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Motor Cortex Plasticity and the Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST) in Osteoarthritis Pain

Primary Purpose

Knee Osteoarthritis, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DIMST
Placebo-sham
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Electro acupuncture, Deep intramuscular stimulation, Transcranial Magnetic Stimulation, Pain pressure threshold, Conditioned pain modulation, Clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with over 18 years old, with chronic pain because of primary osteoarthritis of the knee.
  • Pain stable for at least three months. Score greater than or equal to 3 cm (0 cm = "no pain" and "worst possible pain" = 10cm) on VAS for pain perception at baseline.
  • No contraindications to electro acupuncture or transcranial magnetic stimulation.
  • Naive in acupuncture treatment.

Exclusion Criteria:

  • Clinically significant or unstable disorder, medical or psychiatric.
  • Presence of neurological or rheumatic comorbidity.
  • Pregnancy.
  • Having performed surgery in the knee to be treated in the last 6 months, or be planning surgery for the next semester.
  • Having performed with corticosteroid infiltration in the last six weeks or are using this.
  • Having performed with hyaluronic acid infiltration.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

DIMST

Placebo-sham

Arm Description

The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.

The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.

Outcomes

Primary Outcome Measures

Pain Pressure Threshold (PPT) After Intervention..
PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes. # Below, the data after intervention.
Motor Evoked Potential (MEP) After Intervention.
Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag-AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was defined as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials. MEP was defined as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP). # Below the data after intervention.
Conditioned Pain Modulation (CPM) After Intervention.
PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject. # Below the data after intervention.

Secondary Outcome Measures

Intracortical Inhibition (ICI) After Intervention.
ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP. # Below the data after intervention.
Pain Intensity After Intervention.
The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm). # Below the data after intervention.
Intracortical Facilitation (ICF) After Intervention.
ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP. # Below the data after intervention.
Cortical Silent Period (CSP) After Intervention.
To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject. # Below the data after intervention.

Full Information

First Posted
May 8, 2013
Last Updated
August 17, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01855958
Brief Title
Motor Cortex Plasticity and the Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST) in Osteoarthritis Pain
Official Title
Primary Motor Cortex Plasticity and the Bottom up Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST)in Osteoarthritis Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the cortical excitability in pain of knee osteoarthritis (OA), as well as the effect of one session of a kind of electroacupuncture (deep needling intramuscular stimulation therapy - DIMST) in this pain and the cortical excitability after the intervention. The hypothesis is that cortical excitability is altered in this condition, confirming the findings already described in other chronic pain conditions. The investigators also believe that a session DIMST can reduce pain and alter cortical excitability, restoring its previous activity will occur from chronic pain.
Detailed Description
Recent developments in the treatment of chronic pain have shown that the primary motor cortex (M1) is an effective target for neural brain stimulation techniques, such as transcranial magnetic stimulation (TMS). Due to these promising initial results, the plasticity of M1 has also been investigated as a potential marker for chronic pain. TMS studies using single or paired pulse shown changes in M1 plasticity in neuropathic pain and fibromyalgia pain compared to healthy subjects. Thus, there is a decrease in the inhibitory activity of chronic pain that can take a state as shown uninhibited by measuring TMS indexed intracortical inhibition (ICI) and cortical silent period (CSP). Based on these experimental data and clinical studies have been focused on the effects of neuromodulation techniques in M1 excitability. The techniques used to stimulate the peripheral nervous system was investigated using different approaches. The DIMST is a therapy applied to treat peripheral chronic syndromes that may have central components such as myofascial pain. During DIMST, the needles are applied to the spinal segment associated with nerve roots dermatome corresponding to the pathology. This treatment can also be effective in the treatment of diseases that have major peripheral components such as OA. OA is a major cause of suffering and disability in the elderly, having an inflammatory component, such as a factor that contributes to the symptoms and progression of the disease. There is evidence that OA could lead to sensitization central and segmental, but these effects on M1 plasticity and other central components are not completely known. Therefore, researchers proposed to evaluate the plasticity of M1 in this chronic pain condition and also the effect of bottom-up DIMST in pain and cortical excitability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Chronic Pain
Keywords
Osteoarthritis, Electro acupuncture, Deep intramuscular stimulation, Transcranial Magnetic Stimulation, Pain pressure threshold, Conditioned pain modulation, Clinical trial

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DIMST
Arm Type
Experimental
Arm Description
The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
Arm Title
Placebo-sham
Arm Type
Sham Comparator
Arm Description
The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
Intervention Type
Procedure
Intervention Name(s)
DIMST
Other Intervention Name(s)
Paraspinal electro acupuncture.
Intervention Description
The investigators used electro acupuncture of 2 Hz during 30 minutes.
Intervention Type
Procedure
Intervention Name(s)
Placebo-sham
Other Intervention Name(s)
Electrostimulation with rubber electrodes.
Intervention Description
Electro acupuncture with rubber electrodes, without current passing.
Primary Outcome Measure Information:
Title
Pain Pressure Threshold (PPT) After Intervention..
Description
PPT (alone): The patient was instructed to verbally report the perception of pain onset. The investigator assessed PPT using an electronic algometer (J Tech Medical Industries, USA). The device had a 1-cm2 hard-rubber probe, which was applied over structures at L1- L5 dermatome at the knee and at the contralateral forearm. The average values of PPT in kgf/cm2 for three successive readings taken at intervals of 3-5 min were used as the outcomes. # Below, the data after intervention.
Time Frame
Before and within one hour after intervention.
Title
Motor Evoked Potential (MEP) After Intervention.
Description
Cortical excitability was assessed using a MagPro X100 (MagVenture Company, Lucernemarken, Denmark) and a figure-of-8 coil centered over the left motor cortex (M1). Subjects were seated in a comfortable reclining chair with their arms and hands lying relaxed on the armrests. The investigators measured the resting motor threshold (rMT) of the right first dorsal interosseous (FDI) muscle. The MEPs were recorded by surface electromyography (EMG) using Ag-AgCl cup electrodes in a belly tendon montage. Resting motor threshold (rMT) was defined as the stimulus intensity at which peak-to-peak MEP amplitude of 50 µV (microvolts) was obtained in at least 5 of 10 consecutive trials. MEP was defined as approximately 130% of the rMT or the stimulus intensity at which peak-to-peak MEP amplitude of at least 1 mV was obtained in 10 consecutive trials. The result of the MEP was the average of 10 curves (unconditioned MEP). # Below the data after intervention.
Time Frame
Before and within one hour after intervention.
Title
Conditioned Pain Modulation (CPM) After Intervention.
Description
PPT during cold water immersion (PPT+CPM): By measuring PPT during cold water immersion, we evaluated the degree to which pain perception is modulated by conditioned pain modulation (CPM) following the presentation of an initial heterotopic noxious stimulus. Subjects immersed their left hands into cold water (zero to 1°C) for 1 minute. During the last 30 seconds of cold-water immersion, the PPT procedure was administered at the right forearm. The temperature was held constant across during the experiment for each subject. # Below the data after intervention.
Time Frame
Before and within one hour after intervention.
Secondary Outcome Measure Information:
Title
Intracortical Inhibition (ICI) After Intervention.
Description
ICI was evaluated using inter-stimuli intervals (ISIs) of 2 ms with paired-pulse stimulation. The subthreshold stimulus was set at 80% of rMT (conditioning stimulus) , and the suprathreshold test stimulus was set at 130% of rMT. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEPs). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICI was done by the ratio of the mean ICI by the mean MEP. # Below the data after intervention.
Time Frame
Evaluated in one day. The cortical excitability before and within an hour after intervention.
Title
Pain Intensity After Intervention.
Description
The intensity of pain was measured by a 10-cm VAS. VAS scores ranged from no pain (zero) to the worst possible pain possible (10 cm). The pain score on VAS during the last 24 hours was used to classify the subjects into two groups: (1) absence of pain or mild pain (scores equal to or lower than 4 cm) and (2) moderate, intense, or worst possible pain (scores higher than 4 cm). # Below the data after intervention.
Time Frame
Evaluated within twenty four hours before and within one hour after the intervention.
Title
Intracortical Facilitation (ICF) After Intervention.
Description
