Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus With 6 Week Follow Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Neck Disability Index (NDI)
研究概览
简要总结
Participants will be 18-59 years old who are recruited through a convenience sample from the UMHB/Belton community. There will be a randomized control trial consisting of three groups. Each participant will be assigned based on their order of entry to the study group assignment and then randomly organized via computer generation into 3 groups of 20 participants including a control group, a dry needling group (DN), and a dry needling E-stim group (DN-ES), resulting in approximately 60 total participants. Participants in the DN and DN-ES groups will be treated four times; at weeks 0, 2, 4 and 6 of the study. Data will be collected at weeks 4, 6 and 12 in all groups.
详细描述
Interventions per group:
Control: none
DN: 20-30 seconds of DN per trigger point in each involved trapezius muscle, needles rest in situ 10 min, needles removed.
DN-ES: 20-30 seconds of DN per trigger point (TrP) in each involved trapezius muscle, DC ES attached to needles crossing the most reactive TrP and current set to strong, but comfortable intensity at 10 MHz for 10 min, needles removed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-59 years old
- •have an active email account
- •have at least one palpable active trigger point (TrP) (located in one or both upper trapezius)
- •English speaking
排除标准
- •current treatment or diagnosis related to cancer
- •active local or systemic infection
- •neurologic deficit
- •cognitive deficit
- •connective tissue disease and/or autoimmune disorder
- •tobacco use
- •received previous DN treatments within 6 weeks of the study,
- •experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
- •Neck Disability Index score < 6
- •Numerical Pain Rating Scale score < 3
研究组 & 干预措施
Dry Needling (DN)
Subjects will receive dry needling treatment every 2 weeks for 6 weeks (weeks 0, 2, 4, 6).
Outcomes will be measured at baseline (week 0), 4 weeks after initiation of study (week 4), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
干预措施: Dry Needling (DN) (Procedure)
Control
Dry Needling with Intramuscular ES (DNES)
Subjects will receive dry needling treatment with electrical stimulation every 2 weeks for 6 weeks (week 0, 2, 4, 6)
Outcomes will be measured at baseline (week 0), 4 weeks after initiation of study (week 4), 6 weeks after initiation of study (week 6), and 6 weeks after last treatment (week 12).
干预措施: Dry needling with Intramuscular electrical stimulation (DNES) (Procedure)
结局指标
主要结局
Change in Neck Disability Index (NDI)
时间窗: 6 weeks
Between group difference in within group disability changes. The NDI is a questionnaire with 10 items including personal care, pain, reading, lifting, headaches, concentration, sleeping, work, driving, and recreation. Each section is scored on a 0 to 5 rating scale. Zero means 'No pain' and 5 means 'Worst imaginable pain'. Al the points can be summed to a total score. The test can be reported as a raw score, with a maximum score of 50, or as a percentage.
Change in numerical pain rating scale (NPRS)between groups
时间窗: 6 weeks
Between group difference in within group pain changes. The NPRS is an 11 point (0-10) scale with 10 meaning "the worst imaginable pain" and 0 meaning "no pain". It is reported as a whole number out of 10, and multiple ratings, i.e. worst, average, and best pain scores over the past 48 hours, can be averaged and reported as a single score.
次要结局
- Maintenance of improvement in pain scores (NPRS)(Compare 6 week data to 12 week data)
- Maintenance of improvement in disability (NDI)(Compare 6 week data to 12 week data)
研究者
Kindyle Brennan
Associate Professor, Doctor of Physical Therapy Program
University of Mary Hardin-Baylor