The Reproducibility and Consistency of Instrument-assisted Soft Tissue Manipulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Phase I Stroke Pattern Characteristic Descriptions
研究概览
简要总结
The overall purpose of this study is to objectively describe and test the consistency and reproducibility of instrument-assisted soft tissue manipulation (IASTM).The specific aims of this current study are to:
- Analyze IASTM stroke patterns using objective metrics;
- Test the consistency of force application, with and without visual monitoring of objective metrics, and;
- Determine the reliability of dynamic pressure pain threshold assessment. The ultimate goal of this continuing line of research is to improve soft tissue manual therapy practice in research, education, and clinic for use as a non-invasive modality in soft tissue assessment and treatment. Results from this protocol will inform future clinical trials, including studies exploring the effects of different IASTM dose-loads in various musculoskeletal pain conditions.
详细描述
This is a single-site study consisting of three study phases. Phase I will observe and analyze clinician's application of instrument-assisted soft tissue manipulation (IASTM) as a means to identify signature profiles for the stroke rate, angle, and direction that are characteristic of basic (e.g., linear, curved) stroke patterns. Phase II will assess the consistency of IASTM force application. Phase III will assess the reliability of dynamic pressure pain threshold assessment. Clinician participants (Phase I) will attend one study visit consisting of basic linear and curved IASTM stroke pattern applications and complete a questionnaire. Total study duration for clinician participants will be 90 minutes. Non-clinician subjects will attend two study visits (Phase II) or one study visit (Phase III). Visits will consist of completion of questionnaires, application of IASTM strokes by a clinician using the QSTM device, and stretching.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18-75 years old.
- •Be a licensed, practicing healthcare clinician (e.g. physical therapist, massage therapist, osteopathic physician, athletic trainer, chiropractor)
- •Have at least 8 years of clinical experience in instrument-assisted soft tissue manual therapy
- •Male and female subjects between 18-75 years old
- •Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2
- •Male and female subjects, ages younger (≥18 but ≤30yo) and older (≥50 but ≤75yo)
- •Body Mass Index (BMI) ≥ 18.5 kg/m2 but <30 kg/m2
排除标准
- •<8 years of clinical experience in instrument-assisted soft tissue manual therapy practice
- •Any known pain conditions, such as nerve impingement (radiculopathies), rheumatoid arthritis, osteoarthritis, or any other inflammatory conditions that could interfere with the participant's ability to perform basic IASTM stroke patterns.
- •Any known cardiovascular, pulmonary, or metabolic disease that could interfere with the clinician's ability to perform basic IASTM stroke patterns.
- •Known cardiovascular, pulmonary, or metabolic disease;
- •Current smoking or those who quit smoking within the previous 6 months;
- •Current use of anti-inflammatory or analgesics;
- •Any history of back, neck, lower extremity, or abdominal surgery or injury; or back, neck, or leg pain within the previous 6 months that impaired function;
- •Any co-morbidities that could contribute to back, neck, or leg pain (e.g., radiculopathies, rheumatoid arthritis, osteoarthritis, inflammatory conditions).
- •The same exclusion criteria as for Phase II.
结局指标
主要结局
Phase I Stroke Pattern Characteristic Descriptions
时间窗: Analysis results within 6 months.
The objectives metrics from quantifiable soft tissue manipulation device system will be analyzed for common or characteristic applications between clinicians.
Phase III Reliability of Dynamic Pressure Pain Threshold Assessment
时间窗: Measured within 2 hours on same day of testing. Results reported by end of study at one year.
The agreement between and within clinicians in pressure pain threshold assessment over a body area will be determined within a single session.
Phase II Reliability of IASTM Force Application
时间窗: Measured within 2 hours for same day reliability and at 7 days for between day reliability. Results reported by end of study at one year
The agreement in soft tissue manipulation force application, between and within clinicians, will be determined within a single session and between session (within 7 days apart).
次要结局
- (Phase III Only) Strength(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Vertical Jump Test(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Blood Pressure(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Hamstring Length Flexibility Test.(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Trunk Forward Bend Flexibility Test.(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Static Pressure Pain Threshold(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Range of Motion(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Heart Rate(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) Skin Surface Temperature(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
- (Phase III Only) 10-Meter Walk Test (10-MWT)(Measured before and within 2 hours after IASTM force application. Results reported by end of study at one year.)
研究者
Mary T. Loghmani
Associate Professor
Indiana University