Trigger Point Pain, Myofascial Clinical Trial
Official title:
Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.
The study aims to compare the effectiveness of myofascial trigger point treatment using pressure release versus a control group in patients with mechanical neck pain, randomly assigned. In both groups a protocol of therapeutic exercise and postural correction will be carried out
Status | Recruiting |
Enrollment | 104 |
Est. completion date | September 20, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - Subjects between 18 and 55 years of age in order to avoid degenerative phenomena. - Have suffered from neck pain at least once in the last month. - Active or latent myofascial trigger points in the Upper Trapezius and Sternocleidomastoid muscles. Exclusion Criteria: - Patients with recent trauma (last 6 months) to the upper quadrant or spine. - Patients with pathologies involving malignant neoplasms. - Surgery on the trunk or upper limb in the last six months. - Patients undergoing pharmacological or physiotherapy treatment at the time of the test. - Pregnancy. - No myofascial trigger points in the upper trapezius or sternocleidomastoid muscles. - Refusal to sign the consent form for the study or not being able to do so. |
Country | Name | City | State |
---|---|---|---|
Spain | Fisioterapia Los Molinos | Getafe | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue scale. Base | Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable. | Baseline. Prior to the first treatment session | |
Primary | Visual analogue scale. Post treatment | Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable. | Up to 4 weeks. After the end protocol of four treatment sessions | |
Primary | Visual analogue scale. Follow up | Measure of pain intensity. A mark is placed on a 10-centimetre line with the left end being no pain at all and the right end being the worst pain imaginable. | Follow-up two weeks after the end of the four-session treatment protocol | |
Primary | Pressure pain threshold. Base | Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated. | Baseline. Prior to the first treatment session | |
Primary | Pressure pain threshold. Post treatment | Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated. | Up to 4 weeks. After the end protocol of four treatment sessions | |
Primary | Pressure pain threshold. Follow up | Measurement of pain threshold to pressure with Fischer algometer. The algometer is placed perpendicular to the myofascial trigger point previously marked by the therapist. Once in place, the pressure is increased at a rate of 1 kilogram per second (kg per sec) until the patient begins to feel discomfort. At this point, the application is stopped. Three measurements are taken and the average is calculated. | Follow-up two weeks after the end of the four-session treatment protocol | |
Primary | Cervical Disability Index. Base | Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability). | Baseline. Prior to the first treatment session | |
Primary | Cervical Disability Index. Post treatment | Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability). | Up to 4 weeks. After the end protocol of four treatment sessions | |
Primary | Cervical Disability Index. Follow up | Results on the Northwick Park Cervical Spine Disability Questionnaire, translated and validated in Spanish. The pre-questionnaire consists of 9 questions related to pain intensity, sleep, weight bearing, leisure and social activities, work and driving. Each question has 5 possible answers ranging from 0 to 4, where 0 represents the absence of disability and 4 the maximum degree of disability. Similarly, the subsequent questionnaire consists of 10 questions and the same answers. Taking this into account, the maximum score that can be obtained would be 36 in the pre-questionnaire or 40 in the post-questionnaire (categorised as high disability). | Follow-up two weeks after the end of the four-session treatment protocol | |
Primary | Pain catastrophising scale. Base | It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct. | Baseline. Prior to the first treatment session. | |
Primary | Pain catastrophising scale. Post treatment | It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct. | Up to 4 weeks. After the end protocol of four treatment sessions | |
Primary | Pain catastrophising scale. Follow up | It is the set of cognitive and emotional processes consisting of having negative thoughts about the future that predispose to the chronification of pain. Self-administered scale made up of 13 items, each item scored from 0 to 4. The total score range is from 0 to 52, where higher scores indicate a higher level of catastrophism. It is one of the most widely used to assess the pain catastrophising construct. | Follow-up two weeks after the end of the four-session treatment protocol | |
Primary | Tampa Kinesiophobia Scale (ETK-11). Base | Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance. | Baseline. Prior to the first treatment session. | |
Primary | Tampa Kinesiophobia Scale (ETK-11). Post treatment | Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance. | Up to 4 weeks. After the end protocol of four treatment sessions | |
Primary | Tampa Kinesiophobia Scale (ETK-11). Follow up | Translated into Spanish. It is one of the most frequently used measures to assess pain-related fear of movement in patients with chronic pain. The ETK-11 is an 11-item self-questionnaire in its Spanish version that measures fear of movement and pain. The total score of the ETK-11 is between 11 - 44 points and each item has a likert scale that scores from 1 to 4 (1 = strongly disagree, 4 = strongly agree). Higher scores indicate greater fear of movement and pain. The ETK-11 has two subscales: activity avoidance and harm avoidance. | Follow-up two weeks after the end of the four-session treatment protocol | |
Secondary | Swallow-wall distance. Base | Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological. | Baseline. Prior to the first treatment session. | |
Secondary | Swallow-wall distance. Post treatment | Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological. | Up to 4 weeks. After the end protocol of four treatment sessions | |
Secondary | Swallow-wall distance. Follow up | Patient in a sitting position, back against the wall, the distance in centimetres is measured using a tape measure or ruler between the swallow and the surface of the wall during the maximum effort to bring the head close to the wall. The chin should not be lifted higher than horizontal. The average of both sides gives the final result. A value greater than 15 centimetres is considered pathological. | Follow-up two weeks after the end of the four-session treatment protocol | |
Secondary | Cervical flexion-extension. Base | Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded. | Baseline. Prior to the first treatment session. | |
Secondary | Cervical flexion-extension. Post treatment | Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded. | Up to 4 weeks. After the end protocol of four treatment sessions. | |
Secondary | Cervical flexion-extension. Follow up | Using the "Goniometer pro" mobile app. The patient performs flexion and extension movements and the inclinometer of the mobile device records the degrees of movement. Three measurements are taken and the average is recorded. | Follow-up two weeks after the end of the four-session treatment protocol. | |
Secondary | Cervical rotation. Base | Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded. | BaselinePrior to the first treatment session. | |
Secondary | Cervical rotation. Post treatment | Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded. | Up to 4 weeks. After the end protocol of four treatment sessions. | |
Secondary | Cervical rotation. Follow up | Via mobile application "Goniometer pro". The patient performs a cervical rotation movement to the left and right side and the degrees of movement are recorded by recording the angular translation of the mobile device on the apex of the skull. Three measurements are taken and the mean is recorded. | Follow-up two weeks after the end of the four-session treatment protocol. | |
Secondary | Side bending. Base | Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded. | Baseline. Prior to the first treatment session. | |
Secondary | Side bending. Post treatment | Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded. | Up to 4 weeks. After the end protocol of four treatment sessions. | |
Secondary | Side bending. Follow up | Using the "Goniometer pro" mobile app. The patient performs a lateral tilt movement to the right and left side and the degrees of movement are recorded using the inclinometer on the mobile device. The device is placed vertically on the prominence of the spinous process of the 7th cervical vertebra following the tilt movement. Three measurements shall be taken and the mean shall be recorded. | Follow-up two weeks after the end of the four-session treatment protocol. |
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