Effects of Neural Slump Mobilization in Addition to Conventional Physical Therapy in Low Back Pain

August 14, 2022 updated by: Foundation University Islamabad
Low back pain is amongst the most prevalent musculoskeletal conditions worldwide.This condition has a significant impact on the person's quality of life by effecting their various activities of daily living. As of 2017 it remains the leading cause of years lived with disability.Various management strategies are used for the treatment of low back pain. In the recent years neurodynamic techniques are being used for the treatment of low back pain. Escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. Slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.Different studies have shown postive results of slump stretching in patients of low back pain. However no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.So this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back Low back pain is amongst the most prevalent musculoskeletal conditions worldwide.This condition has a significant impact on the person's quality of life by effecting their various activities of daily living. As of 2017 it remains the leading cause of years lived with disability.Various management strategies are used for the treatment of low back pain. In the recent years neurodynamic techniques are being used for the treatment of low back pain. Escpecially, patients of low back pain who have neural mechanosensitivity may benefit from neural mobilization techniques. Slump stretching is a neurodynamic technqiue which is used to improve the mobility of dural tissue.Different studies have shown postive results of slump stretching in patients of low back pain. However no such study has investigated the role of slump stretching in improving range of motiion in low back pain patients.So this study aims to investigate the the effect of slump stretching in low back pain patients specially on low back

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

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 (Anticipated)

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.
42

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

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Fauji Foundation Hospital

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

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18-44 years
  • Both males and females
  • Persons with low back pain with a positive slump test
  • Patients with a NPRS intensity of at least 5

Exclusion Criteria:

  • Patients with signs or symptoms of nerve root involvement
  • Pregnant females, patients with history of spinal surgery, patients of spondylolistheis, spinal stenosis and disc herniation.
  • Patients with serious spinal conditions infection, tumors, osteoporosis, spinal fracture

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 Assignment
  • Masking: Single

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.
Active Comparator: conventional physical therapy
Procedure: Conventional Physical Therapy
Moist heat with hydro collator pack, Maitland Mobilization for Lumbar spine, Therapeutic exercise: Core stability exercises
Experimental: conventional physical therapy with slump stretching
Procedure: Conventional Physical Therapy
Moist heat with hydro collator pack, Maitland Mobilization for Lumbar spine, Therapeutic exercise: Core stability exercises
Procedure: Neural slump mobilization
Slump stretching will be performed with the patient in the long sitting position with the patient's feet against the wall to assure the ankle remained in 0 degree dorsiflexion. The therapist will apply over pressure to the cervical spine flexion to the point where the patient's symptoms will be reproduced. The position will be held for 30 s. A total of 5 repetitions will be completed.

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
ROM
Time Frame: 2 weeks
Range of motion will be measured with gravity based inclinometer. One inclinometer will be placed on T12 spinous process and the second inclinometer will be placed on S1 spinous process of participant. The patient is asked to perform forward flexion, extension and lateral flexion, The range of motion is recorded by subtracting the value on lower inclinometer from upper inclinometer.
2 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
Back Pain
Time Frame: 2 weeks
Back Pain will be measured via Numeric Pain Rating Scale. A higher score will signify higher level of pain.
2 weeks
Physical Function
Time Frame: 2 weeks
Repeated sit to stand test will be used to assess the physical function of the participant
2 weeks
Disability
Time Frame: 2 weeks
Disability will be assessed via Pain Disability Index. A higher score signifies poor outcome
2 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.
Foundation University Islamabad

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 1, 2022

Primary Completion (Anticipated)

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.
January 1, 2023

Study Completion (Anticipated)

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.
February 1, 2023

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).
August 10, 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.
August 14, 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.
August 16, 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.
August 16, 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.
August 14, 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.
August 1, 2022

More Information

Terms related to this study

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.
  • FUI/CTR/2022/8

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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