Effect of Cranial Stimulation and Acupuncture on Pain, Functional Capability and Cerebral Function in Osteoarthritis

NCT01747070 | Completed DMC

• 2 other identifiers: 110013U1111-1130-1855
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the efficacy of transcranial direct current stimulation (tDCS) and electro acupuncture (EAC) compared to sham treatment in reducing pain, improving functional capacity and functioning of the neuro-immune-endocrine system in patients with chronic pain due to knee osteoarthritis.

Conditions

Osteoarthritis, Knee; Chronic Pain

Keywords

Electro Acupuncture; Knee Osteoarthritis; Chronic pain; Cortical Excitability

Outcome Measures

Primary Outcomes (2)

• Change in the intensity of daily pain.

  Measurement of outcomes by clinical parameters: Pain - The pain daily, in the course of treatment will be measured by the Visual Analog Scale, (VAS) 10 cm where zero corresponds to no pain and 10 cm maximum pain.

  The treatment will be 5 daily sessions.The pain level will be assessed before treatment, after each session and at the end of treatment.Totaling six days.

• Change in the pressure pain threshold.

  Measurement of outcomes by parameters of pain threshold: Threshold Tolerance Test Algometry Pressure: the tolerance threshold pressure is measured by pressure algometer digital, with an area of 1 cm2 in area with muscle trigger point that triggers more pain. The maximum pressure to be applied will be 1400 kPa (Kilopascal) to avoid tissue damage. The patient will be instructed to indicate when the stimulus becomes unbearable and the value of tolerance threshold will be constituted by the average of three measurements.

  The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.

Secondary Outcomes (4)

• State of physical and mental health.

  The state of physical and mental health will be assessed before and after treatment. Totaly five days.

• Level of depressive symptoms .

  Depressive symptoms will be assessed before and after treatment. Totaly five days.

• Daily sleep quality.

  Sleep quality will be evaluated daily, totaling five days of evaluation.

• Change in the level of functionality.

  The functionality level will be evaluated before and after 5 daily sessions of treatment.Totaling six days.

Other Outcomes (1)

• Cortical excitability:Motor threshold (MT), Motor evoked potential (MEP),silent period (SP), intracortical facilitation (ICF)and intracortical inhibition (ICI).

  The cortical excitability is evaluated before and after treatment with a transcranial magnetic stimulation (TMS) equipment.

Study Arms (4)

tDCS and EAC sham

ACTIVE COMPARATOR

Subjects will receive 05 sessions of tDCS. The tDCS consist of application of current of 2 mA, the anode being placed in the motor cortex (M1) and the cathode in the supraorbital region, for 30 minutes,using electrodes with saline solution. The sham DIMST consist of the use of rubber electrodes placed in the same places that active treatment. Will use the same electrical apparatus, but without pass of current to the electrodes. The unit will be in front of the patient on with their lights blinking.

Other: tDCS and EAC sham

tDCS sham and EAC sham

PLACEBO COMPARATOR

The subjects will receive 05 sessions of tDCS sham and EAC sham. The sham tDCS be performed in the same way as the active, although the Electro device is turned off 30 seconds after the beginning of treatment, the session will have the same duration of 30 minutes. The EAC sham consists of placement of rubber electrodes in the same areas of active stimulation (beside the spinous processes of L1 to S2, muscles vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus). The electrodes are connected to the same device electro, for 30 minutes, but without passage of electrical stimulation to the patient. The device is kept on and in front of the patient, with the lights blinking.

Other: tDCS sham and EAC sham

tDCS sham and EAC

ACTIVE COMPARATOR

Subjects will receive 05 sessions of tDCS sham and EAC.The sham tDCS be performed in the same way as the active, although the Electro device is turned off 30 seconds after the beginning of treatment, the session will have the same duration of 30 minutes. The EAC consist of electrical stimulation with a frequency of 2 Hz for 30 min. The needles are placed beside the spinous processes of L1 to S2, with a depth of 3 cm and in the muscles: vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus.

