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

October 27, 2022 updated by: Al Shaymaa Shaaban Abd El Azeim, Cairo University

Effect of Segmental Control Program on Hamstring Peak Torque,Pain,Function and Range of Motion in Patients With Non-specific Low Back Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11251
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: local segmental control and closed kinetic chain
the patients will receive local segmental control and closed kinetic chain three times a week for four weeks
Other: local segmental control and closed kinetic chain
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
Other: traditional therapy
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
EXPERIMENTAL: local segmental control and open kinetic chain
the patients will receive local segmental control and open kinetic chain three times a week for four weeks
Other: traditional therapy
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
Other: local segmental control and open kinetic chain
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.
ACTIVE_COMPARATOR: traditional therapy
the patients will receive traditional therapy three times a week for four week
Other: traditional therapy
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
peak torque
Time Frame: up to four weeks
isokinetic will be used for measuring hamstring peak torque
up to four weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to four weeks
visual analogue scale will be used for assessment of pain intensity
up to four weeks
disability
Time Frame: up to four weeks
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.
up to four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • p.t.REC/012/002673

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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