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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Dry needling
Mobilization
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, dry needling, mobilization, pain pressure threshold, muscle function

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRANumsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain intensity
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
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

Lumbar multifidus and quadratus lumborum muscles functional change
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
Mean Change from Baseline in Range of motion based on the measurement with tape
Pain pressure threshold
Mean Change from Baseline in Pain pressure threshold based on measurement with algometer

Full Information

First Posted
January 15, 2022
Last Updated
February 15, 2023
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05214456
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, dry needling, mobilization, pain pressure threshold, muscle function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mobilization
Other Intervention Name(s)
Non-thrust manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
Pain intensity measurement before intervention and 7 days after intervention
Title
Functional disability
Description
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.
Time Frame
Before intervention and 7 days after intervention
Secondary Outcome Measure Information:
Title
Lumbar multifidus and quadratus lumborum muscles functional change
Description
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.
Time Frame
Before intervention and 7 days after intervention
Title
Range of motion
Description
Mean Change from Baseline in Range of motion based on the measurement with tape
Time Frame
Before intervention and 7 days after intervention
Title
Pain pressure threshold
Description
Mean Change from Baseline in Pain pressure threshold based on measurement with algometer
Time Frame
Before intervention and 7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamide Mirzaie, MSc student
Phone
00989335785767
Email
hamide.mirzaie@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammadreza Pourahmadi, PhD
Phone
00989122245593
Email
pourahmadi.m@iums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamide Mirzaie, MSc student
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammadreza Pourahmadi, PhD
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
IRANums
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamide Mirzaie, M.Sc candidate
Phone
00989134146786
Email
hamide.mirzaie@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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The Effect of Dry Needling Compared to Lumbar Spine Mobilization in Patients With Chronic Non Specific Low Back Pain

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