ScarNCT03936309
A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section
A study testing Scar Deactivation Surface Release Technique protocol, Scar Infiltration with 0.25-1% Lidocaine and Physical therapy in people with Scar and Cesarean Section; Dehiscence, run by Jennifer Loomis at 1 site in United States.
Trial summary
To compare scar infiltration with 0.5-1% Lidocaine at a dose of 3 mg/kg (max dose 300 mg) or scar deactivation with acupuncture surface release technique to determine which is more effective in reducing pain in adult patients with chronic, post-surgical pain related to the site of incision after low transverse… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Scar, Cesarean Section; Dehiscence
- What is being tested?
- Scar Deactivation Surface Release Technique protocol, Scar Infiltration with 0.25-1% Lidocaine and Physical therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 8 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female DoD beneficiaries age 18 years or older
- 3 months or greater postpartum with abdominal and/or back pain starting after low transverse Cesarean section scar.
- If subject has had prior Scar Deactivation with Surface Release Technique for cesarean section scar they must have completed a washout period of 12 weeks or more.
Who cannot join
- Pregnant
- Prior Scar Deactivation with Surface Release Technique for cesarean section scar within the last 12 weeks.
- Ever had Prior Scar Infiltration with Lidocaine for cesarean section.
- Active cellulitis surrounding scar
- Revision of Cesarean section scar
- Vertical incision or emergent Cesarean section
Trial locations and contacts
1 site in 1 country.
United States1 site
375th Medical Group
Scott Air Force Base, Illinois, 62225
About this study
Official title: A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section in the Primary Care Setting: A Comparative Effectiveness Trial.
To compare scar infiltration with 0.5-1% Lidocaine at a dose of 3 mg/kg (max dose 300 mg) or scar deactivation with acupuncture surface release technique to determine which is more effective in reducing pain in adult patients with chronic, post-surgical pain related to the site of incision after low transverse Cesarean section compared to standard of care physical therapy with the McKenzie Method.
Read the detailed description
While there is not a clearly established and widely accepted pathophysiological cause to this post-operative pain, studies have estimated that between 7-33% of patients experience chronic peri-incisional pain after Cesarean section with Pfannenstiel incision - a type of abdominal surgical incision that allows access to the abdomen and the most common method for performing Cesarean sections today - defined as pain persisting beyond the period of expected healing, approximately 3 months.
Management of chronic peri-incisional pain after Cesarean section requires an extensive workup including laboratory testing (CBC, ESR, Urinalysis, STI testing) and imaging (transvaginal ultrasonography and abdominal CT) to rule out organic causes. Once a visceral etiology from postoperative pain has been excluded, there is not a well-established guideline dictating standard of care, however treatment can include analgesics such as Acetaminophen or Non-Steroidal Anti-inflammatory Drugs, and in refractory cases suggestive of neuropathic pain Tricyclic Antidepressants, Gabapentin, Pregabalin, and Serotonin-Norepinephrine Reuptake Inhibitors can be used. If medicinal therapy fails to manage symptoms, consultation for pain management specialists and/or surgical evaluation is often considered.
Scar deactivation is used as standard of care for treatment and resolution of scar associated pain in patients with a history of Cesarean section by medical acupuncturists, both abdominal and/or low back pain that began after the cesarean section. Scar infiltration with lidocaine has been used in numerous clinical settings, masquerading under different names. Referred to as Neural Therapy in Germany, the technique of injecting short-acting local anesthetic into the dermal subcutaneous junction of scar tissue has been widely applied; however there is limited readily available clinical trial evidence supporting its reported effectiveness. Theoretically, it is postulated that the anti-inflammatory effects of local anesthetics play a role in mitigating the autonomic nervous system disruption of interference fields caused by scar tissue. Local anesthetics promote anti-inflammatory activity through a variety of mechanisms including reversibly inhibiting leukocyte adhesion by interfering with the action of integrins and leukocyte adhesion molecule-1, limiting leukocyte migration, reversible inhibition of phagocytosis, inhibition of phospholipase A2, inhibition of prostaglandins, inhibition of thromboxane release, inhibition of leukotriene release, inhibition of histamine release, reduction in free radical formation, and inhibition of cytokine release. Additionally, Lidocaine injection is proposed to alleviate nerve entrapment within fascia through hydrodissection, a technique being effectively utilized in the management of carpal tunnel syndrome.
