Viewing Study NCT02883634


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Study NCT ID: NCT02883634
Status: COMPLETED
Last Update Posted: 2019-09-26
First Post: 2016-08-25
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Specific or Non-Specific Manipulation for Patients With Back Pain
Sponsor: Universidade Cidade de Sao Paulo
Organization:

Study Overview

Official Title: Short, Medium and Long Term Effects of Specific and Nonspecific Spinal Manipulative Therapy in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2019-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: We aim to evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.
Detailed Description: To evaluate the long-term effects of 10 sessions of spinal manipulative therapy applied in a vertebral region-specific or region nonspecific level immediately after treatment and 3 and 6 months after randomization.

148 patients with chronic non-specific low back pain will be enrolled for this clinical trial. Patients will undergo to a specific physical examination in order to determine the ideal lumbar spine level to be manipulated. The outcomes of interest are pain intensity, pain pressure threshold, global perceived effect and disability associated with back pain. After the first assessment patients will be randomly assigned to two groups that will receive 10 sessions of spinal manipulation over a period of four weeks, and may receive manipulation according to the findings on physical examination (specific manipulation) or may receive manipulation in the upper thoracic region, disregarding the physical examination findings (nonspecific manipulation).

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: