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
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
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
NCT ID
NCT03016676
First Posted
December 31, 2016
Last Updated
January 11, 2017
Sponsor
Lovely Professional University
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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