Effectiveness of Dry Needling for Suboccipital, Levator Scapula, Upper Trapezius, Masseter, Sternocleidomastoid, Splenius Capitis and Cervicis, Temporalis and Frontalis Muscles on Pain and Active Craniocervical Range of Motion in People With Episodic Tension-type Headache
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Pain level
研究概览
简要总结
Tension-type headache is a widespread disorder, with a lifetime prevalence in the general population ranging between 30% and 78%. Tension-type headache also places a financial burden on society and individuals. Myofascial pain can reduce the range of motion and patterns of muscle activation and play an important role in tension-type headache. Based on the previous studies, dry needling can reduce local and referred pain, increase range of motion and improve patterns of muscle activation in patients with myofascial pain syndrome. The effectiveness of dry needling in patients with tension-type headache is not fully known.
Objective: The aim of this study will be to investigate the effectiveness of dry needling on pain, active range of motion, functional disability, and frequency of headache in patients with episodic tension-type headache.
Method: This study will be a double-blind randomized controlled trial. Thirty-six patients with episodic tension-type headache will be randomly divided into two groups: the experimental group (dry needling and routine physical therapy) and the control group (sham dry needling and routine physical therapy). The primary outcomes will be pain intensity and active range of motion of the craniocervical region. Functional disability and frequency of headache will be considered secondary outcomes. Outcomes will be assessed before and one week after the intervention.
详细描述
Study design: The experimental design will be a randomized, sham-controlled, double-blind, parallel assignment design to investigate the effectiveness of dry needling on pain, active range of motion, functional disability, and frequency of headache in patients with episodic tension-type headache. This investigation will be conducted in the physiotherapy clinic located at the School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. The ethical committee at the Iran University of Medical Sciences has approved this study (Ethical Approval Number: IR.IUMS.REC.1400.30).
Participants: The sample size of this investigation was calculated using Stata statistical software (version 14) with an α value of 0.05 to achieve a statistical power of 0.95 and an effect size of 0.2. The results revealed that a minimum of 36 patients with episodic tension-type headache is required. All of the participants will be identified and recruited by posters and word-of-mouth from the University and the surrounding local communities. Eligible participants will be explained the purpose and the examination involved in this investigation, and all eligible participants will sign a written informed consent before entering the study.
Randomization: All eligible episodic tension-type headache patients will be randomized to an experimental group (dry needling of suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis and cervicis, frontalis and temporalis muscle and routine physical therapy) and a control group (sham dry needling of suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis and cervicis, frontalis and temporalis muscle and routine physical therapy) with a ratio of 1:1. Random allocation will be executed by a researcher not involved in the assessments or interventions. Patients will be asked not to provide their grouping information to the assessor to prevent data contamination.
Procedure: Before the examination, the demographic characteristics form, including name, age, occupation, weight, height, smoking, type and duration of pain, and history of other diseases will be recorded. Primary outcomes are pain level and active range of motion of the craniocervical vertebra.
Functional disability, frequency of headache, and side effects of dry needling are considered secondary outcomes. The numeric pain rating scale, manual goniometer, and neck disability index will be used to measure pain level, active range of motion ,and functional disability, respectively. Outcomes will be examined at baseline and one week after the end of the intervention. Patients will be asked about the side effects of dry needling, such as soreness during and after dry needling, bleeding, etc., at the end of the treatment sessions. The examiner will be blinded to the intervention procedure. Patients will also be blinded to which group they belong to.
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)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CTTH based on the International Classification of Headache Disorders, 3rd edition
- •At least one active trigger point in each of the muscles of the sub occipital, sternocleidomastoid, upper trapezius, temporalis, levator scapula, masseter, frontalis, and splenius cervicis and capitis
- •Moderate pain intensity from 30 to 60 based on the numeric pain rating scale
排除标准
- •Needle phobia
- •History of surgery on head, neck, and shoulder
- •cancer, infectious diseases, or systemic diseases
- •History of involvement with other types of primary headaches
- •History of neck radiculopathy and other orthopedic neck injuries (including fractures, facet joint syndrome, etc.) in the past year.
研究组 & 干预措施
Experimental group
The experimental group will include 18 participants with episodic tension-type headache. The treatment will include dry needling of the suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis, and cervicis, frontalis, and temporalis muscles and routine physical therapy. The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes. In each session, three muscles from one side will be needled. Routine physical therapy will include information on nature, management, course of episodic tension-type headaches, and Multimodal care that includes craniocervical exercises and postural correction. The treatment will last two weeks, six sessions, three times a week.
干预措施: dry needling (Other)
Control group
The control group will include 18 participants with episodic tension-type headache. The treatment will include "sham" dry needling of the suboccipital, levator scapula, upper trapezius, masseter, sternocleidomastoid, splenius capitis, and cervicis, frontalis and temporalis muscles and routine physical therapy. The sham dry needling method includes the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes. In each session, three muscles from one side will be needled. Routine physical therapy will include information on nature, management, course of episodic tension-type headaches, and Multimodal care that includes craniocervical exercises and postural correction. The treatment will last two weeks, six sessions, three times a week.
干预措施: sham (placebo) dry needling: (Other)
结局指标
主要结局
Pain level
时间窗: Change between baseline and one week after intervention.
0-100 Numeric Pain Rating Scale will be used to evaluate changes in level of pain from the baseline to one week after the intervention. Zero indicates no pain and 100 indicates maximum pain that the patient experiences.
Active craniocervical range of motion
时间窗: Change between baseline and one week after intervention.
Active craniocervical range of motion of the participants with episodic tension-type headache will be measured using a SAEHAN plastic universal two-arm goniometer with 360° goniometer face and 30-cm (11.81- in) movable arms. For measuring active flexion, extension, lateral flexion, and rotation, the participants will be asked to sit upright on a chair with a padded backrest supporting the thoracic spine with their feet flat on the floor and arms positioned comfortably on the armrests beside them. To minimize the contribution of the thoracic spine, the participant will be securely strapped across the shoulders to the chair using an inelastic belt. All the measured angles will be documented by a third person. The movements will be measured in the following sequences: flexion, extension, left lateral flexion, right lateral flexion, left rotation, and right rotation.
次要结局
- Functional disability(Change between baseline and one week after intervention.)
- Frequency of headache:(Change between baseline and one week after intervention.)