Spinal Decompression Therapy in Radicular Chronic Low Back Pain

September 2, 2021 updated by: Mir Arif Hussain, Aqua Medical Services (Pvt) Ltd

Effect of Spinal Decompression Therapy With Core Stability Exercises in Radicular Chronic Low Back Pain

The study design was randomized control trial and sampling technique was lottery method. After inclusion and exclusion criteria, sample populations were divided into experimental (group A) and control group (group B). Spinal decompression therapy in combination with core stability exercises were given to experimental group as intervention while spinal decompression therapy given alone to the control group. Assessment was taken on after 1st session, 4th session and 8th session of physical therapy intervention. Data were entered and analyzed by SPSS version 21.

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

Lower back pain is a common disorder that include any discomfort in the lumbar area below the origin of ribs and above the area of buttocks.Lower back pain with disability is 2nd most often reason for the wastage of time & money.Almost all people suffer from lower back pain at some age of their life .Both genders are effected equally by low back pain. The common problem of lower back pain are when you lift a heavy object prolonged unsupported sitting, accidents, sedentary life style. Sedentary life style could be the cause of low back pain usually when strenuous workout done on weekends as compared to minimal activities on week days. Lumbar area of the back hold and support the weight of the upper body and body do twisting and bending at this area. Specific or non-specific lower back pain is the classifications. Pain caused by any deformity, injury or any physical activity is called non-specific lower back pain.Non-specific lower back pain cannot be having any specific pathology, changes in behavior of movement pattern due to fear avoidance having bad postural control cause this non-specific pain.Lower back pain is one of the general health setbacks globally. It is the leading cause of people's absence from work and limits their activities.Prevalence and burden of low back pain increased with aging.Spinal decompression can create a opposite intradiscal pressure to promote led back of the herniated or bulging disc material and this oppsosity in the disc will cause influx of healing nutrients and other substances into the disc Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.A strong core is important to the healthy spine. Abdominal muscle can help the back muscle supporting supine. If core muscle are weak, supine carry extra pressure on your back muscles. For this stabilizing and core exercises are important to strengthen back spine. By increasing endurance of these muscles core muscle should be strong. Core stability program improves functional status; reduce pain, increases quality of life and endurance of muscles in lumbar disk herniation patients.In 2008, a researcher found that stabilization exercises helpful in spinal rehabilitation to prevent from any sports injury. Another study by Hodges in 2003 stated that exercises for central muscle is an developing process; additional work necessary to purify and authenticate move forward, mainly with reference to understand the neurobiology of chronic pain.A study in 2011 on comparison between stabilization plan and Pilates technique for treating Low back pain. Their results showed that, Pereira technique is not is not helpful in get better back pain and function, in comparison with control and lumbar stabilization exercise groups.In exercise plan Mat and gym ball exercise for strength training and step box were used to develop an independent habit of exercise .these exercise plan intend to increase strength of muscle and decrease pain. As a main exercise walking is, safe, suitable and easy to decrease low back pain because it does not involve forceful and twisting forward flexion.

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.
40

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
    • Federal
      • Islamabad, Federal, Pakistan, 44000
        • Aqua research Center

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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Radicular low back pain with minimum 3 months of duration
  • Both gender ( male and female)
  • Age 20-60 years
  • Limited Straight Leg Raise.

Exclusion Criteria:

  • With marked bony and soft tissue disease.
  • Less than 20 and more than 60 years of age.
  • Patients who don't have MRI reports

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: Spine decompression with core stability exercises
Interventions in experimental group includes Hot pack, Spinal decompression therapy and core stability exercises
Other: Spine decompression with core stability exercises
  • 50 minutes per session
  • Decompression with core stability on alternate days for 8 visits.
Experimental: Spine decompression
Intervention includesHot pack and spinal decompression therapy ..
Other: Spine decompression

40 minutes per session

-Decompression therapy on alternate days for 8 visits.

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
The Oswestry Disability Index (ODI)
Time Frame: 0 Day
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
0 Day
The Oswestry Disability Index (ODI)
Time Frame: 4th Day
The most reliable tool used by the clinicians to determine the functional disability of patients. Now days, the gold standard tool used for functional outcome of lower back is ODI.
4th Day
The Oswestry Disability Index (ODI)
Time Frame: 8th Day
The most reliable tool used by clinicians to determine the functional disability of patients. Nowadays, the gold standard tool used for the functional outcomes of the lower back is ODI.
8th Day

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric pain rating scale
Time Frame: 0 day, 4th day, 8th day
The NPRS is used as an alternative tool of VAS in which the subject responds to the intensity of pain from 0 to 10. The total number of NPRS is 0 to 10 from which zero is considered as no pain, one to three is considered as mild pain, four to six considered as moderate pain and seven up to 10 considered as severe pain. the patient is guided to score the intensity of pain from zero to ten by own self.
0 day, 4th day, 8th day
Plank test
Time Frame: 0 day, 4th day, 8th day
The test used to assess the strength of core muscles is known as plank test. It controls the endurance of the back/core stabilizing muscles. The starting position of the participants is to support the body by their elbows and forearm when off from the ground. The patient is guided to hold this position maximally. The test will be ended if the participants are unable to hold this position and time is noted by stopwatch. Total completed time will be the score to assess the core muscle strength.
0 day, 4th day, 8th day

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.
Aqua Medical Services (Pvt) Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr M.Umer Iqbal, MS, Shifa Tameer e milat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 15, 2018

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.
February 28, 2021

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.
February 28, 2021

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).
November 30, 2020

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.
January 7, 2021

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.
January 8, 2021

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.
September 5, 2021

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.
September 2, 2021

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.
September 1, 2021

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.
  • REC/-00291 M.Umer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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Conditions

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Drug Interventions

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