Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

Cesarean Section Clinical Trial

Official title:

Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02836626
• Other study ID #: 160448-02
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2016
• Last updated: April 10, 2017
• Start date: June 2016
• Est. completion date: August 2017

Study information

• Verified date: April 2017
• Source: Rocky Mountain University of Health Professions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Cicatrix
• Tissue Adhesions

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Experience Momentum	Lynnwood	Washington
United States	Franklin Pierce University	Manchester	New Hampshire
United States	ITR Physical Therapy	McLean	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Rocky Mountain University of Health Professions	Franklin Pierce University, Section on Women's Health American Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Primary	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	Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary	Global Rating of Change	patient survey -7= very much worse; 0 = no change; +7= very much better	Change from 4 weeks to 8 weeks to 16 weeks
Secondary	Goniometery hip extension and shoulder flexion		Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary	Qualitative Assessment	subject comments as to response to interventions will be recorded for qualitative assessment	change between 4 and 8 weeks during interventions
Secondary	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	Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary	Oswestry Disability Index	Functional Index- patient survey	Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks