跳至主要内容
临床试验/NCT02587559
NCT02587559撤回不适用

Effectiveness of Manual Therapy and Exercise in the Management of Glenohumeral Osteoarthritis: A Randomized Controlled Trial

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家开始时间: 2016年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Functional Level Change

研究概览

简要总结

Approximately 60 subjects from a sample of convenience diagnosed with shoulder arthritis will be randomized into a two groups. The control group will receive usual medical advice and the experimental group will be referred to physical therapy for eight visits over 4-week period of time. At one month, two months, and one year the pain, function, and patient satisfaction will be compared between the two groups.

详细描述

This study will be a pragmatic, prospective, single blind, randomized controlled trial. Stratified randomization will be performed to account for those patients that necessitate a subacromial corticosteroid injection prior to or during the physical therapy intervention. The diagnosis of primary glenohumeral osteoarthritis will be confirmed by the orthopedic surgeon involved in the study. All subjects will have radiographs at the time of initial evaluation (standard medical practice) and magnetic resonance imaging will only be required at the discretion of the orthopedic surgeon when this modality is necessary to rule out other shoulder pathologies of concern.

This study will use a convenient sample of consecutive subjects who meet all inclusion criteria and present to the shoulder service physicians at UT Southwestern outpatient clinic with a primary compliant of shoulder pain and stiffness. If appropriate for the study, the subjects will be referred to physical therapy for additional assessment and care. If interested in participation, each potential subject will be educated regarding the purpose and logistics of the study and asked to enroll via informed consent.

Approximately 25 of the 50 subjects will be seen in the clinic for 6 visits within a 4 week time frame. All subjects will return for follow-up or phone call at 4, 8, and 52 weeks for final data collection and outcomes assessment. The last follow-up assessment at one year will be via phone contact. For those attending physical therapy, the duration of the visits, 1-6, will last from 30-60 min. The final visit, visit 9, will take 15-30 minutes. The phone call on the tenth interaction will last 5-10 minutes.

Session 1: Participant Enrollment - Obtainment of consent, HIPPA and health screen. Baseline dependent variable data will be collection and the subjects will be randomly allocated to one of the treatment groups. One group will receive usual medical advice including tips on posture, activity modifications, and symptom control. The other group will initiate the program of physical therapy outlined below. Subjects allocated to the physical therapy treatment arm will proceed to a standard physical therapy visit in which they will be instructed in the initial exercise training and educated on the use exercise log for assessment of compliance.

Session 2-6 (within 4 weeks after session 1): All patients in the experimental group will receive standardized physical therapy intervention to treat shoulder osteoarthritis including manual therapy (no more than 2 units, <37 minutes) and standard flexibility and range of motion exercises. Patient's will also undergo an in clinic assessment of compliance of their exercise program and appropriate progression of the shoulder strengthening exercises will be provided. Patients in the control group will not participate in sessions 2-5.

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 (Investigator)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • over 50 years of age
  • Osteoarthritis > Grade 3 on the Kellgren-Lawrence scale
  • Presence of at least two of the following findings:
  • morning stiffness that resolves within 60 minutes
  • pain > 3/10 on a numerical pain rating scale
  • asymmetrical mobility in either contralateral elevation and/or glenohumeral rotation, or notable crepitus with active motion.

排除标准

  • medical co-morbidities (diabetes and rheumatoid arthritis)
  • adhesive capsulitis
  • fractures
  • scapulothoracic paresis
  • surgery in past year
  • inability to speak English language

研究组 & 干预措施

Control

No Intervention

usual medical advice regarding symptomatic control and activity modification

Experimental

Experimental

Six visits of physical therapy to provide manual therapy and therapeutic exercise

干预措施: physical therapy (Procedure)

结局指标

主要结局

Functional Level Change

时间窗: change in function from baseline to two months

self-report outcome score via American Shoulder Elbow Surgeon's scale and Simple Shoulder Test

次要结局

  • Global Rating of Change(change in rating from baseline to two months)
  • Pittsburgh Sleep Quality Index(change in sleep quality from baseline to two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验