Clinical trial NCT06889389: Effects of Education and Exercise on Pain, Psychosocial Factors, and Upper Limb Function in Non-specific Neck Pain.
Official title: Effects of Pain Neuroscience Education and Therapeutic Exercise on Pain, Catastrophizing, Kinesiophobia and Upper Limb Function in Patients With Non-specific Neck Pain.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Patient Education
Exercise Therapy
Fear
Pain
Keywords: Neck pain
Pain neuroscience education
Exercise therapy
Kinesiophobia
Pain catastrophizing
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: In recent years, education in pain neuroscience has been shown to have a positive impact on pain subjects. However, the education provided is often generic and not adapted to exercise, although it is recommended that this therapy should be combined with exercise. Therefore, the aim of this study is to assess the results of the combination of exercise and pain neuroscience education focused on the exercise to be performed by subjects in pain or kinesiophobia. Therefore, the main objective of the study is to evaluate the effects of pain neuroscience education in non-specific neck pain on pain intensity, kinesiophobia, catastrophizing, exercise conceptualization and upper limb functionality itself in subjects with non-specific neck pain. The specific objective is to compare the effect of therapeutic exercise alone with the effect of therapeutic exercise in combination with pain neuroscience education on pain, kinesiophobia, catastrophizing and exercise conceptualization. Similarly, the aim is to determine the relationship between kinesiophobia and catastrophism and the results obtained in upper limb performance tests. For this purpose, the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), the Seated Medicine Ball Throw test (SMBT) and the Single Arm Military Press (SAMP) have been chosen, the first two of which have not been studied in patients with non-specific neck pain to date. This study aims to have an impact on the possible relevance of a pain neuroscience education session prior to therapeutic exercise, as well as on the clinical recommendations made by healthcare professionals during treatment.

DESIGN The study consists of a randomised, double-blind clinical trial. Subjects will be randomised into 3 groups: control group, where subjects will receive a placebo (TENS off, in this case); intervention group 1, where pain neuroscience education (PNE) and exercise will be applied; and intervention group 2, to which only exercise will be applied. The allocation will be blinded to the subject and to one of the two investigators. SELECTION CRITERIA Inclusion criteria: o Adults aged between 18 and 65 years. o Subjects with non-specific neck pain at the time of the intervention reaching at least a 3 on the Numerical Pain Rating Scale (NPRS scale). Exclusion criteria: o Pregnancy o Severe illnesses: diabetes, cancer, neurological, depression, etc... o Cognitive disorders or illnesses. o Subjects who have received physiotherapy treatment in the last month. o Subjects who are receiving concomitant physiotherapy treatment for this pathology. o Subjects with specific neck pain, such as any traumatic pathology, whiplash or with a diagnosis associated with neurological compromise or peripheral nerve damage. o Physiotherapy students or professional physiotherapists. Subjects included in the study must complete the informed consent form, meet the inclusion criteria and not meet the exclusion criteria. Prior to any type of procedure, subjects will be informed about the study and about their right to discontinue their participation and/or request the withdrawal of their data at any time.

DESCRIPTION OF THE PROCEDURE At the beginning, all subjects will sign the informed consent form, demographic data will be recorded by means of an interview and a questionnaire specifically designed for the work. After that, baseline measurements of outcome variables will be taken. Fear of movement and kinesiophobia will be measured with the Tampa Scale of Kinesiophobia (TSK- 11SV), pain catastrophizing with the Pain and Catastrophizing Scale (PCS), and subject's beliefs about pain with the Pain Beliefs Questionnaire (PBQ). The Spanish validated versions of all the aforementioned scales will be used. The Numerical Pain Rating Scale (NPRS) will be used to assess subjects' current pain and spontaneous or evoked pain intensity. Researcher A will then show each subject images of the 3 performance tests they will have to perform, as well as provide an explanation of their execution: Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Single Arm Military Press (SAMP) and Seated Medicine Ball Throw Test (SMBT). Regardless of whether subjects are later assigned to the exercise group or not. These tests are among the most widely used tests to measure upper limb function, although they have not been studied in subjects with non-specific neck pain. The Single Arm Military Press (SAMP) test is the only performance-based measure of upper limb disability that was designed specifically for subjects with neck pain. All these tests involve active movements that could be conditioned by the subject's pain and beliefs related to kinesiophobia, so they could be of great use to observe whether an educational approach decreases upper limb dysfunction. Finally, subjects' beliefs about the exercises explained in relation to their pathology will be assessed by means of a questionnaire specifically designed for this purpose. After this procedure is completed by all participants, they will be randomised into three groups, using a randomisation website (Research Randomizer, n.d.) and will undergo a physiotherapy session that includes different approaches for each group.

