跳至主要内容
临床试验/NCT02312895
NCT02312895已完成不适用

Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.

Youngstown State University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2014年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
Oswestry Disability Index (change over time)

研究概览

简要总结

This is a comparative study to determine if there is a difference in pain reduction and disability between dry needling and manual therapy for patients with low back pain. Subjects will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling or manual mobilizations along with patient education and a home exercise program.

详细描述

Procedures:

Subjects will sign the informed consent prior to any examination procedures. Eligibility assessment will be performed by the treating physical therapist and will include the subject filling out the demographic / health history questionnaire, outcome measures, and a clinical examination. The treating physical therapist will use 2 components of the examination for eligibility criteria into the study. The treating therapist will press on the subject's joints in their back to try to elicit their chief complaint. The treating physical therapist will also press on the soft tissue of the subject's back to check for any symptomatic points. A symptomatic point would include recreation of their chief complaint, tenderness, hypersensitivity, or referred pain. The treating physical therapist will then draw an X on the patient's back where the most symptomatic tissue exists. This point will be used by the data collecting physical therapist in order to collect pain pressure threshold of the area.

The data collecting physical therapist will have the subject complete an Oswestry Disability Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold. Each subject will then be allocated to either the manual therapy group or the dry needling group.

Once a subject is assigned to a group, they will receive either dry needling or manual therapy mobilizations by the treating therapist. Each subject will remain in the assigned group as long as they are continuing in the study up to 3 weeks. In addition to the treatments under investigation, a standardized home exercise program will be assigned to each of the subjects by the treating physical therapist. This program will be given to and reviewed with each subject to ensure they understand the exercises and will perform the exercise program 1x/day for the duration they are under the care of the physical therapist for the study. Subjects will be treated on day 1 of their plan of care and subsequent treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than the 3 week data point. Early discharge will occur if the subject achieves resolution of symptoms or if they decide they no longer wish to be a research participant.

Subsequent sessions will involve the collection of outcome data by the data-collecting therapist followed by treatment performed by the treating physical therapist. No adjustments will be made to the treatment protocol in any of the sessions. Subjects will only be scheduled with and treated by the same treating physical therapist each session. In the event that a treating physical therapist is unable to see a subject participating in the study, the subject will be rescheduled for a different time to receive care.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • There will be 72 subjects participating in this study that present with mechanical low back pain, ranging from 18-70 years old. The 72 subjects includes a 20% attrition rate 12 additional subjects. The total needed for analysis is 60 subjects, 30 per group.

排除标准

  • Subjects will be excluded if the examining therapist cannot provoke either active or latent MTrPs of the subject's low back muscles and/or elicit symptoms with manual passive movement of the spine at the joints of the low back. Exclusion criteria will also consist of the presence of any red flags revealed in the patient history (i.e., tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, prior lumbar surgery, current pregnancy, etc.) or examination (i.e. signs consistent with significant nerve root compression). Subjects will be excluded if they demonstrate signs of Chronic Regional Pain Syndrome (CRPS), are currently seeking litigation, are unable to speak English, and/or have been diagnosed with a condition that can cause prolonged MTrPs such as fibromyalgia, hypothyroidism, or iron deficiency. In addition, no patients who have a transmittable blood disease will be included.

研究组 & 干预措施

Dry Needling

Experimental

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive dry needling, patient education, and a home exercise program.

干预措施: Dry needling (Other)

Dry Needling

Experimental

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive dry needling, patient education, and a home exercise program.

干预措施: Home Exercise Program (Other)

Manual Therapy

Experimental

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive manual therapy, patient education, and a home exercise program.

干预措施: Manual therapy (Other)

Manual Therapy

Experimental

A total of 30 subjects will be randomized to this experimental arm. If randomized to this arm, subjects will receive manual therapy, patient education, and a home exercise program.

干预措施: Home Exercise Program (Other)

结局指标

主要结局

Oswestry Disability Index (change over time)

时间窗: The ODI will be recorded at baseline, 1 week, 2 weeks, and discharge/3 weeks.

The ODI is a ten question self report measure that assesses the impact of the patient's pain on their ability to perform everyday activities and is currently considered the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain.

次要结局

  • Numerical Pain Rating Scale (change over time)(The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.)
  • Patient Specific Functional Scale Score(PSFS score collected at baseline, 1 week, 2 weeks, and 3 weeks or discharge)
  • Pain pressure threshold (change over time)(The NPRS will be recorded at baseline, immediately following treatment, at 1 week, 2 weeks, and discharge/3 weeks.)
  • Percentage of recovery (one time assessment at the end of the 3 weeks)(3 weeks or Discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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