Structured Systematic Exercise Program for Subjects with Chronic Lumbar Disc Herniation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1.Physical activity measurement.
Study Overview
Brief Summary
| Aims and Objective of the study |
Aim: To determine the effectiveness of structured systematic exercise program on level of physical activity for subjects with chronic lumbar disc herniation.
Objectives:
1. To evaluate the level of Physical activity among subjects with chronic lumbar disc herniation.
2. To establish a structured systematic exercise program on Physical activity for subjects with chronic lumbar disc herniation.
3. To evaluate the rate of compliance of developed structured systematic exercise program for improving Physical activity in subjects with chronic lumbar disc herniation.
4. To evaluate the effect of structured systematic exercise program on Physical activity in subjects with chronic lumbar disc herniation.
METHODOLOGY OF THE STUDY CONDUCTED IN FOUR PHASES OR PARTS
Part-1 of the study consists of evaluation of Physical activity level among chronic lumbar disc herniation.
The level of Physical activity will be measured using accelerometer and IPAQ Short Form (International Physical Activity Questionnaire).
**Part-2 Establishing structured/therapeutic program on Physical activity for subjects with chronic lumbar disc herniation.**A systematic review on therapeutic programs or physiotherapy interventions for
Physical Activity in chronic disc herniation will be conducted. Based on the systematic review a therapeutic program will be established.
| The standardization and validation of therapeutic program will be carried by Delphi survey to establish consensus opinion among 30 subject experts physiotherapist who having experience in using exercise to treat people with Chronic lumbar disc herniation. |
An electronic questionnaire by Google form will be used to collect experts opinions. Consensus will be defined as when 70% of the experts agreed or disagreed with an item. The strength of agreement or disagreement will be evaluated through grading of responses with a Likert response scale. Likert response scale questions. The number of responses of “strongly agree,†“agree,†or “somewhat agree†will be summated and expressed as a percentage of agreement. Similarly, the number of responses of “strongly disagree,†“disagree,†or “somewhat disagree†will be summated and expressed as a percentage of disagreement.
Part-3 Evaluating the Rate of compliance of developed Structured program on Physical activity in chronic disc herniation.
A study will be conducted to find the rate of compliance to types, intensity of exercises. The study will be designed with an objective to measures the rate of compliance of established structured exercise program.
Part-4 Evaluation of effect of Structured/therapeutic program on Physical activity in chronic disc herniation.
Screening will be done on the basis of inclusion and exclusion criteria for both the groups. The eligible patient will be allotted into group A and B by Block Randomisation.
Group A (Experimental group): The treatment group will undergo Structured/therapeutic program for duration 6 weeks of intervention.
Group B (Control group): The control group will undergo conventional exercises for duration 6 weeks of intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 50.00 Year(s) (—)
Inclusion Criteria
- •Age group between 30 to 50 years.
- •Gender- both male and female.
- •Subjects referred by Orthopaedic surgeons, and neurosurgeons who initially have diagnosed the pathological condition involvement of LDH at the level of L4-L5, L5-S1, or L4-L5+L5-S1 based on correlation with MRI.
- •Chronic Lumbar disc herniation pain with duration of more than 3 months of onset.
- •Lower back pain without referred pain to limbs or with referred pain to the legs/buttock region, or manifest as a combination of both.
- •Clinical factors at baseline with any of the findings: a.
- •Visual Analog scale legs/buttock region pain less than 7.
- •Visual Analog scale back pain less than 7.0, c.
- •Oswestry Disability Index score of at least 30 out of 100 points, d.
- •Positive straight leg rises above 60 degree.
Exclusion Criteria
- •Subjects with having neurological impairments (red flags signs) like Muscle weakness, loss of sensation, impaired reflexes, Cauda equina syndrome or progressive motor deficit.
- •Subjects with history of having fracture of lumbar spine or Spondylolisthesis.
- •Subjects having spinal tumour or malignancy or TB in their spine.
- •Subjects with history lumbar spine surgery.
- •Subjects having spinal deformity like Scoliosis, Kyphosis or Spina bifida etc.
- •Subjects with Neurogenic claudication reduced walking distance and neurologic signs.
- •Subjects with neuropathic pain, shows positive tests of hypersensitivity to non-noxious (allodynia) and noxious stimuli (hyperalgesia).
- •Subjects with Inflammatory disease, Vestibular condition.
- •Subjects present with any Musculoskeletal condition that limit mobility like severe arthritis, trauma, fracture, surgery etc
- •Subjects who are unwilling to participate.
Outcomes
Primary Outcomes
1.Physical activity measurement.
Time Frame: Baseline and after 6 weeks of intervention.
Secondary Outcomes
- 2.Low back pain intensity will be measured using visual analogue scale(3.Mobility: Neural tension using straight-leg-raising test in degrees & Lumbo-pelvic-hip complex motion using in centimetre.)
Investigators
Vinod Babu K
Padmashree Institute of Physiotherapy