search
Back to results

INFLUENCE OF COMBINED INTERFERENTIAL CURRENT STIMULATION AND ABDOMINAL DRAW-IN EXERCISES IN THE TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

Primary Purpose

to Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients With Chronic n

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Interferential current stimulation
Draw- In exercises,,
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for to Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients With Chronic n

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 60 patients with chronic non-specific low back pain (>3 months). 2. Age of participants will range from 20 to 45 years. 3.Both sexes will participate in this study. 4.Body mass index (BMI) will range from 25 to 29.9 (Kg / m2). Exclusion Criteria: Subjects will be excluded from the study if they have previous spinal surgery, spinal cord injury or unstable neurological signs, Lumbar intervertebral disc, congenital postural deformities, inability to contract the abdominal muscles, cauda equine symptoms related to the spine including changes in bowel and bladder control, cardiac pacemaker, and females during pregnancy.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: treatment group

control group

Arm Description

Outcomes

Primary Outcome Measures

Abdominal muscle thickness
TrA, External Oblique (EO) and Internal Oblique (IO) with Ultrasonography imaging examination.
Transverse abdominis (TrA) muscle endurance
Transverse abdominis (TrA) muscle endurance with prone endurance test guided by Pressure Biofeedback Unit (PBU).
Pain intensity
Pain intensity with visual analogue scale (VAS).
. Functional disability
Functional disability with Arabic version of Oswestry Disability Index (ODI).

Secondary Outcome Measures

Full Information

First Posted
September 27, 2023
Last Updated
September 27, 2023
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT06066567
Brief Title
INFLUENCE OF COMBINED INTERFERENTIAL CURRENT STIMULATION AND ABDOMINAL DRAW-IN EXERCISES IN THE TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
Official Title
INFLUENCE OF COMBINED INTERFERENTIAL CURRENT STIMULATION AND ABDOMINAL DRAW-IN EXERCISES IN THE TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate influence of a combined interferential (IF) current stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP) CNSLBP is considered the second most common health problem after headache. The lifetime of LBP among Egyptian patients in a family center reached 48%, which indicates that LBP is a prevalent symptom that deserves more attention. One hypothesis for the development of LBP is due to a dysfunction in the control of the abdominal and back muscles and this change in spinal control is due in part to in local segmental muscles dysfunction, such as the transversus abdominis (TrA). Interferential therapy (IFT) is capable of achieving uniform stimulation and high reproducibility, it is thought to be less stressful, as well as enhance deep muscle contraction. Also, there is the specific training of the TrA provided functional and therapeutic benefits, such as unloading of the spine, anticipatory postural control, intersegmental stabilization of the spine, and long-term pain relief. Draw-in is a typical TrA exercise. Many studies have mainly focused on the morphological aspects of paraspinal muscles which play an essential role in patients with CNSLBP while our study focused on influence of a combined IFT stimulation and abdominal draw-in exercises on the abdominal muscle thickness, TrA endurance, pain intensity and function disability in patients with chronic non-specific LBP (CNSLBP
Detailed Description
60 patients suffering from chronic non-specific low back pain will participate in this study. Both sexes will participate in this study; aged 20-45 years. will be diagnosed and referred from Orthopedist. The study will be conducted at outpatient clinic of Deraya university Elmina government. The patients will be divided randomly into two groups equal in numbers (group A), (group B). Group(A): (Experimental group) :( 30 patients will receive IFC stimulation, Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles). Group(B): (control group) (30 patients will receive Draw In exercises from prone position, hot pack, back muscles stretching and strengthening exercises for the back and abdominal muscles).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
to Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients With Chronic n

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: treatment group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Interferential current stimulation
Other Intervention Name(s)
Draw- In exercises,,, hot pack, back muscles stretching, strengthening exercises for the back and abdominal muscles.
Intervention Description
IF Current parameters will be applied as follow: Amplitude modulated frequency (AMF) 30Hz, Autosweep-5 sec, Dose-15 minutes, type of current dynamic vector field (Mitra, 2006), three days per week over four weeks (Corrêa et al., 2016) and current intensity will be increased gradually, according to the subject's condition
Intervention Type
Other
Intervention Name(s)
Draw- In exercises,,
Other Intervention Name(s)
back muscles stretching, strengthening exercises for the back and abdominal muscles., hot pack
Intervention Description
From prone position, participants will lay face down on the bed and flexed their hips and knees at 0°. A PBU will be positioned below the pubis symphysis with the decreasing edge consistent with the ASIS and will be overstated to 70 mmHg. The participants will be trained to gently draw in the lower part of the abdomen under the navel. In addition, while maintaining the neutral pelvic position, the movement of the upper part of the abdomen will be restricted so that the pressure will be decreased by approximately 10 mmHg. The participants will maintain this position for 10 s
Primary Outcome Measure Information:
Title
Abdominal muscle thickness
Description
TrA, External Oblique (EO) and Internal Oblique (IO) with Ultrasonography imaging examination.
Time Frame
4 weeks
Title
Transverse abdominis (TrA) muscle endurance
Description
Transverse abdominis (TrA) muscle endurance with prone endurance test guided by Pressure Biofeedback Unit (PBU).
Time Frame
4 weeks
Title
Pain intensity
Description
Pain intensity with visual analogue scale (VAS).
Time Frame
4 weeks
Title
. Functional disability
Description
Functional disability with Arabic version of Oswestry Disability Index (ODI).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60 patients with chronic non-specific low back pain (>3 months). 2. Age of participants will range from 20 to 45 years. 3.Both sexes will participate in this study. 4.Body mass index (BMI) will range from 25 to 29.9 (Kg / m2). Exclusion Criteria: Subjects will be excluded from the study if they have previous spinal surgery, spinal cord injury or unstable neurological signs, Lumbar intervertebral disc, congenital postural deformities, inability to contract the abdominal muscles, cauda equine symptoms related to the spine including changes in bowel and bladder control, cardiac pacemaker, and females during pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghady Yasser, PHD student
Phone
01023500233
Email
ghady.yasser@deraya.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Doaa Rafat, PHD
Phone
01005591580
Email
doaa.rafat@pt.cu.edu.eg
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
3387722
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasser Ramzy, PHD
Phone
01005251562
Email
dr_yasser_1977@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

INFLUENCE OF COMBINED INTERFERENTIAL CURRENT STIMULATION AND ABDOMINAL DRAW-IN EXERCISES IN THE TREATMENT OF CHRONIC NON-SPECIFIC LOW BACK PAIN

We'll reach out to this number within 24 hrs