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

NCT01855958 | Completed Results DMC

• 1 other identifier: 11-0013
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Chronic Pain

Keywords

Osteoarthritis; Electro acupuncture; Deep intramuscular stimulation; Transcranial Magnetic Stimulation; Pain pressure threshold; Conditioned pain modulation; Clinical trial

Outcome Measures

Primary Outcomes (3)

• 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.

  Before and within one hour 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.

  Before and within one hour 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.

  Before and within one hour after intervention.

Secondary Outcomes (4)

• Intracortical Inhibition (ICI) After Intervention.

  Evaluated in one day. The cortical excitability before and within an hour after intervention.

• Pain Intensity After Intervention.

  Evaluated within twenty four hours before and within one hour after the intervention.

• Intracortical Facilitation (ICF) After Intervention.

  Before and within one hour after intervention.

• Cortical Silent Period (CSP) After Intervention.

  Evaluated before and within one hour after intervention.

Study Arms (2)

DIMST

EXPERIMENTAL

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.

Procedure: DIMST

Placebo-sham

SHAM COMPARATOR

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.

Procedure: Placebo-sham

Interventions

DIMST PROCEDURE

The investigators used electro acupuncture of 2 Hz during 30 minutes.

Also known as: Paraspinal electro acupuncture.

DIMST

Placebo-sham PROCEDURE

Electro acupuncture with rubber electrodes, without current passing.

Also known as: Electrostimulation with rubber electrodes.

Placebo-sham

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Associação Fundo de Incentivo à Pesquisa: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre.

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (7)

• 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.

  PMID: 17101886 BACKGROUND

• 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.

  PMID: 22632870 BACKGROUND

• 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.

  PMID: 12824765 BACKGROUND

• 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.

  PMID: 18821657 BACKGROUND

• 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.

  PMID: 20540759 BACKGROUND

• 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.

  PMID: 22752510 BACKGROUND

• 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.

  PMID: 460936 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Wolnei Caumo, MD,PhD.
• Organization: Hospital de Clínicas de Porto Alegre

caumo@cpovo.net

+555133598430

Study Officials

• Wolnei Caumo, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

• Maria L Tarragó, MD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 17, 2013
• Study Start: February 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 15, 2017
• Results First Posted: September 22, 2015

Record last verified: 2015-08

Locations

BR (1)