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

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ClinicalTrials.gov Identifier: NCT03016676
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kanchan Sarker, Lovely Professional University

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.

Condition or disease Intervention/treatment Phase
Chronic Non Specific Low Back Pain Other: Spinal Manipulation Other: Exercise therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016676


Sponsors and Collaborators
Lovely Professional University
Investigators
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Principal Investigator: Kanchan Ku Sarker, Ph.D Lovely Professional University,Phagwara, Kapurthala, Punjab, India.
Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

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Responsible Party: Kanchan Sarker, PhD Research Scholar, Lovely Professional University
ClinicalTrials.gov Identifier: NCT03016676    
Other Study ID Numbers: LPU-11304873
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kanchan Sarker, Lovely Professional University:
Spinal Manipulation
Postural Instability
Quality of Life
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations