COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Franklin Pierce University
Section on Women's Health American Physical Therapy Association
Information provided by (Responsible Party):
Jennifer B. Wasserman, Rocky Mountain University of Health Professions

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Cicatrix Tissue Adhesions Procedure: deep fascial mobilization Procedure: superficial fascial mobilization Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. Goniometery hip extension and shoulder flexion [ Time Frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks ]
  3. 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

  4. 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

  5. Oswestry Disability Index [ Time Frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks ]
    Functional Index- patient survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836626


Locations
Layout table for location information
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
Experience Momentum
Lynnwood, Washington, United States, 98036
Sponsors and Collaborators
Rocky Mountain University of Health Professions
Franklin Pierce University
Section on Women's Health American Physical Therapy Association
Layout table for additonal information
Responsible Party: Jennifer B. Wasserman, Assistant Professor, PhD candidate, Rocky Mountain University of Health Professions
ClinicalTrials.gov Identifier: NCT02836626    
Other Study ID Numbers: 160448-02
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes