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Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound- guided Percutaneous Neuromulation
TENS Therapy
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Neuromodulation, Low back pain, Ultrasound-guied percutaneous, TENS, Randomized Controlled Trial, Percutaneous stimulation

Eligibility Criteria

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

Inclusion Criteria:

  • Score ≥4 on the Roland Morris Disability Questionnaire.
  • Low back pain for ≥3 months
  • Age between 18 and 65 years
  • Not undergoing another physical therapy treatment

Exclusion Criteria:

  • Presence of lumbar stenosis
  • Diagnosis of spondylolisthesis
  • Diagnosis of fibromyalgia
  • Treatment with corticosteroid or oral medication within the past two weeks
  • A history of spinal surgery
  • Contraindication of analgesic electrical therapy
  • Having previously received a treatment of electrical analgesia.

Sites / Locations

  • Adelaida María Castro-SánchezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasound-guided Percutaneous Neuromodulation

TENS therapy

Arm Description

This group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L3 (1 times/ 4 weeks).

The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region (1 times/ 4 weeks).

Outcomes

Primary Outcome Measures

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
This is a self-reported questionnaire consisting in 24 ítems reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

Secondary Outcome Measures

Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points.
Change from baseline in pain intensity (Visual Analogue Scale).
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
It is a 17-item questionnaire that measures the fear of movement and (re)injury
Change from baseline on Quality of Life.
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Change from Mcquade Test
It measures the isometric endurance of trunk flexion muscles
Change from baseline in lumbar mobility flexion
It is determined by measuring the finger-to-floor distance
Change from baseline in range of motion and lumbar segmental mobility
This variable is quantified using the SpinalMouse® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagital spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.

Full Information

First Posted
October 20, 2018
Last Updated
September 20, 2023
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT03738748
Brief Title
Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.
Official Title
Effectiveness of the Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

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
The study evaluates the effectiveness of Ultrasound-guided Percutaneous Neuromodulation in the lumbar multifidus of L3 in non-specific chronic low back pain.
Detailed Description
The effectiveness of neuromoduation in analgesic therapies has been more than contrasted. Considering that multifidus muscles, composed of the spinous transverse rotators muscles and spinous transverse multifidus muscles, are fundamental both for the static and for the dynamics of the lumbar spine, particularly for the region of L-3, the treatment of this musculature with ultrasound-guided percutaneous neuromodulation in patients with nonspecific chronic low back pain must have an analgesic repercussion in this nociceptive process. Therefore, given that neuromodulation has been considered as a more than effective treatment in painful symptomatology and that diverse scientific literature has proven the activity of the multifida musculature directly affects the stability and mobility of the lumbar spine, it is more than likely interventions with neuromodulative treatments in the multifidus musculature at the level of the third lumbar vertebrae have positive results in Non-specific Chronic Low Back Pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Neuromodulation, Low back pain, Ultrasound-guied percutaneous, TENS, Randomized Controlled Trial, Percutaneous stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided Percutaneous Neuromodulation
Arm Type
Experimental
Arm Description
This group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L3 (1 times/ 4 weeks).
Arm Title
TENS therapy
Arm Type
Active Comparator
Arm Description
The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region (1 times/ 4 weeks).
Intervention Type
Other
Intervention Name(s)
Ultrasound- guided Percutaneous Neuromulation
Intervention Description
The experimental group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L-3, once a week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
TENS Therapy
Intervention Description
The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region, once a week for 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Description
This is a self-reported questionnaire consisting in 24 ítems reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Secondary Outcome Measure Information:
Title
Change from baseline in disability. Oswestry Low Back Pain Disability Index (ODI).
Description
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points.
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from baseline in pain intensity (Visual Analogue Scale).
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain.
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Description
It is a 17-item questionnaire that measures the fear of movement and (re)injury
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from baseline on Quality of Life.
Description
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from Mcquade Test
Description
It measures the isometric endurance of trunk flexion muscles
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from baseline in lumbar mobility flexion
Description
It is determined by measuring the finger-to-floor distance
Time Frame
At baseline and at 4 weeks (immediate post-treatment)
Title
Change from baseline in range of motion and lumbar segmental mobility
Description
This variable is quantified using the SpinalMouse® device (Phisiotech, Spain). It is an electronic computer-aided measuring device that measures sagital spinal amplitude of movement (ROM) and intersegmental angles in a non-invasive way.
Time Frame
At baseline and at 4 weeks (immediate post-treatment)

