Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain

NCT02836626 | Unknown DMC

• 1 other identifier: 160448-02
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Cesarean Section; Cicatrix; Tissue Adhesions

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Global Rating of Change

  Change from 4 weeks to 8 weeks to 16 weeks

• Goniometery hip extension and shoulder flexion

  Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks

• Qualitative Assessment

  change between 4 and 8 weeks during interventions

• Numeric Pain Rating Scale

  Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks

• Oswestry Disability Index

  Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks

Study Arms (2)

Deep Fascial Mobilization

EXPERIMENTAL

Procedure: deep fascial mobilization

Superficial Fascial Mobilization

EXPERIMENTAL

Procedure: superficial fascial mobilization

Interventions

deep fascial mobilization PROCEDURE

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.

Deep Fascial Mobilization

superficial fascial mobilization PROCEDURE

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.

Superficial Fascial Mobilization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rocky Mountain University of Health Professions: lead
• Franklin Pierce University: collaborator
• Section on Women's Health American Physical Therapy Association: collaborator

Study Sites (3)

Franklin Pierce University

Manchester, New Hampshire, 03101, United States

Location

ITR Physical Therapy

McLean, Virginia, 22101, United States

Location

Experience Momentum

Lynnwood, Washington, 98036, United States

Location

MeSH Terms

Conditions

Cicatrix; Tissue Adhesions

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD candidate

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 19, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (3)