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Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05953922
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: core stability exersises
 N/A

Detailed Description

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

This study is delimited to the following aspects:

  1. Fifty, patients of only females with chronic non specific low back pain more than 3 months.

  2. The age will range from 22 to 45 years.

  3. The treatment will conduct to three session per week for four weeks .

  4. The selected patients will assigned randomly to two equal groups:

1- Group1 (intervention), will do the selected treatment that include electrical stimulation in addition to Core stability exercises program. 2- Group2(control), will do the conventional treatment only.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
intervention studyintervention study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Core Stability Exercises on Pain and Quality of Life in Non Specific Low Back Pain
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: treatment group

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
core stability exercises and transcutaneous electrical nerve stimulation for four week three session per week
Other Names:
  • transcutaneous electrical nerve stimulation

    		•
    No Intervention: control group

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

    Outcome Measures

    Primary Outcome Measures

    1. quality of life for each participants [baseline]

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

    2. pain levels for each participants [baseline]

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

    3. pressure lumber biofeedback for each participants [baseline]

      pressure lumber biofeedback for asses transverse abdominis contraction

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Physical Therapy, Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wafaa Ahmed Salama Ashour, physical therapist, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05953922
    Other Study ID Numbers:
    • non specific low back pain
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Jul 20, 2023