CClinicalTrials.gg
CompletedNCT06066567Updated Mar 19, 2025

INFLUENCE of COMBINED INTERFERENTIAL CURRENT STIMULATION and ABDOMINAL DRAW-IN EXERCISES in the TREATMENT of CHRONIC NON-SPECIFIC LOW BACK PAIN

An interventional study of Interferential current stimulation and Draw- In exercises,, in To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic N, sponsored by Cairo University. Completed at 2 sites in Egypt. Open to participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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

Read the 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).

02

Conditions studied

  • To Investigate Influence of a Combined Interferential Current Stimulation and Abdominal Draw -in Exercises in Patients with Chronic N
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 60 patients with chronic non-specific low back pain (>3 months).
    1. 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Experimental: treatment group

    Device: Interferential current stimulation · Other: Draw- In exercises,,

  • Active comparator
    control group

    Other: Draw- In exercises,,

Interventions

  • DeviceInterferential current stimulation

    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

    Also known as: Draw- In exercises,,, hot pack, back muscles stretching, strengthening exercises for the back and abdominal muscles.

  • OtherDraw- In exercises,,

    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

    Also known as: back muscles stretching, strengthening exercises for the back and abdominal muscles., hot pack

06

What researchers measure

Primary outcomes

  1. Abdominal muscle thickness

    TrA, External Oblique (EO) and Internal Oblique (IO) with Ultrasonography imaging examination.

    Time frame: 4 weeks

  2. Transverse abdominis (TrA) muscle endurance

    Transverse abdominis (TrA) muscle endurance with prone endurance test guided by Pressure Biofeedback Unit (PBU).

    Time frame: 4 weeks

  3. Pain intensity

    Pain intensity with visual analogue scale (VAS).

    Time frame: 4 weeks

  4. . Functional disability

    Functional disability with Arabic version of Oswestry Disability Index (ODI).

    Time frame: 4 weeks

07

Study locations

2 sites
  • Cairo University
    Giza, 3387722, Egypt
  • Faculty of physical therapy
    Giza, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06066567
Lead sponsor
Cairo University
Responsible party
Doaa Rafat (Lecturer of physical therapy, Cairo University) — Principal investigator
First posted
Oct 4, 2023
Start date
Nov 1, 2023
Primary completion
May 1, 2024
Completion
Jun 1, 2024
Last update
Mar 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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