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

Primary Purpose

Chronic Non Specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Spinal Manipulation
Exercise therapy
Sponsored by
Lovely Professional University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Non Specific Low Back Pain focused on measuring Spinal Manipulation, Postural Instability, Quality of Life

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Spinal manipulation

    Exercise therapy

    Arm Description

    Spinal manipulation -High velocity low amplitude thrust (HVLA), Dosages : 2 repetition at the same time, Duration-10-20 minutes. total 2 weeks.

    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.

    Outcomes

    Primary Outcome Measures

    Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.
    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.
    Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.
    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.
    Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 31, 2016
    Last Updated
    January 11, 2017
    Sponsor
    Lovely Professional University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03016676
    Brief Title
    Efficacy of SM on Postural Instability and Quality of Life in Patients With Chronic Non Specific Low Back Pain(CNSLBP)
    Official Title
    Study of Spinal Manipulation(SM) Decrease Postural Instability and Improve Quality of Life in Patients With Chronic Non Specific Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Lovely Professional University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Non Specific Low Back Pain
    Keywords
    Spinal Manipulation, Postural Instability, Quality of Life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Spinal manipulation
    Arm Type
    Experimental
    Arm Description
    Spinal manipulation -High velocity low amplitude thrust (HVLA), Dosages : 2 repetition at the same time, Duration-10-20 minutes. total 2 weeks.
    Arm Title
    Exercise therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Spinal Manipulation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise therapy
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.
    Description
    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.
    Time Frame
    Baseline before treatment and after 2 week of treatment
    Title
    Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.
    Description
    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.
    Time Frame
    Baseline before treatment and after 2 week of treatment
    Title
    Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.
    Description
    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.
    Time Frame
    Baseline before treatment and after 2 week of treatment
    Title
    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.
    Description
    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.
    Time Frame
    Baseline before treatment and treatment after 2 week of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kanchan Ku Sarker, Ph.D
    Organizational Affiliation
    Lovely Professional University,Phagwara, Kapurthala, Punjab, India.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    http://www.ijpbs.net/abstract.php?article=5240
    Description
    Kanchan Sarker, U K Mohanty, Jasobanta Sethi, <em><a href="http://citeweb.info/20160278206">EFFECT OF SPINAL MANIPULATION ON POSTURAL INSTABILITY IN PATIENTS WITH NON SPECIFIC LOW BACK PAIN</a></em> (2016)
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://www.ijpbs.net/abstract.php?article=5240

    Learn more about this trial

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

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