Cesarean SectionNCT02836626
Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain
A study testing deep fascial mobilization and superficial fascial mobilization in people with Cesarean Section and Cicatrix, run by Rocky Mountain University of Health Professions at 3 sites in United States.
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 . Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cesarean Section, Cicatrix, Tissue Adhesions
- What is being tested?
- deep fascial mobilization and superficial fascial mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Experience Momentum
Lynnwood, Washington, 98036
Franklin Pierce University
Manchester, New Hampshire, 03101
ITR Physical Therapy
McLean, Virginia, 22101
About this study
Official title: Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Cesarean Section, Cicatrix, Tissue Adhesions
- Being tested
- deep fascial mobilization, superficial fascial mobilization
- Medical subject headings
- Cicatrix, Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep fascial mobilizationProcedure or surgery
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 mobilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Fascial Mobilization | Experimental | Not described Receives: Procedure: deep fascial mobilization |
| Superficial Fascial Mobilization | Experimental | Not described Receives: Procedure: superficial fascial mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Secondary outcomes (5)
Global Rating of Change
patient survey -7= very much worse; 0 = no change; +7= very much better
Measured: Change from 4 weeks to 8 weeks to 16 weeks
Goniometery hip extension and shoulder flexion
Measured: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Qualitative Assessment
subject comments as to response to interventions will be recorded for qualitative assessment
Measured: change between 4 and 8 weeks during interventions
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
Measured: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Oswestry Disability Index
Functional Index- patient survey
Measured: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rocky Mountain University of Health Professions
- Sponsor type
- University, hospital or other
- Collaborators
- Franklin Pierce University, Section on Women's Health American Physical Therapy Association
- Responsible party
- Principal investigator, Jennifer B. Wasserman, Rocky Mountain University of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836626
- Sponsor's protocol ID
- 160448-02
- Status last verified
- Apr 2017
- First submitted
- 24 Jun 2016
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascial Scar Mobilization Techniques in Treating Chronic Caesarian Section Scar Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02836626
- Acronym / sponsor ID
- 160448-02
- Conditions
- Cesarean Section, Cicatrix, Tissue Adhesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Rocky Mountain University of Health ProfessionsUniversity, hospital or other
- Collaborators
- Franklin Pierce University, Section on Women's Health American Physical Therapy Association
- Study start
- Jun 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep Fascial Mobilization | Experimental | Procedure: deep fascial mobilization |
| Superficial Fascial Mobilization | Experimental | Procedure: superficial fascial mobilization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep fascial mobilizationPelvic 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. | Procedure or surgery | Deep Fascial Mobilization |
| superficial fascial mobilizationThis 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. | Procedure or surgery | Superficial Fascial Mobilization |
Primary outcome
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
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
5 secondary outcomes
Global Rating of Change
Time frame: Change from 4 weeks to 8 weeks to 16 weeks
Goniometery hip extension and shoulder flexion
Time frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Qualitative Assessment
Time frame: change between 4 and 8 weeks during interventions
Numeric Pain Rating Scale
Time frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Oswestry Disability Index
Time frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep fascial mobilization and superficial fascial mobilization in people with Cesarean Section and Cicatrix, run by Rocky Mountain University of Health Professions at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Pressure Algometer (time frame: Change from 0 weeks to 4 weeks to 8 weeks to 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.