Clinical trial NCT03016676: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non Specific Low Back Pain
Keywords: Spinal Manipulation
Postural Instability
Quality of Life
Lead sponsor: Lovely Professional University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Patients with CNSLBP will received SM and ET to measure postural instability to assess after 12 session over 2 weeks.
timeFrame: Baseline before treatment and after 2 week of treatment
measure: Patients with CNSLBP will be received SM and ET to measure quality of life to assess after 12 session over 2 weeks.
timeFrame: Baseline before treatment and after 2 week of treatment
measure: Patients with CNSLBP will be received SM and ET to measure Pain intensity to assess after 12 session over 2 weeks.
timeFrame: Baseline before treatment and after 2 week of treatment
measure: 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.
timeFrame: Baseline before treatment and treatment after 2 week of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Lovely Professional University,Phagwara, Kapurthala, Punjab, India.
name: Kanchan Ku Sarker, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: