Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05214456
Status:
UNKNOWN
Last Update Posted:
2023-02-16
First Post:
2022-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain
Sponsor:
Iran University of Medical Sciences
Organization:
Study Overview
Official Title:
To Compare the Effect of Dry Needling Versus Lumbar Spine Mobilization on Symptoms in Patients With Chronic Nonspecific Low Back Pain
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
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:
Low back pain is a major public health challenge worldwide. The aim of this study will be to compare the effect of dry needling with mobilization on pain, functional disability, quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold using a randomized controlled trial design. pain and functional disability are primary outcomes and quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold are considered as secondary outcomes. Patients will be randomly divided into two groups: The experimental group (dry needling, sham mobilization and routine physiotherapy) and the control group (mobilization, sham dry needling and routine physiotherapy).
Detailed Description:
The present study will be a randomized, parallel group, two-arm, double-blind, double-dummy, superiority, controlled trial with a 1:1 allocation ratio. The main objective of this study is to compare the effects of dry needling and lumbar spinal mobilization on pain intensity, functional disability, lumbar multifidus and quadratus lumborum muscles function, lumbar range of motion and pain pressure threshold in patients with chronic non-specific low back pain. After selecting individuals with chronic non-specific low back pain by non-probability purposive sampling method, patients will be randomly assigned to two groups of dry needling (for lumbar Multifidus and Quadratus lumborum muscles) plus sham mobilization (first group) and lumbar spine mobilization plus sham dry needling group (second group). In addition, participants in both treatment groups will receive routine physiotherapy (including low-power laser and core stability exercise). Both groups will be treated for 8 sessions over 4 weeks. Primary outcomes include pain and functional disability, and secondary outcomes include quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold. This study is a double-blind study in which the participants, the person evaluating the outcome, and the person analyzing the data will be blinded to the allocation of patients to the two treatment groups. All of the participants will be identified and recruited by posters and word-of-mouth from the university and the surrounding local communities. Eligible participants will be explained about the aim of the study and the examination involved in this study, and all eligible patients will sign a written informed consent before entering the study. The study will be performed in the Rehabilitation Sciences school of Iran University of Medical Sciences.
Study Oversight
Has Oversight DMC:
None
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?: