search
Back to results

Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Placebo dry needling
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring lower back pain, dry needling, ultrasound, disability

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Nonspecific pain in the lumbar region.

Exclusion Criteria:

  • Previous surgery in the lumbosacral spine.
  • Osteoporosis.
  • Needle phobia.
  • Neurogenic pain with positive tests or negative symptoms.
  • Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases.
  • Pregnancy.
  • Physiotherapy intervention in the 4 weeks prior to the intervention.

Sites / Locations

  • Sebastian

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Placebo dry needling

Dry needling

Outcomes

Primary Outcome Measures

Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
This scale shows concurrent and predictive validity in the assessment of pain. A difference of 2 points represents a clinically significant change that exceeds the limits of measurement error.

Secondary Outcome Measures

Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters
Histograms using image analysis
Pressure Pain threshold
It will be measured by using a pressure algometer. Lumbar multifidus algometry is performed approximately 1.5 cm from the spinous process of the level to be evaluated. The measurement will be taken 3 times to avoid variability by instructing patients to say verbally when they begin to feel pain.
Disability
it will be measured using the Roland-Morris questionnaire. Values range from 0 (absence of disability) to 24 (maximum level of disability).
Contraction time measured in milliseconds with M-mode
The patient performs a hip extension in the prone position

Full Information

First Posted
September 14, 2021
Last Updated
November 20, 2021
Sponsor
University of Alcala
search

1. Study Identification

Unique Protocol Identification Number
NCT05067673
Brief Title
Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.
Official Title
Association Between Tissue Changes in Lumbar Multifidae and Improvement in Pain and Disability After Dry Needling in Subjects With Nonspecific Low Back Pain. Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 8, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

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

5. Study Description

Brief Summary
Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.
Detailed Description
Lower back pain in regarded as the main cause of disability in the world, which has a significant socio-economic impact. Deep dry needling is effective in handling such pain and is one of the techniques of choice by physiotherapists. In this area, the use of ultrasound provides information of interest such as length, thickness, diameter, cross-sectional area or muscle volume, among others. Objective: Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability. It's a double-blind randomized clinical trial in parallel groups. Patients will be randomly divided into 2 groups. One of them will receive dry needling and the other dry needling placebo. The initial, post-needling and a week after evaluations will be performed by a blinded to the intervention therapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
lower back pain, dry needling, ultrasound, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind randomized clinical trial in parallel groups
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo dry needling
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Dry needling
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
The dry needling will be performed using disposable stainless steel needles (AGU-PUNT needles of size 0.30x50mm or 0.30x60mm depending on the patient) that will be inserted perpendicularly at the point of major hyperalgesia using the Hong technique. The patient will be in the prone position with a pillow placed in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. After this time, the needle will be inserted at the point indicated by the evaluator before reaching the lumbar multifidus by means of echolocation. Once it is assured that it is in the right place, a total of 10 repetitions are performed. The needle will be removed by depositing it in a needle container and a compression will be removed in the treated area until hemostasis is achieved.
Intervention Type
Other
Intervention Name(s)
Placebo dry needling
Intervention Description
Placebo dry needling will be performed with DongBang DB100 Acupuncture Needles which, upon contact with the patient, retract, hiding in the needle handle. The patient will be in the prone position with a pillow in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. At the point indicated by the evaluator, the placebo needle will be placed initially and the introduction of the needle and its location will be simulated with the ultrasound system. 10 repetitions will be performed. The needle will be removed by depositing it in a needle container and a compression will be made in the treated area.
Primary Outcome Measure Information:
Title
Changes from baseline in pain on the 10-point Visual Analog Scale (VAS, 0-10 score) at immediatelypost-needling and a week after.
Description
This scale shows concurrent and predictive validity in the assessment of pain. A difference of 2 points represents a clinically significant change that exceeds the limits of measurement error.
Time Frame
Baseline, immediately post-needling and a week after.
Secondary Outcome Measure Information:
Title
Thickness of lumbar multifidus measured with Rehabilitive Ultrasound Imaging in millimeters
Time Frame
Baseline, immediately post-needling and a week after.
Title
Histograms using image analysis
Time Frame
Baseline, immediately post-needling and a week after.
Title
Pressure Pain threshold
Description
It will be measured by using a pressure algometer. Lumbar multifidus algometry is performed approximately 1.5 cm from the spinous process of the level to be evaluated. The measurement will be taken 3 times to avoid variability by instructing patients to say verbally when they begin to feel pain.
Time Frame
Baseline, immediately post-needling and a week after.
Title
Disability
Description
it will be measured using the Roland-Morris questionnaire. Values range from 0 (absence of disability) to 24 (maximum level of disability).
Time Frame
Baseline, immediately post-needling and a week after.
Title
Contraction time measured in milliseconds with M-mode
Description
The patient performs a hip extension in the prone position
Time Frame
Baseline, immediately post-needling and a week after.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years. Nonspecific pain in the lumbar region. Exclusion Criteria: Previous surgery in the lumbosacral spine. Osteoporosis. Needle phobia. Neurogenic pain with positive tests or negative symptoms. Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases. Pregnancy. Physiotherapy intervention in the 4 weeks prior to the intervention.
Facility Information:
Facility Name
Sebastian
City
Torrejón De Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.

We'll reach out to this number within 24 hrs