Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Digital Pressure Algometer
研究概览
简要总结
Over 1.37 million Caesarian sections (C-sections) are performed annually in the US . It is estimated that 12-20 % of those will result in chronic scar pain. This pain can lead to functional difficulties performing activities of daily living, pain with bowel movements, and pain with sexual activity . There is anecdotal evidence supporting the use of deep fascial scar mobilization techniques in reducing abdominal surgical scar pain, and yet almost no research has been published. The aims of this randomized clinical trial will be to determine if deep fascial scar mobilization techniques or superficial scar mobilization techniques will improve chronic pain and its resulting functional deficits, threshold pressure discomfort, pressure tolerance and mobility restrictions resulting from C-section surgery and to see if these interventions are more effective than no intervention. A positive result may result in an increase in the use of this intervention and thus the reduction of chronic scar pain for many women; it may provide justification for insurance reimbursement for this approach and it will also pave the way for further investigation into the use of these techniques with other types of painful scars including hysterectomy.
详细描述
Methods: Thirty six subjects will be recruited who have a history of C-section surgery more than three months before entering the study and who report chronic pain in or around the scar stemming from the surgery. Subjects will initially be tested twice four weeks apart, before beginning intervention. This will allow the establishment of a baseline and the subjects will all be part of a baseline control group. They will then be randomly assigned to one of two treatment groups. Group 1 will undergo four, 25 minute sessions of light massage to the trunk followed by superficial skin rolling of the C-section scar. Group 2 will undergo four, 25-minute treatment sessions consisting of multi-planar pelvic and abdominal myofascial mobilization techniques and direct scar mobilization techniques..
Outcomes: Outcome measures will include threshold pressure discomfort and pressure tolerance using a Pressure Algometer, Adheremeter measurements of scar mobility, the numeric pain rating scale (NPRS), the Oswestry Disability Index (ODI), Hip extension and shoulder flexion measured via goniometery, and the Global rating of Change scale. Follow up measures will be collected four weeks following the start of interventions and again at 12 weeks. In addition qualitative data will be collected from the subjects. The treating therapist will be blinded to the results of the outcome measures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •well- healed abdominal scar over 3 months old that is resulting in chronic pain
- •pain can be intermittent, at rest or with activity, and must have been present at least at a 3/10 at some point in the month prior to evaluation
- •patient must report the presence of chronic pain.
排除标准
- •history of cancer in pelvis or abdomen
- •active infection / infectious disease in pelvis or abdomen
- •pain medications on days of measurements
- •skin irritation/inflammation at site of scar
- •currently pregnant
- •history of radiation to area
- •no pain with pressure and mobility is symmetrical in all directions on initial examination.
结局指标
主要结局
Digital Pressure Algometer
时间窗: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
6 points along the scar will be assessed. Pressure Pain threshold is the force (N) at which pressure turns to pain and Pressure Pain tolerance is the force (N) at which the pain becomes intolerable
Adheremeter
时间窗: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
6 points along the scar will be assessed. Scar flexibility (mm) in each of 4 directions (superior, right, left, inferior) will be assessed at each point
次要结局
- Qualitative Assessment(change between 4 and 8 weeks during interventions)
- Goniometery hip extension and shoulder flexion(Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks)
- Global Rating of Change(Change from 4 weeks to 8 weeks to 16 weeks)
- Numeric Pain Rating Scale(Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks)
- Oswestry Disability Index(Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks)
研究者
Jennifer B. Wasserman
Assistant Professor, PhD candidate
Rocky Mountain University of Health Professions