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

February 15, 2023 updated by: Iran University of Medical Sciences

To Compare the Effect of Dry Needling Versus Lumbar Spine Mobilization on Symptoms in Patients With Chronic Nonspecific Low Back Pain

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Interventional group
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.
Other: Dry needling
The method of performing the dry needling technique will be based on the method presented by Dommerholt and Fernandez-de-las-Penas. The length of the needle (Tony, china) for each patient will be selected based on the size of the patient: 1) Multifidus: the patient will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. The needles will be inserted into the lumbar multifidus muscles, 1.5 to 2 cm lateral to the spinous process of all lumbar vertebrates, perpendicular to the lamina (after piercing the skin, needles are directed inferomedially). 2) Quadratus lumborum: The patient will be placed in the side lying position with the side to be treated facing up. After identifying the lateral border of the quadratus lumborum muscle, the needle will be aimed straight downward in the direction of the transverse process, followed by slight anterior, posterior, and caudal needling to explore the entire muscle.
Active Comparator: Control group
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.
Other: Mobilization
To perform Maitland's mobilization for lumbar spine, the anterior-posterior mobilization technique will be used and it is performed by pushing the heel (pisiform grip) or thumbs (thumb grip) to the vertebrae and can immediately reduce pain and restore motor function. First, the complete physical orthopedic evaluation of manual therapies will be performed using the Maitland evaluation method. Then, based on the findings of the patient evaluation, the severity, rhythm, duration and the degree of the mobilization and the place of force (spine or lamina) will be determined. To apply mobilization, the person will sleep in a prone position and the physiotherapist will use the heel of the hand or the thumbs to apply force to the first to fifth vertebrae of the lumbar spine. In segments that do not have a problem based on evaluation, first grade of the anterior-posterior Maitland's mobilization will be applied to the spinous process of the segment.
Other Names:
  • Non-thrust manipulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 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
Pain intensity measurement before intervention and 7 days after intervention
Functional disability
Time Frame: 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.
Before intervention and 7 days after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lumbar multifidus and quadratus lumborum muscles functional change
Time Frame: 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.
Before intervention and 7 days after intervention
Range of motion
Time Frame: Before intervention and 7 days after intervention
Mean Change from Baseline in Range of motion based on the measurement with tape
Before intervention and 7 days after intervention
Pain pressure threshold
Time Frame: Before intervention and 7 days after intervention
Mean Change from Baseline in Pain pressure threshold based on measurement with algometer
Before intervention and 7 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iran University of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hamide Mirzaie, MSc student, Iran University of Medical Sciences
  • Study Director: Mohammadreza Pourahmadi, PhD, Iran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IR. IUMS.REC.1400.651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets of this study will be available on a reasonable request to the corresponding author.

IPD Sharing Time Frame

starting 6 months after the publication

IPD Sharing Access Criteria

The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders. The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Applicants can contact hamide mirzaie by Email. Email address: hamide.mirzaie@yahoo.com. Applicants should explain their project and how the data/documents of this study will be used in their project in detail. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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