Scar deactivation is the technique of inserting acupuncture needles at a 30-45 degree angle into the superficial fascia to surround a scar. It is postulated that needle insertion into connective tissue produces analgesia through a multifaceted process encompassing the disruption and remodeling of extracellular matrix in loose connective tissue, alterations in gene expression affecting neurotransmitter levels, and cellular signaling pathways impacted in response to fibroblast and mast-cell involvement. In traditional Chinese medicine, injuries resulting in scar tissue formation are thought of as areas of blood and subsequently Qi stagnation. Disruptions in the flow of Qi at the point of scar tissue can result in abnormal skin sensations such as pain, itching, and numbness in addition to systemic effects. A case report has demonstrated effective pain relief in with an acupuncture protocol utilizing scar deactivation technique.
- Conditions
- Scar, Cesarean Section; Dehiscence
- Being tested
- Scar Deactivation Surface Release Technique protocol, Scar Infiltration with 0.25-1% Lidocaine, Physical therapy
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scar Deactivation Surface Release Technique protocolOther
▪ Alternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment.
Scar Infiltration with 0.25-1% LidocaineOther
▪ Will consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose.
Physical therapyOther
▪ Will be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain.
| Study group | Role | What they receive |
|---|---|---|
| Scar Deactivation Surface Release | Experimental | Alternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment. Receives: Other: Scar Deactivation Surface Release Technique protocol |
| Scar Infiltration with 0.25-1% Lidocaine | Experimental | Will consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose. Receives: Other: Scar Infiltration with 0.25-1% Lidocaine |
| Physical Therapy | Experimental | Will be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Defense and Veterans Pain Rating Scale (DVPRS) between each time frame
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used.
The goal for pain reductions will be 50% as a primary outcome.
Measured: time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks
Change in Patient and Observer Scar Assessment Scale (POSAS) between each time frame
The Patient and Observer Scar Assessment Scale consists of the total score of two numeric scales measured by the patient and a qualified observer. Each scale assesses the scar by six characteristics on 10-point scales with a 1 corresponding to normal skin and a 10 representing the worst imaginable condition for that characteristic. The Total Score of both scales is calculated by summing scores of the six items resulting in a range of 6 to 60. The POSAS is treated as an interval variable; therefore, parametric methods will be used for this outcome.
Measured: time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks
Secondary outcomes (2)
Single question asking if subjects' expectations were met? -- Binary yes/no
Ask if the subjects' expectations were met regarding physical therapies/lidocaine/acupuncture effectiveness for chronic, post-surgical pain related to low transverse Cesarean Section. Answer is Yes/No.
Measured: 20 weeeks
Single question asking subjects' change in pain severity reported as a percentile (10%, 20%, ...)
Report as a percentage, where the greater the percent the greater the pain reduction.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jun 2019
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ScarStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Loomis
- Sponsor type
- US federal agency
- Collaborators
- Mike O'Callaghan Military Hospital
- Responsible party
- Sponsor-investigator, Jennifer Loomis, 375th Medical Group, Scott Air Force Base
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936309
- Sponsor's protocol ID
- FWH20190005H
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2019
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
PubMed 28135188Wasserman JB, Steele-Thornborrow JL, Yuen JS, Halkiotis M, Riggins EM. Chronic caesarian section scar pain treated with fascial scar release techniques: A case series. J Bodyw Mov Ther. 2016 Oct;20(4):906-913. doi: 10.1016/j.jbmt.2016.02.011. Epub 2016 Mar 10.
