Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Time to Recovery as Measured in Months
研究概览
简要总结
The goal of this clinical trial is to learn if Osteopathic Manipulative Treatment (OMT) is an effective addition to treatment of adhesive capsulitis. OMT is a non-invasive treatment in which a doctor gently moves and stretches muscles, joints, and tissues manually. Adhesive capsulitis is more commonly known as "frozen shoulder" and describes a shoulder that becomes stiff, painful, and limited in its motion due to some structural change in the joint. The main questions it aims to answer are:
Is recovery faster when OMT is added to regular treatment? Are patients that underwent OMT more satisfied with their treatment?
Researchers will compare patients who underwent OMT to patients who did not to see if OMT is an effective additional treatment for frozen shoulder.
Participants will:
- Be assigned to one of the four experimental groups
- Visit clinic and/or physical therapy to undergo the treatments associated with their group:
- standard course of prescribed physical therapy
- standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder
- standard course of prescribed physical therapy and (up to) 4 OMT sessions
- standard course of prescribed physical therapy, an injection of an anti-inflammatory and anesthetics in the shoulder, and (up to) 4 OMT sessions.
- Visit clinic 1 month, 3 months, 6 months, and 1 year after treatment is complete
- Complete a survey about how satisfied they are with their treatment 1 month, 3 months, 6 months, and 1 year after it is complete
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with adhesive capsulitis who have not received prior treatment for it
排除标准
- •patients with contraindications to corticosteroid injections (uncontrolled diabetes, active infection, bleeding disorders, or corticosteroid hypersensitivity)
- •patients diagnosed with adhesive capsulitis who have received (or are currently receiving) treatment for it
研究组 & 干预措施
PT only
Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy
PT and OMT
Patients in this group will receive (up to) 4 sessions of OMT spaced at least 2 weeks apart in addition to the standard prescription for physical therapy
干预措施: Osteopathic Manipulative Therapy (OMT) (Other)
PT, Injection, and OMT
Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) and (up to) 4 sessions of OMT in addition to the standard prescription for physical therapy
干预措施: Osteopathic Manipulative Therapy (OMT) (Other)
PT and Injection
Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) in addition to the standard prescription for physical therapy
干预措施: Intra-articular Injection (Drug)
PT, Injection, and OMT
Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) and (up to) 4 sessions of OMT in addition to the standard prescription for physical therapy
干预措施: Intra-articular Injection (Drug)
结局指标
主要结局
Time to Recovery as Measured in Months
时间窗: Up to 12 months
The number of months separating the initial visit and the final treatment visit. The time taken for the provider to deem further treatment unnecessary
次要结局
- Change in Range of Motion of the Shoulder Relative to Baseline(Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended)
- Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM)(Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment.)
- Change in Pain as Measured by Patient-Reported Pain Score(Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.)
研究者
Kevin Killian
Principal Investigator
University Hospitals Cleveland Medical Center