NCT05953922

Brief Summary

Most publications state that core stability exercises (transverse abdominis and multifidus training) can relieve chronic low back pain with or without radiculopathy and improve function, although only temporarily, and may have the same impact as active general exercise so The goal of this study is to detect the effect of retraining the deep core muscles, on pain, disability, and quality of life in patients with chronic Non specific low back pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

May 7, 2023

Last Update Submit

July 19, 2023

Conditions

Non Specific Low Back Pain

Outcome Measures

Primary Outcomes (3)

  • quality of life for each participants

    We will use the Arabic version of world health organization's quality of life (Arabic\_WHOQOL-BREF) questionnaire and higher score means better outcome

    baseline

  • pain levels for each participants

    visual analogue scale will be used to assess the level of pain and higher score means worse outcome

    baseline

  • pressure lumber biofeedback for each participants

    pressure lumber biofeedback for asses transverse abdominis contraction

    baseline

Study Arms (2)

treatment group

ACTIVE COMPARATOR

The treatment group will engage in transcutaneous electrical stimulation (TENS) and core stability exercises for three sessions each week for four weeks.

Other: core stability exersises

control group

NO INTERVENTION

The transcutaneous electrical stimulation nerve stimulation will be administered to the control group just for three sessions each week for four weeks.

Interventions

core stability exersisesOTHER

core stability exercises and transcutaneous electrical nerve stimulation for four week three session per week

Also known as: transcutaneous electrical nerve stimulation
treatment group

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemales
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • gender is women
  • age ranges from 22 to45 years old
  • chronic non specific low back pain for at least 3 month
  • pain score will between 3 to 6 on visual analogue scale

You may not qualify if:

  • Any deformity of the spine
  • Red flags including serious pathology
  • Systemic or inflammatory disease
  • sever osteoporosis
  • history of tumor or cancer
  • spine infection
  • history of spine or pelvis surgery or fracture
  • cauda equina syndrome
  • progressive neurological deficit
  • severe instability
  • sever cardio vascular or metabolic disease
  • history of psychological disease
  • anatomical and congenital disturbance
  • continuous pain more than 8 on (visual analogue scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • EMAN M. FAYEZ, Professor

    Physical Therapy for Neuromuscular Disorder and Its Surgery

    STUDY CHAIR

  • Hossam M. Alsaid, Lecturer

    Physical Therapy for Neuromuscular Disorder and Its Surgery

    STUDY CHAIR

  • MARIHAN Z. Aziz, Lecturer

    Physical Therapy for Musculoskeletal Disorders and its Surgery

    STUDY CHAIR

Central Study Contacts

Wafaa A. Salama Ashour, Bachelor's

CONTACT

01008983388pt.w.ahmedashour@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

May 7, 2023

First Posted

July 20, 2023

Study Start

October 1, 2022

Primary Completion

July 1, 2023

Study Completion

September 1, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

EG(1)