Effectiveness of Trigger Point Dry Needling and Physical Therapy Versus Physical Therapy Alone Following Shoulder Stabilization Repair: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Shoulder Flexion Passive Range of Movement (PROM)
研究概览
简要总结
The purpose of this single-blinded, randomized clinical trial is to determine the effectiveness of dry needling compared to a standard shoulder rehabilitation program on range of motion, functional movement, and pain in patients who have undergone shoulder stabilization surgery. Measurements of the aforementioned dependent variables will be taken at time intervals of four weeks, eight weeks, 12 weeks, and six months post-operatively. It is hypothesized that the inclusion of dry needling will result in an increase in range of motion, increase in functional movement, and decrease in pain at an accelerated rate when compared to rehabilitation alone.
详细描述
Methodology /Technical Approach 30-50 subjects at least four weeks after shoulder stabilization surgery will be randomized into two groups (one experimental group and one control group). Subjects in the experimental group will receive Trigger Point Dry Needling (TDN) intervention with standard rehabilitation protocol (Appendix A) while subjects in the control group will receive the same standard rehabilitation protocol without TDN. The experimental group will receive trigger point dry needling one time per week for four to six weeks in addition to the standard rehabilitation protocol. The control group will receive only the standard rehabilitation protocol. Baseline measurements will be taken at approximately four weeks post operatively, and subsequent measurements will be recorded at eight weeks, 12 weeks, and six months.
All patients who have undergone a shoulder stabilization procedure will be invited to participate. Description of the study and informed consent will take place prior to randomization. Concealed randomization will take place 0-7 days post-operatively.
At 4 weeks post-operatively, the following assessment tests will be undertaken: supine shoulder flexion, supine shoulder external rotation, supine shoulder internal rotation, functional movement testing, functional outcome measures, and the numeric pain rating scale. 1,2,3 Those subjects in the 'experimental group' will receive manual palpation of all upper quarter muscles, including the cervical and thoracic spine region, to detect the presence of myofascial trigger points (TPs). Dry needling will be performed to all detected TPs by a provider trained and experienced in TDN.
In addition to the TDN intervention, the experimental group subjects will undergo a rehabilitation program in accordance with a shoulder stabilization repair protocol which is the standard of care for this surgical procedure. Per the shoulder stabilization protocol, subjects will be instructed in a home exercise plan (HEP) that will reinforce the clinical treatment, will be provided with a handout of instructions, and will be required to demonstrate all exercises correctly.
Subjects in the 'control group' will undergo a rehabilitation program as described above for the 'experimental group', except that they will not receive a TDN intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-40 yo DOD Beneficiaries
- •Status Post Shoulder Stabilization Repair Surgery
排除标准
- •Self-Reported Pregnancy
- •History of blood borne pathogens/infectious disease/active infection/metal allergy
- •Bleeding disorders or currently taking anti-coagulant medications
- •Participants who are not fluent in English
研究组 & 干预措施
Rehabilitation and Dry Needling
Standard Rehabilitation Protocol following shoulder stabilization surgery and Dry Needling to the Shoulder girdle 1 time a week for 4 weeks between weeks 4 and 8 post operatively
干预措施: Rehabilitation and Dry Needling (Device)
Rehabilitation
Standard Rehabilitation Protocol following shoulder stabilization surgery alone
干预措施: Rehabilitation (Device)
结局指标
主要结局
Shoulder Flexion Passive Range of Movement (PROM)
时间窗: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Subject is supine with hips and knees flexed for stabilization. Elbow will be extended, forearm relaxed, and wrist in neutral position. Subjects' arm will be raised into forward flexion by the practitioner. The stationary arm of the goniometer will be placed parallel to the spine but at the lateral aspect of the body. The moving arm of the goniometer will be placed along the midline of the humerus.
Shoulder External Rotation PROM at 8 Weeks
时间窗: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees. Elbow flexed to 90 degrees. Forearm in the midposition between supination and pronation and perpendicular to the plinth. Subject arm rotated by the practitioner. The stationary arm of the goniometer will be horizontal to the plinth with the pivot of the protractor on the olecranon process. The moving arm of the goniometer is in line with the styloid process of the ulna.
Shoulder Internal Rotation (IR) PROM
时间窗: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Subject is supine on the plinth with hips and knees flexed for stabilization. Tested arm abducted to 90 degrees, elbow flexed to 90 degrees, forearm in the midposition between supination and pronation and perpendicular to the plinth,. Subject arm internally rotated by practitioner. Stationary arm of goniometer horizontal to the plinth with the pivot of the protractor on the olecranon process. Moving arm of the goniometer in line with the styloid process of the ulna.
Numeric Pain Rating Scale (NPRS)
时间窗: at 8 weeks post-op, 12 weeks post-op, 6 months post-op
Numeric Pain Rating Scale. Numerical Scale from 1-10. Subjects are asked self-report pain on a scale from 1 - 10, 1 being the least amount of pain and 10 being the most. The Minimum Important Difference for the NPRS (on a scale from 0-10) range from -1.5 (small change) to -3.0 (medium change) to -3.5 (large change)
次要结局
- Global Rating of Change(at 8 weeks post-op, 12 weeks post-op, 6 months post-op)
- Patient Specific Functional Scale(at 8 weeks post-op, 12 weeks post-op, 6 months post-op)
- Shoulder Pain and Disability Index Functional Outcome Measure(at 8 weeks post-op, 12 weeks post-op, 6 months post-op)