Effects of Pressure Release of Myofascial Trigger Points on Mechanical Neck Pain. Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Visual analogue scale. Post treatment
研究概览
简要总结
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
详细描述
With the present investigation it is wondered whether the choice of manual therapy techniques, specifically the pressure release of myofascial trigger points in the upper trapezius and sternocleidomastoid muscles, provide significant benefits in combination with therapeutic exercise and postural hygiene (treatment group), as opposed to the unique application of therapeutic exercise and postural hygiene (control group), thus constituting a treatment of choice in patients with mechanical neck pain.
A treatment protocol of one session per week will be carried out, and a follow-up two weeks after the end of the treatment protocol.
If, as postulated, pressure release is more effective than the treatment received by the control group, the choice of this type of technique for myofascial pain syndrome would benefit a high percentage of people who often come asking for treatment in pain treatment centers. Pressure release provides a painless manual stimulus, thus effectively resolving the symptomatology of myofascial trigger points without the need for invasive treatments or medication, which may have more contraindications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The selection of participants and the randomisation sequence will be carried out by the principal investigator using the patient's unique identity number in the centre's programme as a code. After randomisation, participants will be sent by another therapist in the centre to each intervention room without knowing which treatment they will receive. The therapists in charge of delivering the interventions will not know which patient has been assigned to them.
Although both therapists and patients will not know which group they are assigned to, obviously the therapist, given the nature of the intervention and the need to know and master the technique, knows which treatment to apply to each subject.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Visual analogue scale. Post treatment
时间窗: Up to 4 weeks. After the end protocol of four treatment sessions
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.
Cervical Disability Index. Base
时间窗: Baseline. Prior to the first treatment session
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).
Pain catastrophising scale. Base
时间窗: Baseline. Prior to the first treatment session.
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.
Pain catastrophising scale. Follow up
时间窗: Follow-up two weeks after the end of the four-session treatment protocol
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.
Tampa Kinesiophobia Scale (ETK-11). Post treatment
时间窗: Up to 4 weeks. After the end protocol of four treatment sessions
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.
Cervical Disability Index. Post treatment
时间窗: Up to 4 weeks. After the end protocol of four treatment sessions
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).
Pain catastrophising scale. Post treatment
时间窗: Up to 4 weeks. After the end protocol of four treatment sessions
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.
Tampa Kinesiophobia Scale (ETK-11). Follow up
时间窗: Follow-up two weeks after the end of the four-session treatment protocol
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.
Visual analogue scale. Base
时间窗: Baseline. Prior to the first treatment session
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.
Pressure pain threshold. Post treatment
时间窗: Up to 4 weeks. After the end protocol of four treatment sessions
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.
Tampa Kinesiophobia Scale (ETK-11). Base
时间窗: Baseline. Prior to the first treatment session.
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.
Visual analogue scale. Follow up
时间窗: Follow-up two weeks after the end of the four-session treatment protocol
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.
Pressure pain threshold. Base
时间窗: Baseline. Prior to the first treatment session
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.
Pressure pain threshold. Follow up
时间窗: Follow-up two weeks after the end of the four-session treatment protocol
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.
Cervical Disability Index. Follow up
时间窗: Follow-up two weeks after the end of the four-session treatment protocol
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).
次要结局
- Swallow-wall distance. Base(Baseline. Prior to the first treatment session.)
- Swallow-wall distance. Post treatment(Up to 4 weeks. After the end protocol of four treatment sessions)
- Cervical flexion-extension. Post treatment(Up to 4 weeks. After the end protocol of four treatment sessions.)
- Side bending. Post treatment(Up to 4 weeks. After the end protocol of four treatment sessions.)
- Cervical flexion-extension. Base(Baseline. Prior to the first treatment session.)
- Cervical rotation. Post treatment(Up to 4 weeks. After the end protocol of four treatment sessions.)
- Side bending. Base(Baseline. Prior to the first treatment session.)
- Swallow-wall distance. Follow up(Follow-up two weeks after the end of the four-session treatment protocol)
- Cervical flexion-extension. Follow up(Follow-up two weeks after the end of the four-session treatment protocol.)
- Cervical rotation. Follow up(Follow-up two weeks after the end of the four-session treatment protocol.)
- Cervical rotation. Base(BaselinePrior to the first treatment session.)
- Side bending. Follow up(Follow-up two weeks after the end of the four-session treatment protocol.)
研究者
Iván Batuecas Sánchez
PhD student, Principal investigator
Universidad Complutense de Madrid