Hypoalgesic Effect of Electrical Current and Cervical Manipulation

NCT03531541 | Completed

• 1 other identifier: U1111-1212-5389
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the hypoalgesic effect of the TENS application associated with joint manipulation of the cervical region in healthy individuals. One group had both active treatments, the other group received both placebo treatments, the third and fourth group received only one of the two treatments actively and the other placebo

Conditions

Pain

Keywords

TENS; cervical manipulation; pressure pain

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold of the posterior region of the forearm

  The examiner will use a Somedic Type II digital pressure algometer (Somedic Inc, Hörby, Sweden) on the posterior region of the forearm 10cm below the lateral epicondyle of the elbow towards the third finger, with the forearm maintained in pronation. Next, the pressure will be applied perpendicularly to the skin at a rate of 40kPa/s using a flat, 1cm2 circular probe covered with 1mm of rubber to avoid any skin pain from sharp metal edges. The average of the PPT scores (in kPa) will be recorded by the assessor.

  1 minute after the end of the intervention.

Secondary Outcomes (3)

• Pressure Pain Threshold of the posterior region of the forearm

  20 minutes after the end of the intervention

• Pressure Pain Threshold of the tibialis anterior muscle

  1 minute after the end of the intervention.

• Pressure Pain Threshold of the tibialis anterior muscle

  20 minutes after the end of the intervention

Study Arms (4)

active TENS and CJM

ACTIVE COMPARATOR

The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. After application of TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust).

Device: Application of TENS; Device: CJM

placebos TENS and CJM

PLACEBO COMPARATOR

The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies\[42-44\]. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect

Device: Placebo TENS; Device: Placebo CJM

placebo TENS and active CJM

ACTIVE COMPARATOR

The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.

Device: CJM; Device: Placebo TENS

active TENS and placebo CJM

ACTIVE COMPARATOR

The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. After application of placebo TENS The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation.

Device: Application of TENS; Device: Placebo CJM

Interventions

Application of TENS DEVICE

The subject's skin will be cleaned with mild soap and water. Two square self-adhesive electrodes (5x5cm) will be placed 1 cm below the olecranon of the ulna and 10 cm above the radiocarpal joint of the dominant hand, maintaining the PPT measurement region between two electrodes. Two identical TENS units will be used: an active and a placebo (Neurodyn Portable TENS, IBRAMED). The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. Participants will be asked about the intensity of TENS every 5 minutes, and if the intensity has faded, the intensity will be increased again to a strong but comfortable level.

Also known as: Transcutaneous Electrical Nerve Stimulation (TENS)

active TENS and CJM; active TENS and placebo CJM

CJM DEVICE

The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust). If the patient does not experience joint cavitation during the maneuver, two more attempts will be made. If no sound occurs on the third attempt, the joints will be considered manipulated.

Also known as: Cervical Joint Manipulation

active TENS and CJM; placebo TENS and active CJM

Placebo TENS DEVICE

The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Participants will be informed that TENS can cause a slight tingling sensation or any sensation during the procedure. They will be asked every 5 minutes if they are comfortable, without increasing intensity as in the active TENS group

Also known as: Placebo Transcutaneous Electrical Nerve Stimulation (TENS)

placebo TENS and active CJM; placebos TENS and CJM

Placebo CJM DEVICE

Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect. The maneuvers will be carried out by a physiotherapist with more than 5 years of experience in manual therapy. The active or placebo manipulation will be performed on the right or left side according to randomization.

Also known as: Placebo Cervical Joint Manipulation

active TENS and placebo CJM; placebos TENS and CJM

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy subjects
• no pain complaints from the last 90 days

You may not qualify if:

• previous spinal surgeries
• spinal canal stenosis
• vertebral fracture
• spondylolisthesis
• cancer
• acute infections
• hemorrhagic disorders
• active tuberculosis
• deep vein thrombosis
• osteoporosis
• diseases rheumatic
• diseases metabolic
• cardiorespiratory diseases
• headache in the last seven days
• smoking

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead

Study Sites (2)

Centro Universitário Católico Salesiano Auxilium de Lins

Lins, São Paulo, 16400-505, Brazil

Location

Ufscar - Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

Related Publications (48)

• Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6.

  PMID: 10215661 BACKGROUND

• Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available.

  PMID: 5320816 BACKGROUND

• Mayer DJ, Price DD, Rafii A. Antagonism of acupuncture analgesia in man by the narcotic antagonist naloxone. Brain Res. 1977 Feb;121(2):368-72. doi: 10.1016/0006-8993(77)90161-5. No abstract available.

  PMID: 832169 BACKGROUND

• Ha H, Tan EC, Fukunaga H, Aochi O. Naloxone reversal of acupuncture analgesia in the monkey. Exp Neurol. 1981 Jul;73(1):298-303. doi: 10.1016/0014-4886(81)90063-7. No abstract available.

  PMID: 7250283 BACKGROUND

• Citak Karakaya I, Karakaya MG, Ergun E, Elmali S, Firat T. Effects of different frequencies of conventional transcutaneous electrical nerve stimulation on pressure pain threshold and tolerance. J Back Musculoskelet Rehabil. 2014;27(2):197-201. doi: 10.3233/BMR-130436.

  PMID: 24254493 BACKGROUND

• Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.

  PMID: 23900134 BACKGROUND

• Sabino GS, Santos CM, Francischi JN, de Resende MA. Release of endogenous opioids following transcutaneous electric nerve stimulation in an experimental model of acute inflammatory pain. J Pain. 2008 Feb;9(2):157-63. doi: 10.1016/j.jpain.2007.09.003. Epub 2007 Nov 7.

  PMID: 17988952 BACKGROUND

• Chandran P, Sluka KA. Development of opioid tolerance with repeated transcutaneous electrical nerve stimulation administration. Pain. 2003 Mar;102(1-2):195-201. doi: 10.1016/s0304-3959(02)00381-0.

  PMID: 12620611 BACKGROUND

• Han JS, Chen XH, Sun SL, Xu XJ, Yuan Y, Yan SC, Hao JX, Terenius L. Effect of low- and high-frequency TENS on Met-enkephalin-Arg-Phe and dynorphin A immunoreactivity in human lumbar CSF. Pain. 1991 Dec;47(3):295-298. doi: 10.1016/0304-3959(91)90218-M.

  PMID: 1686080 BACKGROUND

• Flynn TW, Childs JD, Fritz JM. The audible pop from high-velocity thrust manipulation and outcome in individuals with low back pain. J Manipulative Physiol Ther. 2006 Jan;29(1):40-5. doi: 10.1016/j.jmpt.2005.11.005.

  PMID: 16396728 BACKGROUND

• Dunning J, Rushton A. The effects of cervical high-velocity low-amplitude thrust manipulation on resting electromyographic activity of the biceps brachii muscle. Man Ther. 2009 Oct;14(5):508-13. doi: 10.1016/j.math.2008.09.003. Epub 2008 Nov 21.

  PMID: 19027344 BACKGROUND

• DeVocht JW, Pickar JG, Wilder DG. Spinal manipulation alters electromyographic activity of paraspinal muscles: a descriptive study. J Manipulative Physiol Ther. 2005 Sep;28(7):465-71. doi: 10.1016/j.jmpt.2005.07.002.

  PMID: 16182019 BACKGROUND

• Evans DW. Mechanisms and effects of spinal high-velocity, low-amplitude thrust manipulation: previous theories. J Manipulative Physiol Ther. 2002 May;25(4):251-62. doi: 10.1067/mmt.2002.123166.

  PMID: 12021744 BACKGROUND

• Achalandabaso A, Plaza-Manzano G, Lomas-Vega R, Martinez-Amat A, Camacho MV, Gasso M, Hita-Contreras F, Molina F. Tissue damage markers after a spinal manipulation in healthy subjects: a preliminary report of a randomized controlled trial. Dis Markers. 2014;2014:815379. doi: 10.1155/2014/815379. Epub 2014 Dec 25.

  PMID: 25609853 BACKGROUND

• Wright A. Hypoalgesia post-manipulative therapy: a review of a potential neurophysiological mechanism. Man Ther. 1995 Nov;1(1):11-6. doi: 10.1054/math.1995.0244.

  PMID: 11327789 BACKGROUND

• Pickar JG, Wheeler JD. Response of muscle proprioceptors to spinal manipulative-like loads in the anesthetized cat. J Manipulative Physiol Ther. 2001 Jan;24(1):2-11. doi: 10.1067/mmt.2001.112017.

  PMID: 11174689 BACKGROUND

• Maigne JY, Vautravers P. Mechanism of action of spinal manipulative therapy. Joint Bone Spine. 2003 Sep;70(5):336-41. doi: 10.1016/s1297-319x(03)00074-5.

  PMID: 14563460 BACKGROUND

• Randoll C, Gagnon-Normandin V, Tessier J, Bois S, Rustamov N, O'Shaughnessy J, Descarreaux M, Piche M. The mechanism of back pain relief by spinal manipulation relies on decreased temporal summation of pain. Neuroscience. 2017 May 4;349:220-228. doi: 10.1016/j.neuroscience.2017.03.006. Epub 2017 Mar 11.

  PMID: 28288900 BACKGROUND

• Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

  PMID: 19027342 BACKGROUND

• Coronado RA, Gay CW, Bialosky JE, Carnaby GD, Bishop MD, George SZ. Changes in pain sensitivity following spinal manipulation: a systematic review and meta-analysis. J Electromyogr Kinesiol. 2012 Oct;22(5):752-67. doi: 10.1016/j.jelekin.2011.12.013. Epub 2012 Jan 30.

  PMID: 22296867 BACKGROUND

• Savva C, Giakas G, Efstathiou M. The role of the descending inhibitory pain mechanism in musculoskeletal pain following high-velocity, low amplitude thrust manipulation: a review of the literature. J Back Musculoskelet Rehabil. 2014;27(4):377-82. doi: 10.3233/BMR-140472.

  PMID: 24867897 BACKGROUND

• Gay CW, Robinson ME, George SZ, Perlstein WM, Bishop MD. Immediate changes after manual therapy in resting-state functional connectivity as measured by functional magnetic resonance imaging in participants with induced low back pain. J Manipulative Physiol Ther. 2014 Nov-Dec;37(9):614-27. doi: 10.1016/j.jmpt.2014.09.001. Epub 2014 Oct 3.

  PMID: 25284739 BACKGROUND

• Jordon MK, Beattie PF, D'Urso S, Scriven S. Spinal manipulation does not affect pressure pain thresholds in the absence of neuromodulators: a randomized controlled trial. J Man Manip Ther. 2017 Sep;25(4):172-181. doi: 10.1080/10669817.2016.1230352. Epub 2016 Sep 12.

  PMID: 28912629 BACKGROUND

• Boal RW, Gillette RG. Central neuronal plasticity, low back pain and spinal manipulative therapy. J Manipulative Physiol Ther. 2004 Jun;27(5):314-26. doi: 10.1016/j.jmpt.2004.04.005.

  PMID: 15195039 BACKGROUND

• Molina-Ortega F, Lomas-Vega R, Hita-Contreras F, Plaza Manzano G, Achalandabaso A, Ramos-Morcillo AJ, Martinez-Amat A. Immediate effects of spinal manipulation on nitric oxide, substance P and pain perception. Man Ther. 2014 Oct;19(5):411-7. doi: 10.1016/j.math.2014.02.007. Epub 2014 Mar 5.

  PMID: 24674816 BACKGROUND

• Nakatsuka T, Chen M, Takeda D, King C, Ling J, Xing H, Ataka T, Vierck C, Yezierski R, Gu JG. Substance P-driven feed-forward inhibitory activity in the mammalian spinal cord. Mol Pain. 2005 Jun 29;1:20. doi: 10.1186/1744-8069-1-20.

  PMID: 15987503 BACKGROUND

• Wu LJ, Xu H, Ko SW, Yoshimura M, Zhuo M. Feed-forward inhibition: a novel cellular mechanism for the analgesic effect of substance P. Mol Pain. 2005 Nov 18;1:34. doi: 10.1186/1744-8069-1-34.

  PMID: 16297242 BACKGROUND

• Pantaleao MA, Laurino MF, Gallego NL, Cabral CM, Rakel B, Vance C, Sluka KA, Walsh DM, Liebano RE. Adjusting pulse amplitude during transcutaneous electrical nerve stimulation (TENS) application produces greater hypoalgesia. J Pain. 2011 May;12(5):581-90. doi: 10.1016/j.jpain.2010.11.001. Epub 2011 Feb 1.

  PMID: 21277840 BACKGROUND

• Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

  PMID: 16139163 BACKGROUND

• Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.

  PMID: 21144659 BACKGROUND

• Leffler AS, Hansson P, Kosek E. Somatosensory perception in patients suffering from long-term trapezius myalgia at the site overlying the most painful part of the muscle and in an area of pain referral. Eur J Pain. 2003;7(3):267-76. doi: 10.1016/S1090-3801(02)00138-6.

  PMID: 12725850 BACKGROUND

• Liebano RE, Vance CG, Rakel BA, Lee JE, Cooper NA, Marchand S, Walsh DM, Sluka KA. Transcutaneous electrical nerve stimulation and conditioned pain modulation influence the perception of pain in humans. Eur J Pain. 2013 Nov;17(10):1539-46. doi: 10.1002/j.1532-2149.2013.00328.x. Epub 2013 May 6.

  PMID: 23650092 BACKGROUND

• Walton DM, Macdermid JC, Nielson W, Teasell RW, Chiasson M, Brown L. Reliability, standard error, and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain. J Orthop Sports Phys Ther. 2011 Sep;41(9):644-50. doi: 10.2519/jospt.2011.3666. Epub 2011 Sep 1.

  PMID: 21885906 BACKGROUND

• Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.

  PMID: 25844555 BACKGROUND

• Staud R. Treatment of fibromyalgia and its symptoms. Expert Opin Pharmacother. 2007 Aug;8(11):1629-42. doi: 10.1517/14656566.8.11.1629.

  PMID: 17685881 BACKGROUND

• Moran F, Leonard T, Hawthorne S, Hughes CM, McCrum-Gardner E, Johnson MI, Rakel BA, Sluka KA, Walsh DM. Hypoalgesia in response to transcutaneous electrical nerve stimulation (TENS) depends on stimulation intensity. J Pain. 2011 Aug;12(8):929-35. doi: 10.1016/j.jpain.2011.02.352. Epub 2011 Apr 9.

  PMID: 21481649 BACKGROUND

• Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CG, Walsh DM, Sluka KA. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010 Mar;11(3):230-8. doi: 10.1016/j.jpain.2009.07.007. Epub 2009 Nov 27.

  PMID: 19945354 BACKGROUND

• Fernandez-Carnero J, Fernandez-de-Las-Penas C, de la Llave-Rincon AI, Ge HY, Arendt-Nielsen L. Widespread mechanical pain hypersensitivity as sign of central sensitization in unilateral epicondylalgia: a blinded, controlled study. Clin J Pain. 2009 Sep;25(7):555-61. doi: 10.1097/AJP.0b013e3181a68a040.

  PMID: 19692795 BACKGROUND

• Saiz-Llamosas JR, Fernandez-Perez AM, Fajardo-Rodriguez MF, Pilat A, Valenza-Demet G, Fernandez-de-Las-Penas C. Changes in neck mobility and pressure pain threshold levels following a cervical myofascial induction technique in pain-free healthy subjects. J Manipulative Physiol Ther. 2009 Jun;32(5):352-7. doi: 10.1016/j.jmpt.2009.04.009.

  PMID: 19539117 BACKGROUND

• Fernandez-de-las-Penas C, Perez-de-Heredia M, Brea-Rivero M, Miangolarra-Page JC. Immediate effects on pressure pain threshold following a single cervical spine manipulation in healthy subjects. J Orthop Sports Phys Ther. 2007 Jun;37(6):325-9. doi: 10.2519/jospt.2007.2542.

  PMID: 17612359 BACKGROUND

• Vernon HT, Triano JJ, Ross JK, Tran SK, Soave DM, Dinulos MD. Validation of a novel sham cervical manipulation procedure. Spine J. 2012 Nov;12(11):1021-8. doi: 10.1016/j.spinee.2012.10.009. Epub 2012 Nov 15.

  PMID: 23158966 BACKGROUND

• Gomes Ade O, Silvestre AC, Silva CF, Gomes MR, Bonfleur ML, Bertolini GR. Influence of different frequencies of transcutaneous electrical nerve stimulation on the threshold and pain intensity in young subjects. Einstein (Sao Paulo). 2014 Sep;12(3):318-22. doi: 10.1590/s1679-45082014ao3092.

  PMID: 25295453 BACKGROUND

• Wassinger CA, Rich D, Cameron N, Clark S, Davenport S, Lingelbach M, Smith A, Baxter GD, Davidson J. Cervical & thoracic manipulations: Acute effects upon pain pressure threshold and self-reported pain in experimentally induced shoulder pain. Man Ther. 2016 Feb;21:227-32. doi: 10.1016/j.math.2015.08.009. Epub 2015 Aug 28.

  PMID: 26391291 BACKGROUND

• Chesterton LS, Foster NE, Wright CC, Baxter GD, Barlas P. Effects of TENS frequency, intensity and stimulation site parameter manipulation on pressure pain thresholds in healthy human subjects. Pain. 2003 Nov;106(1-2):73-80. doi: 10.1016/s0304-3959(03)00292-6.

  PMID: 14581113 BACKGROUND

• Tanaka K, Ikeuchi M, Izumi M, Aso K, Sugimura N, Enoki H, Nagano Y, Ishida K, Tani T. Effects of two different intensities of transcutaneous electrical nerve stimulation on pain thresholds of contralateral muscles in healthy subjects. J Phys Ther Sci. 2015 Sep;27(9):2771-4. doi: 10.1589/jpts.27.2771. Epub 2015 Sep 30.

  PMID: 26504290 BACKGROUND

• Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.

  PMID: 19028251 BACKGROUND

• Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070.

  PMID: 19158541 RESULT

• Telles JD, Gabanela Schiavon MA, Rampazo da Silva EP, Liebano RE. Transcutaneous electrical nerve stimulation and cervical joint manipulation on pressure pain threshold. Pain Manag. 2018 Jul 1;8(4):263-269. doi: 10.2217/pmt-2017-0069. Epub 2018 Jun 1.

  PMID: 29856269 DERIVED

Related Links

• The effect of manipulation and mobilisation on pressure pain thresholds in the thoracic spine

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Richard E Liebano, Dr.

  Universidade Federal de São Carlos - UFScar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinding will be assessed by examiner 2 (responsible for administering TENS) asking the participants which TENS intervention they think they received, with 3 options for the answer: "active," "placebo" or "don't know". The same questions will be asked by examiner 2 for CJM. Next, examiner 3 (responsible for administering CJM) will receive the blinding outcome and have 3 options for the answer: "active," "placebo" or "don't know". Examiner 1 will receive the blinding outcome will be asked: "Which group does the patient belong to: active TENS and CJM, active TENS and placebo CJM, placebo TENS and active CJM or placebo TENS and CJM" Their responses to these questions will be recorded and used to measure the adequacy of participants and examiners
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The participants will be randomly allocated into 4 groups: (G1) active TENS and CJM, (G2) placebo TENS and CJM, (G3) placebo TENS and active CJM, (G4) active TENS and placebo CJM.

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 21, 2018
• Study Start: May 10, 2018
• Primary Completion: November 20, 2018
• Study Completion: January 27, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)