates strongly disagree and 4 indicates strongly agree. Higher scores reflect greater kinesiophobia (minimum score: 11; maximum score: 44). The validated Spanish version of the scale will be used.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

• Change in Pain Beliefs from Baseline to the End of the Interventions as Assessed by the Pain Beliefs Questionnaire (PBQ).

  Pain beliefs will be assessed using the Pain Beliefs Questionnaire (PBQ), which evaluates beliefs regarding the causes, consequences, and necessary treatment of pain. The questionnaire is divided into two subscales: "organic" and "psychological." It consists of 12 items, with 8 items belonging to the "organic" subscale and 4 to the "psychological" subscale. The PBQ uses a 6-point Likert scale ranging from "Always" to "Never," corresponding to scores of 6 and 1, respectively. Higher scores on each subscale indicate that the respondent considers the corresponding pain-related beliefs to be of greater importance.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

• Change in Catastrophizing Level from Baseline to the End of the Interventions as Assessed by the Pain and Catastrophizing Scale (PCS).

  The level of catastrophizing will be assessed using the Pain and Catastrophizing Scale (PCS). This scale evaluates catastrophizing in response to pain and the negative and exaggerated perception of the painful experience. It consists of 13 statements describing different thoughts and feelings that may be associated with pain. The participant is required to indicate the extent to which they experience these thoughts and feelings when they are in pain. Each statement is rated on a Likert scale from 0 to 4, where 0 means "not at all" and 4 means "all the time." Higher scores indicate a higher degree of catastrophizing. The validated Spanish version of the scale will be used.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

• Change in Pain Intensity from Baseline to the End of the Interventions as Assessed by the Numerical Pain Rating Scale (NPRS).

  Pain intensity will be assessed using the Numerical Pain Rating Scale (NPRS). This scale evaluates the intensity of pain experienced by the participant, using a 10-point scale, where 0 represents no pain and 10 represents the maximum possible pain. Higher scores correspond to greater pain intensity.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

• Change in Evoked Pain Intensity from Baseline to the End of the Interventions as Assessed by the Numerical Pain Rating Scale (NPRS)

  Evoked pain will be assessed using the Numerical Pain Rating Scale (NPRS). Participants will be asked to perform a movement that evokes pain related to their condition. Pain intensity will then be evaluated on a 10-point scale, where 0 represents no pain and 10 represents the maximum possible pain. Higher scores correspond to greater pain intensity.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

Secondary Outcomes (7)

• Demographic data

  Baseline (Day 1).

• Change in Beliefs About Specific Exercises from Baseline to the End of the Interventions as Assessed by the Custom Questionnaire on Beliefs About Specific Exercises.

  Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).

• Average pain intensity over the last 7 days as assessed by the numerical pain rating scale (NPRS)

  Baseline (Day 1).

• Worst Pain Intensity in the Last 7 Days as Assessed by the Numerical Pain Rating Scale (NPRS)

  Baseline (Day 1).

• Functional Performance of the Upper Extremity as Assessed by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)

  Post-education/rest (Day 1).

Study Arms (3)

Education and Exercise group

EXPERIMENTAL

The investigator will proceed with pain neuroscience education focused on concepts related to movement-related fear and the benefits of exercise for 20 minutes. Specifically, the exercises presented in the generic part of the procedure will be discussed. To assess whether the education has produced changes in the subjects' beliefs, they will be reassessed regarding their beliefs about the exercises in relation to their neck pain following the education session. Subsequently, the subject will undergo the performance tests (Closed Kinetic Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated Medicine Ball Throw), which will be carried out by a second investigator. The exercise intervention will then proceed using variations of the performance tests, also conducted by the second investigator. Specifically, the load or execution time will be increased until the participant reports a perceived fatigue of 4-6 (moderate to strong) on the modified Borg scale.

Behavioral: Education; Other: Excercise

Exercise group

EXPERIMENTAL

This group does not include pain neuroscience education. Following the initial assessment, the subject will be left alone for 20 minutes with instructions to think about the exercises but not to perform them. Subsequently, the subject will undergo the performance tests (Closed Kinetic Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated Medicine Ball Throw), which will be carried out by a second investigator. The exercise intervention will then proceed using variations of the performance tests, also conducted by the second investigator. Specifically, the load or execution time will be increased until the participant reports a perceived fatigue of 4-6 (moderate to strong) on the modified Borg scale.

Other: Excercise

Control group

PLACEBO COMPARATOR

This group does not include pain neuroscience education or exercise. Following the initial assessment, the subject will be left alone for 20 minutes with instructions to think about the exercises but not to perform them. Subsequently, subjects in this group will receive a placebo intervention. A TENS device will be placed on them and kept turned off for 15 minutes. Subjects will be informed that the device is working at a very low intensity, too weak to be perceived. Additionally, performance tests will not be assessed in this group.

Other: Placebo

Interventions

Education BEHAVIORAL

The intervention consists of 20 minutes of pain neuroscience education, focused on concepts related to movement-related fear and the benefits of exercise for managing pain. Specific exercises, mentioned in the generic part of the procedure, will be discussed during this session. This intervention aims to modify the subjects' beliefs regarding exercises and their neck pain.

Also known as: Pain Neuroscience Education, Pain Education Therapy

Education and Exercise group

Excercise OTHER

The exercise intervention includes performance tests and variations of these tests used as exercises, such as the Closed Kinetic Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated Medicine Ball Throw. Variations of these performance tests will be implemented, with adjustments made to the load or execution time until the participant reports a perceived fatigue of 4-6 (moderate to strong) on the modified Borg scale.

Also known as: Physical exercise, Physical activity

Education and Exercise group; Exercise group

Placebo OTHER

The placebo intervention involves the application of a TENS device, which will be placed on the participant and kept turned off for 15 minutes. Subjects will be informed that the device is working at a very low intensity, too weak to be perceived. This intervention aims to simulate the experience of treatment without delivering any therapeutic effect.

Control group

Eligibility Criteria

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

You may qualify if:

• Subjects aged between 18 and 65 years
• Subjects with non-specific neck pain at the time of the intervention, scoring at least 3 on the NPRS scale.

You may not qualify if:

• Pregnancy
• Severe illnesses: diabetes, cancer, neurological conditions, depression, etc.
• Subjects impairments or disorders
• Subjects who have received physiotherapy treatment within the last month
• Subjects currently undergoing concurrent physiotherapy treatment for this condition
• Subjects with specific neck pain, such as any traumatic pathology, whiplash, or diagnoses associated with neurological compromise or peripheral nerve damage
• Physiotherapy students or professional physiotherapists

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead

Study Sites (1)

Clínica de Franscisco Ortega Rehabilitación Avanzada S.L.

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Neck Pain; Pain; Kinesiophobia

Interventions

Educational Status; Exercise

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jaime Gascón-Jaén, Physiotherapist, MSc

CONTACT

+34607375894; jaime.gasconj@umh.es

Miguel Delicado-Miralles, PhD

CONTACT

+34679788377; mdelicado@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician will also be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study follows a parallel-group design, where participants are randomly assigned to one of three intervention groups: (1) a control group receiving a placebo intervention (TENS device turned off, but participants are informed it is on at a very low, imperceptible intensity), (2) an exercise-only group, and (3) a group receiving both exercise and pain neuroscience education. The interventions are applied in a single session, and all groups undergo the same assessments before and after the intervention.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 21, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)