Pain Reduction in Tibial Stress Syndrome Using Compression Garments
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in reported pain scores using compression garments
研究概览
简要总结
This study is intended to determine if compression garments effectively reduce pain in the treatment of tibial stress syndrome (TSS) in the military population. The study will include diagnoses of shin splints, which is medically known as tibial stress syndrome and medial tibial stress syndrome, and compare a treatment group using compression garments to a control group using passive recovery. Both groups will engage in a progressive walk-to-run program. The outcomes will be measured by comparison in pain scales pre and post treatments. The ability to perform a two mile run without pain symptoms will be assessed at the conclusion of the study by participant's self-reported evaluation. The TSS screening questionnaire will be obtained at each medical encounter to include the initial visit and follow-up visits at the four and eight week (+/- 3 days) marks. The self-reported 2-mile run evaluation is included on the TSSS questionnaire.
详细描述
The study objective is to determine whether use of compression garments in the treatment of tibial stress syndrome will reduce pain compared with passive recovery alone.
Specific aims include evaluation of Visual Analog Scale (VAS) when utilizing compression garments and passive recovery and a self-reported pain free running assessment by the participant. VAS evaluation will occur at initial encounter, four weeks from treatment initiation, and then again at eight weeks from treatment start. The follow up time frames will have a ± three days to allow flexibility of the participant to follow up. The study will be assessed with a 60 day evaluation period to coincide with previous study time periods as well as the ability to lessen the possibility of participants lost to follow up that may be relocated due to military orders. Assessment of functionality, symptomatic criteria, and determination if further care is required will occur at each visit. A self-reported pain free running assessment will be collected via questionnaire at the conclusion of the study.
The investigators intend to prove that compression garments will better reduce pain symptoms in the treatment of tibial stress syndrome (shin splints) compared with passive recovery alone.
Conduct a prospective randomized control trial with the objective of determining if the application of compression garments for the symptomatic treatment of tibial stress syndrome produces improved rates of pain relief and activity tolerance compared to the control of passive recovery.
Subject population will be gathered from Fort Sam Houston McWethy TMC patients who consist of active duty trainees for all military branches of service. Male and female participants from 18-45 years of age presenting with leg pain consistent with tibial stress syndrome will be considered for this study. Age limitation is based on assumed increase in potential confounders related to previous injury or pre-existing musculoskeletal conditions. Approximately 42 participants are required based on comparison with previous studies. This includes a 20 percent addition to account for participants lost to follow-up. Control group will be treated with passive recovery only.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of the McWethy TMC
- •Able to provide informed consent (of sound mind)
- •Acute or acute on chronic musculoskeletal pain of lower extremity
- •18-45 years of age
- •Active duty military trainees of all service branches assigned to unit on Ft Sam Houston
- •Pain at presentation indicated on Visual Analog Scale (VAS). All scores indicated on the VAS will be accepted
排除标准
- •Patients outside of the McWethy TMC or not assigned to a unit on Ft Sam Houston
- •Patient with lower extremity pain not consistent with tibial stress syndrome
- •Participants with open wounds of the lower extremity
- •Temperature greater than 38˚ Celsius (100.4 Fahrenheit)
- •Pain associated with current diseases (neurologic/rheumatologic/cancer)
- •Active infection at injury location
- •Patients younger than 18 or older than 45 years of age
研究组 & 干预措施
Relative Rest (Control)
Male/Female Military Trainees with symptoms consistent with Tibial Stress Syndrome. No compression. Standard of care therapy includes relative extremity rest, stretches and graduated run program.
Compression Garments
Male/Female Military Trainees with symptoms consistent with Tibial Stress Syndrome. Standard of care therapy includes compression garments worn, stretches and graduated run program.
干预措施: Pro-Tec Shin Splint Compression Wrap (Device)
结局指标
主要结局
Change in reported pain scores using compression garments
时间窗: Initial visit, 4 week follow up, 8 week follow up
scored against Visual Analog Pain Scale from 0 to 100 millimeters with 0 being no pain and 100 being the worst pain possible
次要结局
未报告次要终点
研究者
Marion V. Sanders
Principal Investigator
Brooke Army Medical Center