PubMed 27814873Okabayashi K, Ashrafian H, Zacharakis E, Hasegawa H, Kitagawa Y, Athanasiou T, Darzi A. Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity. Surg Today. 2014 Mar;44(3):405-20. doi: 10.1007/s00595-013-0591-8. Epub 2013 May 9.
PubMed 23657643Suleiman S, Johnston DE. The abdominal wall: an overlooked source of pain. Am Fam Physician. 2001 Aug 1;64(3):431-8.
PubMed 11515832Srinivasan R, Greenbaum DS. Chronic abdominal wall pain: a frequently overlooked problem. Practical approach to diagnosis and management. Am J Gastroenterol. 2002 Apr;97(4):824-30. doi: 10.1111/j.1572-0241.2002.05662.x.
PubMed 12003414Loos MJ, Scheltinga MR, Mulders LG, Roumen RM. The Pfannenstiel incision as a source of chronic pain. Obstet Gynecol. 2008 Apr;111(4):839-46. doi: 10.1097/AOG.0b013e31816a4efa.
PubMed 18378742Speer LM, Mushkbar S, Erbele T. Chronic Pelvic Pain in Women. Am Fam Physician. 2016 Mar 1;93(5):380-7.
PubMed 26926975Brobyn TL, MK Chung, and PJ LaRiccia "Neural therapy: An overlooked game changer for patients suffering chronic pain?" J Pain Relief 2015;4: 184.
Weinschenk S. "Neural therapy--A review of the therapeutic use of local anesthetics" Acupuncture and Related Therapies 2012.
Egli S, Pfister M, Ludin SM, Puente de la Vega K, Busato A, Fischer L. Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients. BMC Complement Altern Med. 2015 Jun 27;15:200. doi: 10.1186/s12906-015-0735-z.
PubMed 26115657Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
PubMed 10969322Cassuto J, Sinclair R, Bonderovic M. Anti-inflammatory properties of local anesthetics and their present and potential clinical implications. Acta Anaesthesiol Scand. 2006 Mar;50(3):265-82. doi: 10.1111/j.1399-6576.2006.00936.x.
PubMed 16480459Malone, D, T Clark, and N Wei. "Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new technique." Journal of Applied Research. 2010;10(3):116-123.
Liddle CE, Harris RE. Cellular Reorganization Plays a Vital Role in Acupuncture Analgesia. Med Acupunct. 2018 Feb 1;30(1):15-20. doi: 10.1089/acu.2017.1258.
PubMed 29410716Fang S. The successful treatment of pain associated with scar tissue using acupuncture. J Acupunct Meridian Stud. 2014 Oct;7(5):262-4. doi: 10.1016/j.jams.2014.05.001. Epub 2014 Jun 24.
PubMed 25441952
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section in the Primary Care Setting: A Comparative Effectiveness Trial.
- ClinicalTrials.gov ID
- NCT03936309
- Acronym / sponsor ID
- FWH20190005H
- Conditions
- Scar, Cesarean Section; Dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jennifer LoomisUS federal agency
- Collaborators
- Mike O'Callaghan Military Hospital
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 3 May 2019 (actual)
- 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.
To compare scar infiltration with 0.5-1% Lidocaine at a dose of 3 mg/kg (max dose 300 mg) or scar deactivation with acupuncture surface release technique to determine which is more effective in reducing pain in adult patients with chronic, post-surgical pain related to the site of incision after low transverse Cesarean section compared to standard of care physical therapy with the McKenzie Method.
Detailed description
While there is not a clearly established and widely accepted pathophysiological cause to this post-operative pain, studies have estimated that between 7-33% of patients experience chronic peri-incisional pain after Cesarean section with Pfannenstiel incision - a type of abdominal surgical incision that allows access to the abdomen and the most common method for performing Cesarean sections today - defined as pain persisting beyond the period of expected healing, approximately 3 months.
