Clinical trial NCT02836626: Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain
Official title: Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section
Cicatrix
Tissue Adhesions
Lead sponsor: Rocky Mountain University of Health Professions
Sponsor class: OTHER
Collaborators: name: Franklin Pierce University
name: Section on Women's Health American Physical Therapy Association
First posted: 2016-07-19
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Age \<18
* no pain with pressure and mobility is symmetrical in all directions on initial examination.

Primary outcomes:
measure: Digital Pressure Algometer
timeFrame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
measure: Adheremeter
timeFrame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary outcomes:
measure: Global Rating of Change
timeFrame: Change from 4 weeks to 8 weeks to 16 weeks
measure: Goniometery hip extension and shoulder flexion
timeFrame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
measure: Qualitative Assessment
timeFrame: change between 4 and 8 weeks during interventions
measure: Numeric Pain Rating Scale
timeFrame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
measure: Oswestry Disability Index
timeFrame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Other outcomes:
Locations:
city: Manchester
country: United States
facility: Franklin Pierce University
state: New Hampshire
city: McLean
country: United States
facility: ITR Physical Therapy
state: Virginia
city: Lynnwood
country: United States
facility: Experience Momentum
state: Washington
Study officials:
References: