About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy
Severe illnesses: diabetes, cancer, neurological conditions, depression, etc.
Subjects impairments or disorders
Subjects who have received physiotherapy treatment within the last month
Trial design
Parallel
Treatments tested in this trial
Education
BehavioralThe 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.
Excercise
Other interventionThe 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.
Placebo
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Demographic data
Participants will complete a demographic questionnaire, including descriptive variables such as age, sex, weight, height, level of physical activity, comorbidities, duration of pain, side of pain, and smoking status.
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.
Beliefs about specific exercises in relation to pain will be assessed using a custom questionnaire. The questionnaire evaluates the participants' beliefs regarding the specific exercises they will perform. Participants will first be shown photographs of the exercises they are required to do, and then they will respond to the questionnaire by selecting a number on a visual analogue scale from 1 to 10, where 1 indicates "strongly disagree" and 10 indicates "strongly agree." Higher scores reflect stronger beliefs about the exercises in relation to their pain. This questionnaire was specifically designed for this study and is being used for data collection.
Average pain intensity over the last 7 days as assessed by the numerical pain rating scale (NPRS)
Average pain intensity over the last 7 days will be assessed using the Numerical Pain Rating Scale (NPRS). This scale evaluates both the average pain intensity experienced by the participant over the last 7 days, using a 10-point scale where 0 represents no pain and 10 represents the maximum possible pain. Higher scores correspond to greater pain intensity.
Worst Pain Intensity in the Last 7 Days as Assessed by the Numerical Pain Rating Scale (NPRS)
The worst pain intensity over the last 7 days will be assessed using the Numerical Pain Rating Scale (NPRS). This scale evaluates the worst pain intensity experienced by the participant over the past 7 days, using a 10-point scale where 0 represents no pain and 10 represents the maximum possible pain. Higher scores indicate greater pain intensity.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.