Management of chronic peri-incisional pain after Cesarean section requires an extensive workup including laboratory testing (CBC, ESR, Urinalysis, STI testing) and imaging (transvaginal ultrasonography and abdominal CT) to rule out organic causes. Once a visceral etiology from postoperative pain has been excluded, there is not a well-established guideline dictating standard of care, however treatment can include analgesics such as Acetaminophen or Non-Steroidal Anti-inflammatory Drugs, and in refractory cases suggestive of neuropathic pain Tricyclic Antidepressants, Gabapentin, Pregabalin, and Serotonin-Norepinephrine Reuptake Inhibitors can be used. If medicinal therapy fails to manage symptoms, consultation for pain management specialists and/or surgical evaluation is often considered.
Scar deactivation is used as standard of care for treatment and resolution of scar associated pain in patients with a history of Cesarean section by medical acupuncturists, both abdominal and/or low back pain that began after the cesarean section. Scar infiltration with lidocaine has been used in numerous clinical settings, masquerading under different names. Referred to as Neural Therapy in Germany, the technique of injecting short-acting local anesthetic into the dermal subcutaneous junction of scar tissue has been widely applied; however there is limited readily available clinical trial evidence supporting its reported effectiveness. Theoretically, it is postulated that the anti-inflammatory effects of local anesthetics play a role in mitigating the autonomic nervous system disruption of interference fields caused by scar tissue. Local anesthetics promote anti-inflammatory activity through a variety of mechanisms including reversibly inhibiting leukocyte adhesion by interfering with the action of integrins and leukocyte adhesion molecule-1, limiting leukocyte migration, reversible inhibition of phagocytosis, inhibition of phospholipase A2, inhibition of prostaglandins, inhibition of thromboxane release, inhibition of leukotriene release, inhibition of histamine release, reduction in free radical formation, and inhibition of cytokine release. Additionally, Lidocaine injection is proposed to alleviate nerve entrapment within fascia through hydrodissection, a technique being effectively utilized in the management of carpal tunnel syndrome.
Scar deactivation is the technique of inserting acupuncture needles at a 30-45 degree angle into the superficial fascia to surround a scar. It is postulated that needle insertion into connective tissue produces analgesia through a multifaceted process encompassing the disruption and remodeling of extracellular matrix in loose connective tissue, alterations in gene expression affecting neurotransmitter levels, and cellular signaling pathways impacted in response to fibroblast and mast-cell involvement. In traditional Chinese medicine, injuries resulting in scar tissue formation are thought of as areas of blood and subsequently Qi stagnation. Disruptions in the flow of Qi at the point of scar tissue can result in abnormal skin sensations such as pain, itching, and numbness in addition to systemic effects. A case report has demonstrated effective pain relief in with an acupuncture protocol utilizing scar deactivation technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scar Deactivation Surface Release | Experimental | Other: Scar Deactivation Surface Release Technique protocolAlternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment. |
| Scar Infiltration with 0.25-1% Lidocaine | Experimental | Other: Scar Infiltration with 0.25-1% LidocaineWill consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose. |
| Physical Therapy | Experimental | Other: Physical therapyWill be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female DoD beneficiaries age 18 years or older
- 3 months or greater postpartum with abdominal and/or back pain starting after low transverse Cesarean section scar.
- If subject has had prior Scar Deactivation with Surface Release Technique for cesarean section scar they must have completed a washout period of 12 weeks or more.
Key exclusion criteria (6 listed)
- Pregnant
- Prior Scar Deactivation with Surface Release Technique for cesarean section scar within the last 12 weeks.
- Ever had Prior Scar Infiltration with Lidocaine for cesarean section.
- Active cellulitis surrounding scar
- Revision of Cesarean section scar
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 |
|---|---|---|
| Scar Deactivation Surface Release Technique protocol▪ Alternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment. | Other | Scar Deactivation Surface Release |
| Scar Infiltration with 0.25-1% Lidocaine▪ Will consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose. | Other | Scar Infiltration with 0.25-1% Lidocaine |
| Physical therapy▪ Will be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain. | Other | Physical Therapy |
Primary outcome
Change in Defense and Veterans Pain Rating Scale (DVPRS) between each time frame
Time frame: time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks
The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VHA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used. The goal for pain reductions will be 50% as a primary outcome.
