Clinical trial NCT05214456: The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain
Official title: To Compare the Effect of Dry Needling Versus Lumbar Spine Mobilization on Symptoms in Patients With Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain, dry needling, mobilization, pain pressure threshold, muscle function
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Participants aged between 18 to 45 years.
* Moderate pain intensity (between 30 to 60) based on Numerical Pain Rating Scale (0 means no pain and 100 is the most imaginable pain).
* Participants with trigger points in the quadratus lumborum and lumbar multifidus muscles.
* The Participant's symptoms are provoked with passive accessory intervertebral movements on at least one level of the lumbar spine vertebrae.
* Patients are able to read and write Persian.

Exclusion Criteria:

* Complications that affect the treatment process such as systemic diseases, neurological disorders, inflammatory conditions, infectious conditions, structural and degenerative changes, metabolic bone diseases and bleeding disorders.
* History of lumbar surgery.
* Specific low back pain (Neurogenic low back pain, spinal stenosis, cauda equina syndrome, spondylolisthesis, and Presence of any signs or symptoms of non- musculoskeletal pathology e.g. cancer, infection and fracture based on paraclinical findings)
* Inability to obtain prone lying.
* Pregnancy.
* Needle phobia.
* Long history of steroid use

Primary outcomes:
measure: Pain intensity
timeFrame: Pain intensity measurement before intervention and 7 days after intervention
measure: Functional disability
timeFrame: Before intervention and 7 days after intervention
Secondary outcomes:
measure: Lumbar multifidus and quadratus lumborum muscles functional change
timeFrame: Before intervention and 7 days after intervention
measure: Range of motion
timeFrame: Before intervention and 7 days after intervention
measure: Pain pressure threshold
timeFrame: Before intervention and 7 days after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: IRANums
Study officials:
affiliation: Iran University of Medical Sciences
name: Hamide Mirzaie, MSc student
role: PRINCIPAL_INVESTIGATOR
affiliation: Iran University of Medical Sciences
name: Mohammadreza Pourahmadi, PhD
role: STUDY_DIRECTOR
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