Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in patients' cervical functionality between baseline and follow-up period.
研究概览
简要总结
The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine which of these techniques is the most effective in the variables studied. In order to do so, 96 subjects participated in the study, being assigned to the 3 intervention groups. We expected the combined treatment (INYBI instrument + upper cervical manipulation) to be the one to produce the best results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged between 18 and 40 all diagnosed with chronic mechanic cervical pain with an evolution of at least 3 months and who show pain that increases with maintained postures, during movement and during spinal muscles palpation.
排除标准
- •participants that can't read and/or fill in the informed consent, either due to a language and/or cognition alteration or age-related factors.
- •subjects with psychological pathologies, such as hysteria, depression or anxiety.
- •subjects that have received a manual treatment two months before the beginning of the clinical trial.
- •subjects who have been recommended by a physician or an anesthetist to receive any type of analgesic, anti-inflammatory or neuromodulator medication, such as antidepressants, antiepileptics and benzodiazepines. If the patient took in this type of medication in an occasional way 72 hours before the beginning of the study, he/she could participate.
- •the treatment and assessment techniques will be avoided if: fear to vertebral manipulation in the upper cervical area or positive Klein test and other integrity test of the vertebral artery, positive cervical instability test and positive Spurling test (foraminal compression test).
结局指标
主要结局
Changes in patients' cervical functionality between baseline and follow-up period.
时间窗: Baseline and two weeks after the second intervention.
cervical functionality is measured with the Neck Disability Index
次要结局
- Changes in patients' pressure pain threshold between baseline and follow-up periods.(Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.)
- Changes in patients' pain due to movement between baseline and follow-up periods.(Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.)
- Changes in patients' cervical mobility between baseline and follow-up periods.(Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.)
研究者
Juan José Arjona Retamal
Principal Investigator
Universidad Rey Juan Carlos