Combined Effects of Visceral Manipulation and Noble Technique on Post-partum Females With Diastasis Recti

Diastasis Recti Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459752
• Other study ID #: REC/RCR & AHS/23/0564
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: : Imran Amjad, PhD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti
• Diastasis, Muscle

Intervention

Other:
• visceral manipulation and noble technique
First, the patient will lie face-up on a massage or exam table. Physiotherapists feel viscera, major internal organs located in the abdomen by lightly pressing through abdominal muscles. Physiotherapist manual poking, pressing, and massage actions do three things: Reveals visceral adhesions. Find tender spots. Breaks up adhesions. Massaging and pressing stretch the collagen fibers that makeup fascia, which loosens tightly bound fibers to break up adhesions. This releases the organs and allows them to move more freely. Minor adhesions may resolve after one session. Tough, stubborn adhesions may require several sessions plus self-manipulation between sessions
• noble technique
The patient is positioned in supine with both knees bent and feet flat on a firm surface. The patient then places her crossed hands over her abdomen to support and pull the rectus abdominis muscles towards the midline. Finally, the patient is asked to slowly raise her head until a slight contraction is felt in the abdomen, holding for 20 seconds and repeating the exercise up to 20 times a day

Locations

Country	Name	City	State
Pakistan	DHQ Hospital Toba Tek Singh	Toba Tek Singh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

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. — View Citation

Arslan OE. Anatomy of the abdominal wall. Aesthetic surgery of the abdominal wall: Springer; 2005. p. 1-28.

Basta M, Lipsett BJ. Anatomy, Abdomen and Pelvis: Umbilical Cord. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557389/ — View 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. — View 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. — View 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. — View Citation

Flament JB, Avisse C, Delattre JFJAwhp, management. Anatomy of the abdominal wall. 2001:39-63.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: NPRS	The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). Cronbach's alpha value of NPRS is 0.88	6th week
Primary	disability: Quebec Back Pain Disability Scale (QBPDS)	The Quebec Back Pain Disability Scale (QBPDS) measures the extent to which people with low back pain have difficulty with everyday activities. The questionnaire is composed of 20 items on daily activities. The items were selected from 6 relevant subdomains of functional skills for patients with low back pain.	6th week
Primary	Muscle separation: Digital nylon calipers	The Digital nylon calipers are a valid tool for measuring IRD above the umbilicus. For the caliper measurements with the abdominal muscles at rest, the participant was positioned in hook-lying, arms down by the side, with 1 pillow placed beneath the head. The examiner palpated the medial borders of the right and left rectus abdominis muscle bellies at the marked locations. The inside measurement jaws of the digital nylon calipers were positioned at the locations of the palpating fingers. The intra-class correlation coefficient values exceeded 0.75 for the digital calipers.	6th week