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Diastasis RectiNCT06459752

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

A study testing visceral manipulation and noble technique and noble technique in people with Diastasis Recti, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 22 to 35 years, women only
Conditions the study is for
Diastasis Recti
What is being tested?
visceral manipulation and noble technique and noble technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
Jun 2024to Sep 2024
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 22 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

: Imran Amjad, PhD contact

03324390125

imran.amjad@riphah.edu.pk

Imran Amjad, PhD contact

051-5481826

imran.amjad@riphah.edu.pk

Pakistan1 site

  • DHQ Hospital Toba Tek Singh

    Toba Tek Singh, Punjab Province, 36050

    Hafiza Neelam, MS, 03204097476, hafiza.neelam@riphah.edu.pk

    Noor Fatima, MS-WH

Other trials in Pakistan

About this study

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.

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.

Read the 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

Conditions
Diastasis Recti
Being tested
visceral manipulation and noble technique, noble technique
Keywords
Diastasis recti, Low back pain, Post partum females, Visceral manipulation
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • visceral manipulation and noble techniqueOther

    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:

    1. Reveals visceral adhesions.
    2. Find tender spots.
    3. 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 techniqueOther

    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

Study groups in NCT06459752
Study groupRoleWhat they receive
Group AExperimentalThis group received three sessions a week for six weeks, with 30 minutes per session given to visceral manipulation and noble technique (15 minutes each technique).
Receives: Other: visceral manipulation and noble technique
Group BActive comparatorThis group receives three sessions a week for six weeks, with 15 minutes per session in which noble technique is applied.
Receives: Other: noble technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6th week

  2. 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.

    Measured: 6th week

  3. 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.

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459752
Sponsor's protocol ID
REC/RCR & AHS/23/0564
Status last verified
Jun 2024
First submitted
11 Jun 2024
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24256310

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

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

  • 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.

    PubMed 16638461

  • 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.

    PubMed 34363190

  • 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.

    PubMed 8677279

  • Brahmandam G, Lipsett BJ. Anatomy, Abdomen and Pelvis: Umbilical Cord. 2025 Jul 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557389/

    PubMed 32491321

  • 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.

    PubMed 24268942

  • 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.

    PubMed 28946525

Questions about this trial

What is this clinical trial studying?

A study testing visceral manipulation and noble technique and noble technique in people with Diastasis Recti, run by Riphah International University at 1 site in Pakistan.

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 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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 Pakistan. 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?

Contact : Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain: NPRS (time frame: 6th week). The study lists 3 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 NCT06459752, which also lists 9 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 14 Jun 2024.

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