Clinical trial NCT06459752: Combined Effects of Visceral Manipulation and Noble Technique on Post-partum Females With Diastasis Recti
Official title: Combined Effects of Visceral Manipulation and Noble Technique on Inter-rectal Distance, Low Back Pain and Functional Disability in Post-partum Females With Diastasis Recti.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diastasis Recti
Keywords: Diastasis recti
Low back pain
Post partum females
Visceral manipulation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diastasis recti is characterized by an abnormal expansion of the gap between the medial sides of the rectus abdominis muscle and a lengthening of the linea alba (increased inter-recti distance). It is mainly caused by excessive intra-abdominal pressure. The abdominal muscles and connective structures expand from the growing uterus during pregnancy. Low back pain is a prevalent complaint that can result from various factors, including weakened core muscles and functional disability. The aim of the study would assess of combined effect of visceral manipulation and noble technique on Inter-rectal distance, low back pain and functional disability in post-partum females with diastasis recti.

Detailed description: A randomized controlled trial will be conducted in DHQ Hospital Toba Tek Singh. A nonprobability convenience sampling technique will be used. There will be 34 participants. Participants will meet with inclusion criteria and be divided into two groups A and B. In Group A 17 participants will receive visceral manipulation technique with noble technique for 30 minutes per session, three sessions per week for 6 weeks. While in Group B 17 participants will just receive noble technique exercises for 15 min per session, three sessions per week for 6 weeks. Participants will be assessed before and after treatment through; Digital nylon calipers for diastasis recti, NPRS for pain, and Quebec Back Pain Disability Scale (QBPDS) to assess LBP-related functional. Data will be analyzed during SPSS software version 21

Eligibility criteria: Inclusion Criteria:

* Age between 22 to 35.
* Primiparous women with vaginal delivery and an IRD of \>2 cm.
* Three to six months postpartum with the presence of diastasis rectus abdominis.
* Patients having moderate low back pain in NPRS.

Exclusion Criteria:

* Acute Malignancy
* Recent Abdominal or Pelvic surgery
* Having undergone spinal surgery in the previous six months
* Serious spinal pathology
* Serious cardiovascular or metabolic disease Pregnancy
* Herniation pain

Primary outcomes:
measure: Pain: NPRS
timeFrame: 6th week
measure: disability: Quebec Back Pain Disability Scale (QBPDS)
timeFrame: 6th week
measure: Muscle separation: Digital nylon calipers
timeFrame: 6th week
Secondary outcomes:
Other outcomes:
Locations:
city: Toba Tek Singh
country: Pakistan
facility: DHQ Hospital Toba Tek Singh
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akram J, Matzen SH. Rectus abdominis diastasis. J Plast Surg Hand Surg. 2014 Jun;48(3):163-9. doi: 10.3109/2000656X.2013.859145. Epub 2013 Nov 21.
citation: Arslan OE. Anatomy of the abdominal wall. Aesthetic surgery of the abdominal wall: Springer; 2005. p. 1-28.
citation: Flament JB, Avisse C, Delattre JFJAwhp, management. Anatomy of the abdominal wall. 2001:39-63.
citation: Grevious MA, Cohen M, Shah SR, Rodriguez P. Structural and functional anatomy of the abdominal wall. Clin Plast Surg. 2006 Apr;33(2):169-79, v. doi: 10.1016/j.cps.2005.12.005.
citation: Cavalli M, Aiolfi A, Bruni PG, Manfredini L, Lombardo F, Bonfanti MT, Bona D, Campanelli G. Prevalence and risk factors for diastasis recti abdominis: a review and proposal of a new anatomical variation. Hernia. 2021 Aug;25(4):883-890. doi: 10.1007/s10029-021-02468-8. Epub 2021 Aug 6.
citation: Gilleard WL, Brown JM. Structure and function of the abdominal muscles in primigravid subjects during pregnancy and the immediate postbirth period. Phys Ther. 1996 Jul;76(7):750-62. doi: 10.1093/ptj/76.7.750.
citation: Basta M, Lipsett BJ. Anatomy, Abdomen and Pelvis: Umbilical Cord. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557389/
citation: Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.
citation: Doubkova L, Andel R, Palascakova-Springrova I, Kolar P, Kriz J, Kobesova A. Diastasis of rectus abdominis muscles in low back pain patients. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):107-112. doi: 10.3233/BMR-169687.