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

NCT03016676 | Completed DMC

• 1 other identifier: LPU-11304873
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Non Specific Low Back Pain

Keywords

Spinal Manipulation; Postural Instability; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

Study Arms (2)

Spinal manipulation

EXPERIMENTAL

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

Exercise therapy

EXPERIMENTAL

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

Interventions

Spinal Manipulation OTHER

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.

Spinal manipulation

Exercise therapy OTHER

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).

Exercise therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lovely Professional University: lead

Related Links

• 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)

MeSH Terms

Interventions

Manipulation, Spinal; Exercise Therapy

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Kanchan Ku Sarker, Ph.D

  Lovely Professional University,Phagwara, Kapurthala, Punjab, India.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Scholar

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 10, 2017
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share