Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia vs Traditional Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Patient-rated tennis elbow evaluation (PRTEE)
研究概览
简要总结
The purpose of this study is to compare the clinical effectiveness and outcomes between current evidence based clinical care and use of personalized blood flow restriction training in the treatment of lateral epicondylalgia ("tennis elbow").
详细描述
Background: Lateral Epicondylalgia, or "tennis elbow", has been shown to affect up to 3% of the population and is a common musculoskeletal condition which also affects military service members. This study will compare clinical effectiveness of two treatment programs in individuals with lateral elbow pain.
Design: Prospective randomized controlled clinical trial
Methods: Participants, between the ages of 18-65, presenting to the NMCSD or NHCP Occupational or Physical Therapy Clinics with complaint of lateral elbow pain will be eligible for consideration to participate in this research. Patients that meet the inclusion criteria and elect to participate in the study will be randomized to either (1) a standardized, evidence based rehabilitation program or (2) an exercise volume matched group using personalized blood flow restriction (BFR) exercise.
Upon entry to the program subjects will complete measurements of height, body weight, physical activity level (Marx Activity Scale), annotation of their dominant upper extremity (UE), the patient-rated tennis elbow evaluation (PRTEE) questionnaire, Numerical Pain Rating Scale (NPRS), Patient-Reported Outcome Measurement Information System version 1.2- Global Health (PROMIS scale v1.2- Global Health), and grip strength using the JAMAR dynamometer. At the end of each treatment session subjects will complete the Numerical Pain Rating Scale (NPRS) and the OMNI-Resistance Exercise Scale (OMNI-RES) rating of perceived exertion (RPE) survey.
The standard rehabilitation group will perform active wrist extension, forearm supination, and gripping. These exercises may include isometric, concentric, or eccentric forms of strengthening contingent upon clinical decision making. Specifics of exercise performance (to include magnitude of resistance and volume of exercise) will be documented in the treatment record.
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
- Single (Outcomes Assessor)
盲法说明
Treating therapists and patient will be aware of treatment. Grip strength objective measure will be performed by a clinician blinded to the participant's treatment group. All other outcome measures are patient-reported on outcome forms.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lateral elbow pain (e.g. "tennis elbow" or wrist extensor tendinopathy)
- •Between the ages of 18-65
- •Elbow pain for 4 weeks or more
排除标准
- •Ligamentous elbow sprain, osteoarthritis of elbow and cervical radiculopathy in the affected limb will be excluded from the study.
- •Any history of ligamentous, bony or other soft tissue reconstruction surgery at the affected elbow.
- •Vascular disorders to include: history of DVT, history of endothelial dysfunction, peripheral vascular disease
- •Current fracture in affected arm
- •History of crush injury to affected arm
- •Any surgery on affected arm in last 1 year
- •Surgery within last year on contralateral upper extremity
- •History of lymphectomy (such as axillary exploration with breast surgery, lymph node biopsy in the affected axilla/arm)
- •Active infection
- •Current cancer diagnosis/treatment
- •Sickle cell anemia or trait
- •Kidney dialysis
- •History of syncope/passing out with pressure to body (such as massage, or blood pressure cuff).
- •Inability to consent
- •Thromboembolism
- •Varicose veins
- •Cardiovascular disorders
- •Taking anti-coagulant medications
- •Bleeding disorder
- •Instructed by a physician or medical practitioner that they are not cleared to exercise
结局指标
主要结局
Patient-rated tennis elbow evaluation (PRTEE)
时间窗: Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Change in score of the patient reported outcome measure (form): rating pain as well as difficulty on a scale of 0-10 with certain movements and functional activities. Lower numbers suggest less pain, higher scores suggest more pain. Total score 0-100.
Grip Strength
时间窗: Taken at initial intake, and at the 3-week, 6-week, 3-month, and 6-month follow-up sessions
Assessing change in grip strength using the JAMAR dynamometer- taken with elbow straight, average of 3 measurements recorded.
Numerical Pain Rating Scale
时间窗: Taken at initial intake, after completion of each treatment session (up to 12 total sessions following initial evaluation), and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions
Change in score on 0-10 pain rating scale with 0 being no pain, and 10 being worst pain
次要结局
- Patient-Reported Outcome Measurement Information System version 1.2- Global Health(Taken at initial intake, and at the 3-week, 6-week, 3-month, 6-month and 12-month followup sessions)
研究者
Tara Haugen, OTR/L, CBIS
LT, Physical Therapist
United States Naval Medical Center, San Diego