Change in Patient and Observer Scar Assessment Scale (POSAS) between each time frame
Time frame: time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks
The Patient and Observer Scar Assessment Scale consists of the total score of two numeric scales measured by the patient and a qualified observer. Each scale assesses the scar by six characteristics on 10-point scales with a 1 corresponding to normal skin and a 10 representing the worst imaginable condition for that characteristic. The Total Score of both scales is calculated by summing scores of the six items resulting in a range of 6 to 60. The POSAS is treated as an interval variable; therefore, parametric methods will be used for this outcome.
2 secondary outcomes
Single question asking if subjects' expectations were met? -- Binary yes/no
Time frame: 20 weeeks
Single question asking subjects' change in pain severity reported as a percentile (10%, 20%, ...)
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Background: PubMed 28135188Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
- Background: PubMed 27814873Wasserman JB, Steele-Thornborrow JL, Yuen JS, Halkiotis M, Riggins EM. Chronic caesarian section scar pain treated with fascial scar release techniques: A case series. J Bodyw Mov Ther. 2016 Oct;20(4):906-913. doi: 10.1016/j.jbmt.2016.02.011. Epub 2016 Mar 10.
- Background: PubMed 23657643Okabayashi K, Ashrafian H, Zacharakis E, Hasegawa H, Kitagawa Y, Athanasiou T, Darzi A. Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity. Surg Today. 2014 Mar;44(3):405-20. doi: 10.1007/s00595-013-0591-8. Epub 2013 May 9.
- Background: PubMed 11515832Suleiman S, Johnston DE. The abdominal wall: an overlooked source of pain. Am Fam Physician. 2001 Aug 1;64(3):431-8.
- Background: PubMed 12003414Srinivasan R, Greenbaum DS. Chronic abdominal wall pain: a frequently overlooked problem. Practical approach to diagnosis and management. Am J Gastroenterol. 2002 Apr;97(4):824-30. doi: 10.1111/j.1572-0241.2002.05662.x.
- Background: PubMed 18378742Loos MJ, Scheltinga MR, Mulders LG, Roumen RM. The Pfannenstiel incision as a source of chronic pain. Obstet Gynecol. 2008 Apr;111(4):839-46. doi: 10.1097/AOG.0b013e31816a4efa.
- Background: PubMed 26926975Speer LM, Mushkbar S, Erbele T. Chronic Pelvic Pain in Women. Am Fam Physician. 2016 Mar 1;93(5):380-7.
- BackgroundBrobyn TL, MK Chung, and PJ LaRiccia "Neural therapy: An overlooked game changer for patients suffering chronic pain?" J Pain Relief 2015;4: 184.
- BackgroundWeinschenk S. "Neural therapy--A review of the therapeutic use of local anesthetics" Acupuncture and Related Therapies 2012.
- Background: PubMed 26115657Egli S, Pfister M, Ludin SM, Puente de la Vega K, Busato A, Fischer L. Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients. BMC Complement Altern Med. 2015 Jun 27;15:200. doi: 10.1186/s12906-015-0735-z.
- Background: PubMed 10969322Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
- Background: PubMed 16480459Cassuto J, Sinclair R, Bonderovic M. Anti-inflammatory properties of local anesthetics and their present and potential clinical implications. Acta Anaesthesiol Scand. 2006 Mar;50(3):265-82. doi: 10.1111/j.1399-6576.2006.00936.x.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scar Deactivation Surface Release Technique protocol, Scar Infiltration with 0.25-1% Lidocaine and Physical therapy in people with Scar and Cesarean Section; Dehiscence, run by Jennifer Loomis at 1 site 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 6 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: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Defense and Veterans Pain Rating Scale (DVPRS) between each time frame (time frame: time 0, 4 weeks, 8 weeks, 16 weeks, 20 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?
On the ClinicalTrials.gov record for NCT03936309, which also lists 16 linked publications.
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 9 Apr 2025.