ICF was evaluated using an inter-stimuli intervals (ISIs) of 12 ms with paired-pulse and similar parameters for the conditioning and test stimuli. After a randomized protocol, thirty stimuli were assessed using a 2ms interval (ICI), a 12ms interval (ICF) and test-only trials (MEP). The resulting MEP amplitude was converted into the mean amplitude, and paired-pulse parameters were expressed as the amount of inhibition or facilitation. The calculation result of ICF was done by the ratio of the mean ICF by the mean MEP. # Below the data after intervention.
Time Frame
Before and within one hour after intervention.
Title
Cortical Silent Period (CSP) After Intervention.
Description
To determine the cortical silent period (CSP), subjects were instructed to squeeze the dynamometer using their fingers at 20% of maximal force when a single pulse stimulus (130% rMT) was applied. The result was the average of five consecutive measurements. The CSP was determined by the interval between the stimulus and the motor response elicited in the subject. # Below the data after intervention.
Time Frame
Evaluated before and within one hour after intervention.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with over 18 years old, with chronic pain because of primary osteoarthritis of the knee. Pain stable for at least three months. Score greater than or equal to 3 cm (0 cm = "no pain" and "worst possible pain" = 10cm) on VAS for pain perception at baseline. No contraindications to electro acupuncture or transcranial magnetic stimulation. Naive in acupuncture treatment. Exclusion Criteria: Clinically significant or unstable disorder, medical or psychiatric. Presence of neurological or rheumatic comorbidity. Pregnancy. Having performed surgery in the knee to be treated in the last 6 months, or be planning surgery for the next semester. Having performed with corticosteroid infiltration in the last six weeks or are using this. Having performed with hyaluronic acid infiltration.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolnei Caumo, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria L Tarragó, MD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre.
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17101886
Citation
Lefaucheur JP, Drouot X, Menard-Lefaucheur I, Keravel Y, Nguyen JP. Motor cortex rTMS restores defective intracortical inhibition in chronic neuropathic pain. Neurology. 2006 Nov 14;67(9):1568-74. doi: 10.1212/01.wnl.0000242731.10074.3c.
Results Reference
background
PubMed Identifier
22632870
Citation
Zunhammer M, Eichhammer P, Franz J, Hajak G, Busch V. Effects of acupuncture needle penetration on motor system excitability. Neurophysiol Clin. 2012 Jun;42(4):225-30. doi: 10.1016/j.neucli.2012.02.134. Epub 2012 Mar 6.
Results Reference
background
PubMed Identifier
12824765
Citation
Lo YL, Cui SL. Acupuncture and the modulation of cortical excitability. Neuroreport. 2003 Jul 1;14(9):1229-31. doi: 10.1097/00001756-200307010-00008.
Results Reference
background
PubMed Identifier
18821657
Citation
Imamura M, Imamura ST, Kaziyama HH, Targino RA, Hsing WT, de Souza LP, Cutait MM, Fregni F, Camanho GL. Impact of nervous system hyperalgesia on pain, disability, and quality of life in patients with knee osteoarthritis: a controlled analysis. Arthritis Rheum. 2008 Oct 15;59(10):1424-31. doi: 10.1002/art.24120.
Results Reference
background
PubMed Identifier
20540759
Citation
Schwenkreis P, Scherens A, Ronnau AK, Hoffken O, Tegenthoff M, Maier C. Cortical disinhibition occurs in chronic neuropathic, but not in chronic nociceptive pain. BMC Neurosci. 2010 Jun 11;11:73. doi: 10.1186/1471-2202-11-73.
Results Reference
background
PubMed Identifier
22752510
Citation
Laste G, Caumo W, Adachi LN, Rozisky JR, de Macedo IC, Filho PR, Partata WA, Fregni F, Torres IL. After-effects of consecutive sessions of transcranial direct current stimulation (tDCS) in a rat model of chronic inflammation. Exp Brain Res. 2012 Aug;221(1):75-83. doi: 10.1007/s00221-012-3149-x. Epub 2012 Jul 3.
Results Reference
background
PubMed Identifier
460936
Citation
Le Bars D, Dickenson AH, Besson JM. Diffuse noxious inhibitory controls (DNIC). II. Lack of effect on non-convergent neurones, supraspinal involvement and theoretical implications. Pain. 1979 Jun;6(3):305-327. doi: 10.1016/0304-3959(79)90050-2.
Results Reference
background

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Motor Cortex Plasticity and the Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST) in Osteoarthritis Pain

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