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Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

R

Rocky Mountain University of Health Professions

Status

Unknown

Conditions

Tissue Adhesions
Cicatrix
Cesarean Section

Treatments

Procedure: superficial fascial mobilization
Procedure: deep fascial mobilization

Study type

Interventional

Funder types

Other

Identifiers

NCT02836626
160448-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

29 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

29 participants in 2 patient groups

Deep Fascial Mobilization
Experimental group
Treatment:
Procedure: deep fascial mobilization
Superficial Fascial Mobilization
Experimental group
Treatment:
Procedure: superficial fascial mobilization

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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