In the PNE and exercise group 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 resulted in changes to the subjects' beliefs, they will be reassessed regarding their beliefs about the exercises in relation to their neck pain following the education session. Afterward, subjects will complete psychosocial scales and rate their pain and evoked pain at that moment independently, without the need for the researcher to be present, in order to ensure blinding. Subsequently, the subject will undergo the performance tests in a randomised order (Closed Kinetic Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated Medicine Ball Throw), which will be conducted by a second investigator who is unaware of whether the subject has received education. The exercise intervention will then proceed using variations of the performance tests, also carried out 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. Finally, the participant will autonomously complete the scales, rate their pain and exercise-related questions for the final time.

The exercise 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. Afterward, subjects will complete psychosocial scales and will rate their pain and evoked pain at that moment independently, without the need for the researcher to be present, in order to ensure blinding. Subsequently, the subject will undergo the performance tests in a randomised order (Closed Kinetic Chain Upper Extremity Stability Test, Single Arm Military Press, and Seated Medicine Ball Throw), which will be conducted by a second investigator who is unaware of whether the subject has received education. The exercise intervention will then proceed using variations of the performance tests, also carried out 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. Finally, the participant will independently complete the scales, rate their pain, evoked pain, and exercise-related questions one final time.

The control group does not receive 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. Afterward, subjects will independently complete psychosocial scales and will rate their pain and evoked pain at that moment, without the need for the researcher to be present, in order to ensure blinding. Subsequently, participants in this group will receive a placebo intervention administered by a second investigator. A TENS device will be placed on them and kept turned off for 15 minutes. subjects will be informed that the device is operating at a very low intensity, too weak to be perceived. Additionally, performance tests will not be assessed in this group. Finally, the participant will autonomously complete the scales, rate their pain and exercise-related questions for the final time. Therefore, all groups will be assessed 3 times during the session. The first time they will be accompanied by the first investigator, who will answer any questions that may arise. The second and third time the subject will do it autonomously, unaccompanied by any researcher, to avoid bias.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Kinesiophobia Level from Baseline to the End of the Interventions as Assessed by the Tampa Scale for Kinesiophobia (TSK-11SV)
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
measure: Change in Pain Beliefs from Baseline to the End of the Interventions as Assessed by the Pain Beliefs Questionnaire (PBQ).
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
measure: Change in Catastrophizing Level from Baseline to the End of the Interventions as Assessed by the Pain and Catastrophizing Scale (PCS).
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
measure: Change in Pain Intensity from Baseline to the End of the Interventions as Assessed by the Numerical Pain Rating Scale (NPRS).
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
measure: Change in Evoked Pain Intensity from Baseline to the End of the Interventions as Assessed by the Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
Secondary outcomes:
measure: Demographic data
timeFrame: Baseline (Day 1).
measure: 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.
timeFrame: Baseline (Day 1), post-education/rest (Day 1), and post-intervention (Day 1).
measure: Average pain intensity over the last 7 days as assessed by the numerical pain rating scale (NPRS)
timeFrame: Baseline (Day 1).
measure: Worst Pain Intensity in the Last 7 Days as Assessed by the Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline (Day 1).
measure: Functional Performance of the Upper Extremity as Assessed by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST)
timeFrame: Post-education/rest (Day 1).
measure: Functional Performance of the Upper Extremity as Assessed by the Single Arm Military Press test (SAMP test)
timeFrame: Post-education/rest (Day 1).
measure: Functional Performance of the Upper Extremities as Assessed by the Seated Medicine Ball Throw Test (SMBT)
timeFrame: Post-education/rest (Day 1).
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Clínica de Franscisco Ortega Rehabilitación Avanzada S.L.
state: Alicante
Study officials:
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