The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain

Not Applicable

Recruiting

• Conditions: Low Back Pain
• Interventions: Other: Dry needling; Other: Mobilization

• Registration Number: NCT05214456
• Lead Sponsor: Iran University of Medical Sciences

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 Timeline

• Study First Submitted: 2022-01-15
• Study First Submitted QC: 2022-01-15
• Study First Posted: 2022-01-28
• Study Start: 2022-10-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	Dry needling	The interventional group will comprise 28 participants with chronic non-specific low back pain. The treatments of this group will include dry needling plus sham mobilization for the lumbar spine and routine physiotherapy. The needles will be inserted to obtain local twitch responses, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes. Sham mobilization for the lumbar spine will be done in the same way as the real mobilization, with the difference that the mobilization will be applied only on the skin surface and less than the first degree of Maitland's mobilization. Routine physical therapy will include low-level laser therapy and motor control training. The treatment will last 4 weeks, 8 sessions, twice a week.
Control group	Mobilization	The control group will comprise 28 participants with chronic non-specific low back pain. The treatments of this group will include anterior-posterior mobilization based on the Maitland technique for the lumbar spine plus sham dry needling and routine physiotherapy. Based on the findings of the patient evaluation, the severity, rhythm, time, the degree of mobilization and the place of force (spine or lamina) will be determined. For sham dry needling The needles will be inserted subcutaneously and there will be no local twitch response. Then the needles will be left in place for 20 minutes. Routine physical therapy will include low-level laser therapy and motor control training. The treatment will last 4 weeks, 8 sessions, twice a week.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Pain intensity measurement before intervention and 7 days after intervention	Mean Change from Baseline in Pain Scores on the Numerical Pain Rating Scale (0 means no pain and 100 means the most imaginable pain).; 9
Functional disability	Before intervention and 7 days after intervention	Mean Change from Baseline in Functional disability Scores based on Oswestry Disability Index. 0% to 20% indicate minimal disability, 21% to 40% indicate moderate disability, 41%-60% indicates severe disability, 61%-80% means crippled and 81%-100% indicates that the patient is either bed-bound or exaggerating his/her symptoms. The validity and the reliability of the Persian version of this questionnaire has been shown in the previous studies.

Secondary Outcome Measures

Name	Time	Method
Lumbar multifidus and quadratus lumborum muscles functional change	Before intervention and 7 days after intervention	Mean Change from Baseline in Lumbar multifidus and quadratus lumborum muscles Functional changes based on the measurement of thickness changes between rest and contraction status of these muscles by using ultrasound.
Range of motion	Before intervention and 7 days after intervention	Mean Change from Baseline in Range of motion based on the measurement with tape
Pain pressure threshold	Before intervention and 7 days after intervention	Mean Change from Baseline in Pain pressure threshold based on measurement with algometer

Trial Locations

Locations (1)

IRANums; 🇮🇷 Tehran, Iran, Islamic Republic of