Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain
|ClinicalTrials.gov Identifier: NCT02836626|
Recruitment Status : Unknown
Verified April 2017 by Jennifer B. Wasserman, Rocky Mountain University of Health Professions.
Recruitment status was: Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : April 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section Cicatrix Tissue Adhesions||Procedure: deep fascial mobilization Procedure: superficial fascial mobilization||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||August 2017|
|Experimental: Deep Fascial Mobilization||
Procedure: deep fascial mobilization
Pelvic and abdominal myofascial release techniques as described by Barnes will be performed to facilitate independent mobility between tissue layers as needed following the direction of palpated fascial tension. Following this, direct scar mobilization techniques as described by Manheim will be done, applying a stretch in the direction of palpated restriction . This involves applying deep pressure whose force and direction is dictated by the tightness the therapist palpates and the subject reports. These are each held until a release is felt (defined as a sudden relaxation of tissue tension), usually 60-120 seconds. Total treatment time will last 25 minutes. Treatments will include all the above techniques but the therapist will tailor each treatment to address palpated restrictions. Subjects will be instructed to carry on their normal routines between sessions and will not be given any home interventions. Treatment sessions will total four to occur within a three week time period.
|Experimental: Superficial Fascial Mobilization||
Procedure: superficial fascial mobilization
This group will undergo four 25-minute sessions of gentle superficial effleurage to the abdomen and posterior trunk followed by superficial skin rolling to the scar. Each treatment session will be terminated a) after 25 minutes or 2) when the patient asks to stop due to discomfort. Reasons for termination will be documented. Subjects will be instructed to carry on their normal routines between sessions and will not be given any home interventions. Treatment sessions will total four to occur within a three week time period.
- Digital Pressure Algometer [ Time Frame: 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 [ Time Frame: 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
- Global Rating of Change [ Time Frame: Change from 4 weeks to 8 weeks to 16 weeks ]patient survey -7= very much worse; 0 = no change; +7= very much better
- Goniometery hip extension and shoulder flexion [ Time Frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks ]
- Qualitative Assessment [ Time Frame: change between 4 and 8 weeks during interventions ]subject comments as to response to interventions will be recorded for qualitative assessment
- Numeric Pain Rating Scale [ Time Frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks ]Subjects are asked to rate their pain in the past 48 hours and their current pain. Pain 0= no pain, 10= maximal pain
- Oswestry Disability Index [ Time Frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks ]Functional Index- patient survey
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836626
|United States, New Hampshire|
|Franklin Pierce University|
|Manchester, New Hampshire, United States, 03101|
|United States, Virginia|
|ITR Physical Therapy|
|McLean, Virginia, United States, 22101|
|United States, Washington|
|Lynnwood, Washington, United States, 98036|