A clinical study to see relationship between lower spine movement with legpain and back pain in lumbar disc prolapse patients

Completed

• Conditions: Lumbar Disc Diseases

• Registration Number: CTRI/2014/09/004950
• Lead Sponsor: Stavya Spine Hospital and Research Institute

Brief Summary

This is a single centre,prospective,observational study. Patients will be evaluated in single OPD visit over time to obtain target 200 number of patients. A total minimum of two hundred (200) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Patients will be evaluated clinically and using X-ray radiographs, MRI in supine lying position. The total duration of this study is expected to be upto six to twelve ( 6 - 12 ) months.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-09
• Study Completion: 2018-03-11
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients are included in the study if all of the following criteria are met: 1.Patients having single level disc disease (L4/5 or L5 S1): Degenerative/ Disc prolapse 2.Patients having Supine lying pain (LBP/ leg pain/ discomfort/ numbness).
• 3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to scheduled visits, treatment plan, completing forms, and other study procedures; 4.Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
• 5.Male or Female,having age between 35-70 yrs.

Exclusion Criteria

• Patients are excluded from participating in this study if any of the following criteria are met: 1.Has had previous surgery at the index level; 2.Has a fused level adjacent to the index level; 3.Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH); 4.Active systemic or local infection; 5.Known or documented history of communicable disease, including AIDS or HIV; 6.Active hepatitis (receiving medical treatment within two years); 7.Active rheumatoid arthritis, non-controlled diabetes mellitus.
• 8.Immunologically suppressed, history of Paget’s disease, osteomalacia, or any other metabolic bone disease; 9.Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight; 10.Active malignancy.
• A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years; 11.Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol); 12.Pregnant or planning to become pregnant during study period; 13.Patients who are incarcerated.
• 14.Patients who have limited life expectancy due to significant medical comorbidities.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Association of supine lying low back pain/leg pain with retrolisthesis	1st Day Assessment

Trial Locations

Locations (1)

Stavya Spine Hospital and Research Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Stavya Spine Hospital and Research Institute

🇮🇳Ahmadabad, GUJARAT, India

Dr Bharat R Dave

Principal investigator

07926568174

brd_172@yahoo.com