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: Score ≥4 on the Roland Morris Disability Questionnaire. Low back pain for ≥3 months Age between 18 and 65 years Not undergoing another physical therapy treatment Exclusion Criteria: Presence of lumbar stenosis Diagnosis of spondylolisthesis Diagnosis of fibromyalgia Treatment with corticosteroid or oral medication within the past two weeks A history of spinal surgery Contraindication of analgesic electrical therapy Having previously received a treatment of electrical analgesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adelaida María Castro-Sánchez, PhD
Phone
+34950214576
Ext
+34950214576
Email
adelaid@ual.es
First Name & Middle Initial & Last Name or Official Title & Degree
Adelaida Castro-Sánchez, PhD
Phone
+34689723203
Email
adelaid@ual.es
Facility Information:
Facility Name
Adelaida María Castro-Sánchez
City
Almería
ZIP/Postal Code
04120
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
28456669
Citation
Goubert D, De Pauw R, Meeus M, Willems T, Cagnie B, Schouppe S, Van Oosterwijck J, Dhondt E, Danneels L. Lumbar muscle structure and function in chronic versus recurrent low back pain: a cross-sectional study. Spine J. 2017 Sep;17(9):1285-1296. doi: 10.1016/j.spinee.2017.04.025. Epub 2017 Apr 26.
Results Reference
background
PubMed Identifier
20193941
Citation
Freeman MD, Woodham MA, Woodham AW. The role of the lumbar multifidus in chronic low back pain: a review. PM R. 2010 Feb;2(2):142-6; quiz 1 p following 167. doi: 10.1016/j.pmrj.2009.11.006.
Results Reference
background
PubMed Identifier
28062862
Citation
Rajfur J, Pasternok M, Rajfur K, Walewicz K, Fras B, Bolach B, Dymarek R, Rosinczuk J, Halski T, Taradaj J. Efficacy of Selected Electrical Therapies on Chronic Low Back Pain: A Comparative Clinical Pilot Study. Med Sci Monit. 2017 Jan 7;23:85-100. doi: 10.12659/msm.899461.
Results Reference
background
PubMed Identifier
27075679
Citation
Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. Erratum In: Orthopade. 2016 Jul;45(7):627. German.
Results Reference
background
PubMed Identifier
19027343
Citation
Wallwork TL, Stanton WR, Freke M, Hides JA. The effect of chronic low back pain on size and contraction of the lumbar multifidus muscle. Man Ther. 2009 Oct;14(5):496-500. doi: 10.1016/j.math.2008.09.006. Epub 2008 Nov 21.
Results Reference
background
PubMed Identifier
18349481
Citation
Hides JA, Stanton WR, McMahon S, Sims K, Richardson CA. Effect of stabilization training on multifidus muscle cross-sectional area among young elite cricketers with low back pain. J Orthop Sports Phys Ther. 2008 Mar;38(3):101-8. doi: 10.2519/jospt.2008.2658. Epub 2007 Dec 7.
Results Reference
background
PubMed Identifier
1188084
Citation
Kirby CC. A look at radiologic technology education. Radiol Technol. 1975 Sep-Oct;47(2):82-9.
Results Reference
background
PubMed Identifier
30311692
Citation
Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
Results Reference
background
PubMed Identifier
30302288
Citation
Nayak R, Banik RK. Current Innovations in Peripheral Nerve Stimulation. Pain Res Treat. 2018 Sep 13;2018:9091216. doi: 10.1155/2018/9091216. eCollection 2018.
Results Reference
background
PubMed Identifier
29905630
Citation
Ilfeld BM, Gabriel RA, Said ET, Monahan AM, Sztain JF, Abramson WB, Khatibi B, Finneran JJ 4th, Jaeger PT, Schwartz AK, Ahmed SS. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study. Reg Anesth Pain Med. 2018 Aug;43(6):580-589. doi: 10.1097/AAP.0000000000000819.
Results Reference
background
PubMed Identifier
30160335
Citation
Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
Results Reference
background
PubMed Identifier
21971895
Citation
Facci LM, Nowotny JP, Tormem F, Trevisani VF. Effects of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) in patients with nonspecific chronic low back pain: randomized clinical trial. Sao Paulo Med J. 2011;129(4):206-16. doi: 10.1590/s1516-31802011000400003.
Results Reference
background
PubMed Identifier
25122629
Citation
Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.
Results Reference
background
PubMed Identifier
21992165
Citation
Gofeld M. Ultrasound-guided caudad epidural access for the lumbosacral neurostimulation: case report and technical note. Neuromodulation. 2011 Jan;14(1):68-71; discussion 71. doi: 10.1111/j.1525-1403.2010.00297.x. Epub 2010 Oct 7.
Results Reference
background
Links:
URL
http://dx.doi.org/10.4321/S1134-80462015000300006
Description
Neuromodulación eléctrica y dolor raquídeo.
URL
https://doi.org/10.1016/j.pain.2007.07.028
Description
Spinal cord stimulation versus conventional medical management for neuropathic pain: A multicentre randomised controlled trial in patients with failed back surgery syndrome.
URL
https://doi.org/10.1111/j.1525-1403.2010.00316.x
Description
Prospective, Two-part Study of the Interaction Between Spinal Cord Stimulation and Peripheral Nerve Field Stimulation in Patients with Low Back Pain: Development of a New Spinal-Peripheral Neurostimulation Method

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Effectiveness of Ecoguided Percutaneous Neuromodulation of the Multipurpose Musculature of L-3 in Non-specific Chronic Lumbar Pain.

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