Acupuncture for Medial Tibial Stress Syndrome in the Primary Care Setting: 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
- 81
- 试验地点
- 1
- 主要终点
- Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11)
研究概览
简要总结
The investigators want to investigate whether the KB2 acupuncture protocol is an effective method for decreasing pain and improving physical function in adult subjects with medial tibial stress syndrome. The investigators hypothesize that there will be significant improvement in both the acute and long-term timeframes, with respect to measures of pain and function. The investigators will measure shin pain immediately prior to treatment (baseline), immediately after initial treatment, one-, two-, and four-weeks following treatment, then again at three months post-treatment. Functional status will be evaluated at the above intervals using the Pain Disability Index. The Medial Tibial Stress Syndrome (MTSS) Score is a newly developed scoring system for subject-reported outcomes in evaluating treatment of MTSS, and this will be used to evaluate pain relief and physical functional status at initial treatment (baseline) and again at the four-week follow-up. If at the four-week follow-up no significant improvement is noted, subjects in the non-acupuncture treatment group will be given the option to crossover to another KB2 acupuncture treatment regimen, with follow-up as previously noted.
详细描述
All of the below items are research-related unless marked as 'standard of care':
Screening Visit:
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Obtain and document signed Informed Consent document and HIPAA Authorization.
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Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria including previous encounter, vital signs review, medication list, co-morbidities, demographics, and problems list.
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Record: Date of birth, age, gender, race, ethnicity, DOD ID#, name of standard of care medications (over-the-counter and prescription), current email address (to be used for scheduling), height (in inches), weight (in pounds), tobacco-use status, duration of current shin splints, history of shin splints, and note any prior acupuncture received.
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Investigators will ask what the subjects expectations are regarding acupuncture's effectiveness for medial tibial stress syndrome.
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If the subject is an active duty member, investigators will ask:
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Have you or are you currently on a fitness restriction for medial tibial stress syndrome.
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If so, what are the dates of the restriction?
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There are several standard of care treatments and physical therapy options for the treatment of medial tibial stress syndrome which include physical therapy and a home exercise program. Investigators will standardize what patients in this study are receiving by having all subjects follow the standard of care prescribed home exercise program and discontinue any formal physical therapy when entering this study (regular physical activity such as exercise is allowed, as tolerated by pain level).
Randomization: Subjects will be randomized into 1 of 2 equal groups, using a random number generator:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •***THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.***
- •Inclusion Criteria:
- •Male and female DoD beneficiaries, age 18 years or older,
- •Diagnosed with medial tibial stress syndrome (in one or both of their lower extremities) OR subjects meeting criteria of pain in the posteromedial tibia with exercise and direct palpation of the posteromedial tibia. Subjects with acute and chronic diagnoses will be included.
排除标准
- •Any of the following in the lower extremity being included into the study:
- •Active cellulitis of lower extremity
- •Tibial stress fracture
- •If they have ever had any prior acupuncture for medial tibial stress syndrome using the defined KB-2 points.
- •Use of anticoagulants
- •Neurologic deficits, to include abnormal sensation, hypo- or hyper-active reflexes, muscle weakness not attributable to pain
- •History of needle-shock with acupuncture
研究组 & 干预措施
Home Exercise Only
The prescribed home exercise program alone
干预措施: Home Exercise Program (Other)
Acupuncture and Home Exercise
Acupuncture plus the prescribed home exercise program
干预措施: Acupuncture (Other)
Acupuncture and Home Exercise
Acupuncture plus the prescribed home exercise program
干预措施: Home Exercise Program (Other)
结局指标
主要结局
Change in pain over time as measured by 11-point numerical pain rating score (NPRS-11)
时间窗: Visit 1 (Day 1) Beginning, Visit 1 (Day 1) End, Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)
The NPRS is a validated segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion.
Change in pain over time as measured by Pain Disability Index (PDI)
时间窗: Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12)
The PDI score is a measure of functional status incorporating the dimensions of family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life support activities. The total of these dimensions provides the PDI score, which has been studied as clinically significant when a decrease of 9 points was observed. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which you would normally be involved have been totally disrupted or prevented by the patient's pain.
次要结局
- Change in Medial Tibial Stress Syndrome (MTSS) Score over time(Visit 1 (Day 1) , Visit 2 (Week 2), Visit 3 (Week 4), Visit 4 (Week 12))