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Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

Primary Purpose

Cesarean Section, Cicatrix, Tissue Adhesions

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
deep fascial mobilization
superficial fascial mobilization
Sponsored by
Rocky Mountain University of Health Professions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Section

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Franklin Pierce University
  • ITR Physical Therapy
  • Experience Momentum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Deep Fascial Mobilization

Superficial Fascial Mobilization

Arm Description

Outcomes

Primary Outcome Measures

Digital Pressure Algometer
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
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

Global Rating of Change
patient survey -7= very much worse; 0 = no change; +7= very much better
Goniometery hip extension and shoulder flexion
Qualitative Assessment
subject comments as to response to interventions will be recorded for qualitative assessment
Numeric Pain Rating Scale
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
Functional Index- patient survey

Full Information

First Posted
June 24, 2016
Last Updated
April 10, 2017
Sponsor
Rocky Mountain University of Health Professions
Collaborators
Franklin Pierce University, Section on Women's Health American Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT02836626
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rocky Mountain University of Health Professions
Collaborators
Franklin Pierce University, Section on Women's Health American Physical Therapy Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Cicatrix, Tissue Adhesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deep Fascial Mobilization
Arm Type
Experimental
Arm Title
Superficial Fascial Mobilization
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
deep fascial mobilization
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
superficial fascial mobilization
Intervention Description
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 Measure Information:
Title
Digital Pressure Algometer
Description
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
Time Frame
Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Title
Adheremeter
Description
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
Time Frame
Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary Outcome Measure Information:
Title
Global Rating of Change
Description
patient survey -7= very much worse; 0 = no change; +7= very much better
Time Frame
Change from 4 weeks to 8 weeks to 16 weeks
Title
Goniometery hip extension and shoulder flexion
Time Frame
Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Title
Qualitative Assessment
Description
subject comments as to response to interventions will be recorded for qualitative assessment
Time Frame
change between 4 and 8 weeks during interventions
Title
Numeric Pain Rating Scale
Description
Subjects are asked to rate their pain in the past 48 hours and their current pain. Pain 0= no pain, 10= maximal pain
Time Frame
Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Title
Oswestry Disability Index
Description
Functional Index- patient survey
Time Frame
Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Franklin Pierce University
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03101
Country
United States
Facility Name
ITR Physical Therapy
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States
Facility Name
Experience Momentum
City
Lynnwood
State/Province
Washington
ZIP/Postal Code
98036
Country
United States

12. IPD Sharing Statement

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Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

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