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Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain (NSLBP)

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
local segmental control and closed kinetic chain
local segmental control and open kinetic chain
traditional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring segmental stabilization exercise, low back pain, peak torque

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients had NS LBP Patients with age from 20 to 40 years for both genders.
  2. The lumbar region of back pain lasts for 4 weeks & more has not been diagnose as a specific disease or spinal abnormality.
  3. Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%).
  4. Shortening of hamstring.
  5. The study populations must be willing to participate in the study.

Exclusion Criteria:

  1. Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease.
  2. Psychiatric/mental deficit
  3. Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.

Sites / Locations

  • Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

local segmental control and closed kinetic chain

local segmental control and open kinetic chain

traditional therapy

Arm Description

the patients will receive local segmental control and closed kinetic chain three times a week for four weeks

the patients will receive local segmental control and open kinetic chain three times a week for four weeks

the patients will receive traditional therapy three times a week for four week

Outcomes

Primary Outcome Measures

peak torque
isokinetic will be used for measuring hamstring peak torque

Secondary Outcome Measures

pain intensity
visual analogue scale will be used for assessment of pain intensity
disability
oswestry disability scale will be used for assessment of disability, Each patient was asked to answer by checking one box in each section for the statement which best applies to him. Then the marks had been counted and divided by 50 or 45.score ranging from 0 (no pain or disability) to 50 (severe pain and disability) . Then was multiplied by 100 for the percentage (score/ 50) x 100=% points. A score of 0% to 20% is minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled and 81%-100%: complete disability.

Full Information

First Posted
March 11, 2022
Last Updated
October 27, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05288946
Brief Title
Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain
Acronym
NSLBP
Official Title
Effect of Segmental Control Program on Hamstring Peak Torque,Pain,Function and Range of Motion in Patients With Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

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

5. Study Description

Brief Summary
The purpose of this study is to investigate the effect of segmental control exercises program on hamstring peak torque, pain, function, and ROM in patients with non-specific low back pain.
Detailed Description
Low back pain (LBP) is a significant health problem internationally characterized by various biophysical, psychological, and social dimensions affecting functioning, societal participation, and personal financial prosperity.The reported prevalence of LBP was high, especially for chronic non-specific low back pain, approximately 15.4%. of which chronic low back pain was about 2.5 times more prevalent in the working population compared to the non-working group. Recently, there has been a focus on lumbar stabilization exercises that prove to be effective and may be superior to general exercises for LBP management. The approach is aimed at improving the neuromuscular control, strength, and endurance of the active subsystem stabilizing the spine. Several groups of muscles are particularly targeted namely, the transverses abdominis and the multifidus muscles that are central to maintain spinal and trunk stability. But also other core muscles are involved. so this study will be conducted to investigate the effect of segmental stabilization exercise on low back pain. forty-five patients will be allocated to three groups. first experimental will receive segmental stabilization phase 1 and phase 2, second experimental will receive segmental stabilization phase 1 and 3, the third one is the control group and receives traditional treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
segmental stabilization exercise, low back pain, peak torque

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
segmental stabilization exercises
Masking
InvestigatorOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local segmental control and closed kinetic chain
Arm Type
Experimental
Arm Description
the patients will receive local segmental control and closed kinetic chain three times a week for four weeks
Arm Title
local segmental control and open kinetic chain
Arm Type
Experimental
Arm Description
the patients will receive local segmental control and open kinetic chain three times a week for four weeks
Arm Title
traditional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive traditional therapy three times a week for four week
Intervention Type
Other
Intervention Name(s)
local segmental control and closed kinetic chain
Intervention Description
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then closed kinetic chain exercise in the form of Stand-up position on unstable surface, Closed chain lunge exercises, with the addition of hand weights, Bridge in prone position, Bridge in supine position, Lateral Bridge
Intervention Type
Other
Intervention Name(s)
local segmental control and open kinetic chain
Intervention Description
the patients will receive Lumbar multifidus activation and Transversus abdominis activation then open kinetic chain in the form of Lower limb abduction, Knee extension in a supine position on a roller, Open chain exercise of the upper limb after co-contraction of transversus abdominis and multifidus.
Intervention Type
Other
Intervention Name(s)
traditional therapy
Intervention Description
the patients will receive exercise in the form of Sitting knee raise on gym ball to maintain stability in the presence of hip movement on a reduced base of support, abdominal slide to control action of the rectus abdominis while moving, Lying trunk curl with leg lift to strengthen upper and lower abdominals (figure 1-6), Basic superman to strengthen the spinal and hip extensors
Primary Outcome Measure Information:
Title
peak torque
Description
isokinetic will be used for measuring hamstring peak torque
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
pain intensity
Description
visual analogue scale will be used for assessment of pain intensity
Time Frame
up to four weeks
Title
disability
Description
oswestry disability scale will be used for assessment of disability, Each patient was asked to answer by checking one box in each section for the statement which best applies to him. Then the marks had been counted and divided by 50 or 45.score ranging from 0 (no pain or disability) to 50 (severe pain and disability) . Then was multiplied by 100 for the percentage (score/ 50) x 100=% points. A score of 0% to 20% is minimal disability, 21%-40%: moderate disability, 41%-60%: severe disability, 61%-80%: crippled and 81%-100%: complete disability.
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients had NS LBP Patients with age from 20 to 40 years for both genders. The lumbar region of back pain lasts for 4 weeks & more has not been diagnose as a specific disease or spinal abnormality. Mild to moderate disability according to the Oswestry Disability Index (ODI) (up to 40%). Shortening of hamstring. The study populations must be willing to participate in the study. Exclusion Criteria: Neurological, systemic illness and infectious diseases such as rheumatologic diseases, tumor, cardiovascular disease. Psychiatric/mental deficit Patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment.
Facility Information:
Facility Name
Cairo University
City
Giza
ZIP/Postal Code
11251
Country
Egypt

12. IPD Sharing Statement

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Effect of Segmental Control Program on Hamstring Peak Torque in Patients With Non-specific Low Back Pain

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