Efficacy of SM on Postural Instability and Quality of Life in Patients With Chronic Non Specific Low Back Pain(CNSLBP)

January 11, 2017 updated by: Kanchan Sarker, Lovely Professional University

Study of Spinal Manipulation(SM) Decrease Postural Instability and Improve Quality of Life in Patients With Chronic Non Specific Low Back Pain

This study will give a new insight to the physiotherapy fraternity in the effects of spinal manipulation in as clinical practice, as well as the patient's community in quick re-establishment of functional ability, pain decrease, and improvement of quality of life for economic reasons. In this high opinion, application of short-term intensive spinal manipulation for non specific chronic low back pain treatment is desirable.

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

The protocol for group A included High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae.The HVLA thrust will be performed with the patient side lying in a neutral.52 They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.

The protocol for group B included sets of exercise therapy. There are three components to the exercise therapy (ET) program: self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's manage their LBP and prevent future LBP recurrences. Total number of visits 12 (e.g., ability to perform exercises independently).

Outcome:

Patient self-report outcomes will be collected at first baseline visit and its base on the pain intensity and quality of life will be assessed by using numerical pain rating scale and EuroQol questionnaire. Objective outcome measures will be collected at the first baseline visit and its base on postural instability and pressure pain threshold will be assessed by using Win track platform and digital algometer.

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.
200

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

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 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 55 years of age.
  • Both genders.
  • Subjects diagnosed with non-specific chronic low back pain with duration of >3 months.
  • Low back pain intensity≥3 on 0-10 in numerical pain rating scale.

Exclusion Criteria:

  • Injury or surgery of spine.
  • Congenital spinal deformity (e.g Spina bifida, Scoliosis, ankylosing spondylitis etc )
  • Lumbar radiculopathy or presenting neurological deficit.
  • Subjects administered Epidural injection.
  • Contra-indication to manipulations-vertebral malignancy, vertebral-basilar insufficiency, bone infections, 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: 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: Spinal manipulation
Spinal manipulation -High velocity low amplitude thrust (HVLA), Dosages : 2 repetition at the same time, Duration-10-20 minutes. total 2 weeks.
Other: Spinal Manipulation
High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae. The exact level thrust will be at the discretion of the treating practitioner determined by the level with the greatest perceivable motion restriction. The HVLA thrust will be performed with the patient side lying in a neutral.They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.
Experimental: Exercise therapy
Exercise Therapy(ET): Exercise therapy (ET) 3 program: self education, supervised exercise visits, and home exercise. Duration-45 minutes,Total number of visits 12 for 2 weeks.
Other: Exercise therapy
Self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's mange their LBP and prevent future LBP recurrences. Total number of visits 12.Each visit starts with 10 minutes of self-care education to help patients establish and monitor goals aligned with the exercise program and enhance their understanding of LBP. Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).

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
Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.
Time Frame: Baseline before treatment and after 2 week of treatment
Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study,Change from baseline in postural instability will be measured by Win Track Platform at 2 weeks.
Baseline before treatment and after 2 week of treatment
Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.
Time Frame: Baseline before treatment and after 2 week of treatment
Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in quality of life on EuroQoL questionnaire at 2 weeks.EuroQol questionnaire is a wide accepted questionnaire for health-related quality of life and consists of two components. Its first component (EQ-5D-5L) consists of five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression). However, each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Baseline before treatment and after 2 week of treatment
Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.
Time Frame: Baseline before treatment and after 2 week of treatment
Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain instability on Numerical pain rating scale (NPRS). An11-point numeric pain rating scale will be used to assess pain intensity (primary outcome measure), with 0 representing "no pain" and 10 representing the "worst possible pain" at the time of the assessment. Pain intensity will be measured before and after treatment.
Baseline before treatment and after 2 week of treatment
Patients with CNSLBP will be received SM and ET to measure Pain sensitivity(Pressure pain threshold-PPT) to assess after 12 session over 2 weeks.
Time Frame: Baseline before treatment and treatment after 2 week of treatment
Clinical outcomes will be assessed at baseline and following 2 weeks of participation in the study, Change from baseline in pain sensitivity (PPT) on Digital algometer.Pain sensitivity (PPT) will be measured on the lumbar area bilaterally. Digital Algometer (Jagson scientific Industries, Ambala-133001, Haryana, India) will be used with a circular rounded aluminium tip, 1 cm2, and with an application rate of 25 KN/s. The measurements will be performed twice and the average of the two registrations will be filed.
Baseline before treatment and treatment after 2 week of treatment

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.
Lovely Professional University

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: Kanchan Ku Sarker, Ph.D, Lovely Professional University,Phagwara, Kapurthala, Punjab, India.

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.

Helpful Links

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

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.
July 1, 2015

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.
September 1, 2016

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.
November 1, 2016

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).
December 31, 2016

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, 2017

First Posted (Estimate)

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 10, 2017

Study Record Updates

Last Update Posted (Estimate)

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.
January 12, 2017

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.
January 11, 2017

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.
January 1, 2017

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.
  • LPU-11304873

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

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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