NCT06495099

Brief Summary

Brief Summary: Low back pain (LBP) is an important public health problem due to the increasing world population and aging. In chronic LBP, exercise therapy is among the first-line treatments. Core stabilization exercises (CSE), one of the motor control exercises, focus on the activation and control of the deep spinal muscles. Recently, some studies have shown that Russian electrical stimulation alone or combined with exercise can provide contraction in deep stabilizer muscles and significantly reduce pain in patients with LBP

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

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

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable low-back-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

July 2, 2024

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain scoring

    pain measured by VAS tool, 0 the least pain while 10 the highest one

    6 weeks

  • Quality of life by using Oswestry Disability Index (OID)

    questioner, Score from 0 to 19% indicate minimal disability- 20 to 39% represent moderate disability- 40 to 59% represent severe disability- 60 to 79% represent crippled disability- and scores from 80 to 100% represents patients that are confined to bed

    6 weeks

Secondary Outcomes (2)

  • Muscle thickness assessment

    6 weeks

  • Stability and mobility of spine

    6 weeks

Study Arms (2)

group A

EXPERIMENTAL

The training group A will be treated by core stability exercises and Russian electrical stimulation

Other: Russian electrical stimulation

group B

ACTIVE COMPARATOR

The training group B will be treated by core stability exercises.

Other: Russian electrical stimulation

Interventions

Type of Medium frequency current with 2500 Hz frequency modulated at 50 Hz with 50% Duty cycle training protocol is (10 sec. on time - 50 sec. off time - 10 minutes total time)

group Agroup B

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The duration of the disease is more than 3 months with pain scores greater than four in the VAS disability score of 19% or greater as evident from the modified oswestry disability.

You may not qualify if:

  • Neurological or musculoskeletal diseases that affect lumbar spine (e.g: lumbar spondylosis, spondylolisthesis, and lumbar disc injuries)
  • women during pregnancy and lactation.
  • History of lumbar spine surgery.
  • Signs of lumbar radiculopathy or myelopathy.
  • Signs of serious pathology (e.g., malignancy, inflammatory disorders, infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

March 10, 2024

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations