Chronic Pain. Clinical Trial
Official title:
Primary Motor Cortex Plasticity and the Bottom up Effect of Deep Intramuscular Needling Stimulation Therapy (DIMST)in Osteoarthritis Chronic Pain
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | July 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Hospital de Clínicas de Porto Alegre. | Porto Alegre | Rio Grande do Sul |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital de Clinicas de Porto Alegre | Associação Fundo de Incentivo à Pesquisa |
Brazil,
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. — View 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. — View 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):305-27. — View Citation
Lefaucheur JP, Drouot X, Ménard-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. — View Citation
Lo YL, Cui SL. Acupuncture and the modulation of cortical excitability. Neuroreport. 2003 Jul 1;14(9):1229-31. — View Citation
Schwenkreis P, Scherens A, Rönnau AK, Höffken 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | No |
| Primary | 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 de?ned 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 de?ned 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. | No |
| Primary | 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. | No |
| Secondary | 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. |
Evaluated in one day. The cortical excitability before and within an hour after intervention. | No |
| Secondary | 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. |
Evaluated within twenty four hours before and within one hour after the intervention. | No |
| Secondary | 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. |
Before and within one hour after intervention. | No |
| Secondary | 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. |
Evaluated before and within one hour after intervention. | No |