A Comparison of Scar Infiltration, Scar Deactivation, and Standard of Care for the Treatment of Chronic, Post-Surgical Pain After Cesarean Section

NCT03936309 | Completed

• 1 other identifier: FWH20190005H
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 Cesarean section compared to standard of care physical therapy with the McKenzie Method.

Conditions

Scar; Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  time 0, 4 weeks, 8 weeks, 16 weeks, 20 weeks

Secondary Outcomes (2)

• Single question asking if subjects' expectations were met? -- Binary yes/no

  20 weeeks

• Single question asking subjects' change in pain severity reported as a percentile (10%, 20%, ...)

  20 weeks

Study Arms (3)

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.

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.

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.

Other: Physical therapy

Interventions

Scar Deactivation Surface Release Technique protocol OTHER

▪ 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 Deactivation Surface Release

Scar Infiltration with 0.25-1% Lidocaine OTHER

▪ 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.

Scar Infiltration with 0.25-1% Lidocaine

Physical therapy OTHER

▪ 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.

Physical Therapy

Eligibility Criteria

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

You may qualify if:

• Female DoD beneficiaries age 18 years or older
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Loomis: lead
• Mike O'Callaghan Military Hospital: collaborator

Study Sites (1)

375th Medical Group

Scott Air Force Base, Illinois, 62225, United States

Location

Related Publications (15)

• Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.

  PMID: 28135188 BACKGROUND

• Wasserman 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.

  PMID: 27814873 BACKGROUND

• Okabayashi 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.

  PMID: 23657643 BACKGROUND

• Suleiman S, Johnston DE. The abdominal wall: an overlooked source of pain. Am Fam Physician. 2001 Aug 1;64(3):431-8.

  PMID: 11515832 BACKGROUND

• Srinivasan 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.

  PMID: 12003414 BACKGROUND

• Loos 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.

  PMID: 18378742 BACKGROUND

• Speer LM, Mushkbar S, Erbele T. Chronic Pelvic Pain in Women. Am Fam Physician. 2016 Mar 1;93(5):380-7.

  PMID: 26926975 BACKGROUND

• Brobyn TL, MK Chung, and PJ LaRiccia "Neural therapy: An overlooked game changer for patients suffering chronic pain?" J Pain Relief 2015;4: 184.

  BACKGROUND

• Weinschenk S. "Neural therapy--A review of the therapeutic use of local anesthetics" Acupuncture and Related Therapies 2012.

  BACKGROUND

• 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.

  PMID: 26115657 BACKGROUND

• Hollmann 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.

  PMID: 10969322 BACKGROUND

• Cassuto 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.

  PMID: 16480459 BACKGROUND

• Malone, 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.

  BACKGROUND

• 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.

  PMID: 29410716 BACKGROUND

• Fang 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.

  PMID: 25441952 BACKGROUND

MeSH Terms

Conditions

Cicatrix

Interventions

Lidocaine; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 3, 2019
• Study Start: June 1, 2019
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)