NCT05834153

Brief Summary

To compare the effects of kinesiotaping and electrical muscle stimulation on low back pain and disability associated with diastasis recti.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

April 18, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

kinesiotapingelectrical muscle stimulationlow back paindiastasis rectiexercises

Outcome Measures

Primary Outcomes (4)

  • Numeric pain rating scale

    Numeric pain rating scale (an outcome measure) is a pain screening tool commonly used to assess pain severity using a 0 to 10 scale, with 0 measuring no pain and 10 meaning worst pain

    4th week

  • Manual muscle testing MMT

    The strength of rectus abdominis muscle will recorded on a 0 to 5-point scale using manual muscle test suggested by Dr. Lovett. The patients will positioned in a supine, crook lying attitude with the arms straight by the side. The subjects will directed to lift and reach upwards till the scapular lower end level and if the subject will able to achieve and hold this position successfully then will ask to perform the next position by crossing the hands over the chest and then leaning forward and lifting the scapula off the table. After the patient achieved this position successfully forward reaching with hands crossed and supporting at the back of the head will perform. The scores will recorded based on the position that the patient could achieve and sustain successfully i.e. scores 3, 4 and 5 respectively for the above mentioned positions

    4th week

  • Roland Morris Disability Questionnaire (RMDQ) for disability

    The questionnaire was used to measure the level and severity of disability occurring due to low back pain reflected by higher numbers on a 24-point scale. The questionnaire was taken at the beginning and after completion of the protocol and the clinical improvement was calculated based on the score

    4th week

  • Caliper method

    Inter Recti Distance (IRD): The inter recti distance measurement was done by the use of a skin tone caliper. The IRD was measured at three levels both pre and post protocol, that is 2 or more than 2.5 cm above and below the umbilicus and at the umbilicus

    4th week

Study Arms (2)

kinesiotaping

EXPERIMENTAL
Device: kinesiotaping

electrical muscle stimulation

ACTIVE COMPARATOR
Device: electrical muscle stimulation

Interventions

This group underwent a KT application on rectus abdominis muscle (RAM), oblique abdominal muscles (OAM) and cesarean incision twice a week for a period of 4 weeks. First, the scar technique will apply using I band with a tension of 50 % on cesarean incision when the patient will be in supine position. Then, tape will apply on RAM using muscle technique from origin to insertion of the muscle with a tension between 15 and 25 %. Band will start on symphysis pubis with no tension, and then the patient was asked to stretch the abdominal region by deep abdominal respiration, and it will ended on xiphoid process. Finally, it will perform on the right and left external oblique muscles. The procedure will start with no tension from the bottom end of the 6-12th ribs and then the hip will placed in flexion and rotation to the opposite direction and the band will taped on pubic bone with a tension between 15 and 25 %

kinesiotaping

It consists of 24 patients who will receive NMES and core stabilization exercises. The subjects will explain to relax their abdominal muscles while application Stimulation will apply by four large rectangular electrodes placed over the origin (pubic crest) and insertion (xiphoid process) of the rectus abdominis muscles bilaterally. Straps will used to fix the electrodes in place. A frequency of 80 pulses/min and with a pulse width of 0.1-0.5ms, will the parameter settings apply in this study. The total time for the application of stimulation will 30mins and until a good enough observable muscle contraction will achieve a gradual increase in intensity will perform

electrical muscle stimulation

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsdiastasis recti
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diastasis recti more than 2 or 2.5cm
  • weeks' postpartum cesarean section females
  • Primigravida females
  • Low back pain due to DR

You may not qualify if:

  • Normal vaginal delivery
  • Episiotomy
  • Multigravida women's
  • History of abdominal hernia
  • History of any abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ hospital

Gujranwala, Punjab Province, 05499, Pakistan

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • hina gul, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

October 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations