The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Low back pain Oswestry Disability Index Questionnaire at Baseline
研究概览
简要总结
The goal of this study is to enroll and randomize 99 participants with non-specific low back pain into a multimodal strategy of treatment consisting of a combination of dry needling (DN) and spinal manipulation therapy (SMT), DN only, and SMT only, followed by an at home exercise program. All groups will receive their respective treatment twice a week for 2 weeks followed by a 2-week home exercise program. Primary outcomes include clinical subjective (Oswestry Disability Index, numeric pain intensity rating) and mechanistic (lumbar multifidus, erector spinae, and gluteus medius muscle activation) measures assessed at baseline, 1, 2, and 4 weeks. Timepoints at 2-weeks and 4-weeks will be compared to baseline measures to determine effectiveness of the combination group against the other single treatment groups. Exercise compliance will be measured by participants self-reporting adherence to the program by selecting average number of days per week the exercises are completed.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of nonspecific low back pain defined as pain between the twelfth rib and buttocks with or without symptoms into one or both legs
- •Current patient-reported pain rating score greater than 3 based on the numeric pain rating score 0-10 scale
- •Oswestry Disability Index > 20%
排除标准
- •Prior surgery to the lumbosacral spine
- •Pregnancy
- •Currently receiving mind-body or exercise treatment for low back pain with a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
- •Signs of neurogenic low back pain arising from clinical examination (e.g., positive straight leg raise test, diminished muscle stretch reflex, etc.)
- •Evidence of significant spinal pathology (e.g., spinal fracture, infection, etc.).
结局指标
主要结局
Low back pain Oswestry Disability Index Questionnaire at Baseline
时间窗: Baseline
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Numeric pain rating scale at 2-weeks
时间窗: 2-weeks
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Numeric pain rating scale at Baseline
时间窗: Baseline
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Low back pain Oswestry Disability Index Questionnaire at 1-week
时间窗: 1-week
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Low back pain Oswestry Disability Index Questionnaire at 2-weeks
时间窗: 2-weeks
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Numeric pain rating scale at 4-weeks
时间窗: 4-weeks
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Numeric pain rating scale at 1-week
时间窗: 1-week
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Low back pain Oswestry Disability Index Questionnaire at 4-weeks
时间窗: 4-weeks
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
次要结局
- Lumbar multifidus muscle change in thickness at Baseline(Baseline)
- Gluteus medius muscle change in thickness at 2-weeks(2-weeks)
- Erector spinae muscle change in thickness at 4-weeks(4-weeks)
- Lumbar multifidus muscle change in thickness at 2-weeks(2-weeks)
- Lumbar multifidus muscle change in thickness at 4-weeks(4-weeks)
- Gluteus medius muscle change in thickness at 4-weeks(4-weeks)
- Erector spinae muscle change in thickness at Baseline(Baseline)
- Gluteus medius muscle change in thickness at Baseline(Baseline)
- Erector spinae muscle change in thickness at 2-weeks(2-weeks)
研究者
Jedidiah Farley
Research Fellow
University of Utah