Other: tDCS sham and EAC

tDCS and EAC

EXPERIMENTAL

Subjects will receive 05 sessions of transcranial direct current stimulation(tDCS) and electroacupuncture(EAC). The tDCS consist of application of current of 2 mA, the anode being placed in the motor cortex (M1) and the cathode in the supraorbital region, for 30 minutes,using electrodes with saline. The electroacupuncture consist of electrical stimulation with a frequency of 2 Hz for 30 min. The needles are placed beside the spinous processes of L1 to S2, with a depth of 3 cm and in the muscles: vastus lateralis, rectus anterioris, vastus medialis, tibialis anterior, peroneus longus and insertion of the pes anserinus.

Other: tDCS and EAC

Interventions

tDCS and EAC sham OTHER

The tDCS apparatus is operated on battery power, will be used rubber electrodes soaked in saline solution. The anode is placed in M1 and the cathode in the supraorbital region.

Also known as: Transcranial direct current stimulation.

tDCS and EAC sham

tDCS sham and EAC sham OTHER

For the EAC sham we will use rubber electrodes. They will be applied in the same areas of active EAC. They are connected to the same electroacupuncture device, but without current passing for the patient. All subjects receive one 30min session.

Also known as: DIMST: deep intramuscular stimulation.

tDCS sham and EAC sham

tDCS sham and EAC OTHER

For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.

Also known as: DIMST

tDCS sham and EAC

tDCS and EAC OTHER

For the acupuncture we will use needles with guide tubes that are 40 mm in length and 0.25 mm in diameter. The needling will be applied using an electro acupuncture device in the dermatomes, myotome, or sclerotome corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). All patients received one 30min session using a frequency of 2 Hz.

Also known as: DIMST

tDCS and EAC

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 Visual Analog Scale (VAS) for pain perception at baseline.
• No contraindications to electroacupuncture, transcranial direct current stimulation or transcranial magnetic stimulation.

You may not qualify if:

• Presence of neurological or rheumatic comorbidity.
• Pregnancy.
• Already having been treated with acupuncture.
• Having performed with corticosteroid infiltration in the last six weeks or are using this.
• Having performed with hyaluronic acid infiltration in the last year.
• Previous surgery on the limb to be treated or have surgical program for the next 6 months.

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 (12)

• Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.

  PMID: 18541887 BACKGROUND

• 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

• Zaghi S, Thiele B, Pimentel D, Pimentel T, Fregni F. Assessment and treatment of pain with non-invasive cortical stimulation. Restor Neurol Neurosci. 2011;29(6):439-51. doi: 10.3233/RNN-2011-0615.

  PMID: 22124038 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

• Srbely JZ, Dickey JP, Lee D, Lowerison M. Dry needle stimulation of myofascial trigger points evokes segmental anti-nociceptive effects. J Rehabil Med. 2010 May;42(5):463-8. doi: 10.2340/16501977-0535.

  PMID: 20544158 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

• Boggio PS, Amancio EJ, Correa CF, Cecilio S, Valasek C, Bajwa Z, Freedman SD, Pascual-Leone A, Edwards DJ, Fregni F. Transcranial DC stimulation coupled with TENS for the treatment of chronic pain: a preliminary study. Clin J Pain. 2009 Oct;25(8):691-5. doi: 10.1097/AJP.0b013e3181af1414.

  PMID: 19920718 BACKGROUND

• da Graca-Tarrago M, Lech M, Angoleri LDM, Santos DS, Deitos A, Brietzke AP, Torres IL, Fregni F, Caumo W. Intramuscular electrical stimulus potentiates motor cortex modulation effects on pain and descending inhibitory systems in knee osteoarthritis: a randomized, factorial, sham-controlled study. J Pain Res. 2019 Jan 3;12:209-221. doi: 10.2147/JPR.S181019. eCollection 2019.

  PMID: 30655690 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Interventions

Transcranial Direct Current Stimulation; D-4-chloro-17 beta-hydroxy-3-oxo-17 alpha-methylandrosta-1,4-diene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wolnei Caumo, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: December 11, 2012
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

BR (1)