Hypoalgesic Effect of Electrical Current and Cervical Manipulation

NCT ID: NCT03531541

Last Updated: 2019-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Transcutaneous Electrical Nerve Stimulation (TENS) and Cervical Joint Manipulation (CJM) are often used for pain treatment.

TENS also promotes analgesia by activating a descending pathway, which originates in the periaqueductal grey (PAG) and in the rostroventromedial medulla (RVM) to inhibit the excitability of nociceptive neurons in the dorsal horn of the spinal cord.

Joint manipulation generates a series of stimuli within the central nervous system through the activation of proprioceptors located in the joint capsule or muscles, stimulates the PAG, causing pain inhibition by activation of non-opioid descending inhibitory pathways

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

active TENS and CJM

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).

Group Type ACTIVE_COMPARATOR

Application of TENS

Intervention Type 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.

CJM

Intervention Type 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.

placebos TENS and CJM

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

Group Type PLACEBO_COMPARATOR

Placebo TENS

Intervention Type 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

Placebo CJM

Intervention Type 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.

placebo TENS and active CJM

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.

Group Type ACTIVE_COMPARATOR

CJM

Intervention Type 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.

Placebo TENS

Intervention Type 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

active TENS and placebo CJM

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.

Group Type ACTIVE_COMPARATOR

Application of TENS

Intervention Type 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.

Placebo CJM

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Application of TENS

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.

Intervention Type DEVICE

CJM

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.

Intervention Type DEVICE

Placebo TENS

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

Intervention Type DEVICE

Placebo CJM

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Transcutaneous Electrical Nerve Stimulation (TENS) Cervical Joint Manipulation Placebo Transcutaneous Electrical Nerve Stimulation (TENS) Placebo Cervical Joint Manipulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
* changes in skin sensitivity
* use of pacemaker
* women in menstrual period
* pregnant women
* use of pain-killers in the last 48 hours
* use of anti-inflammatory drugs in the last 48 hours
* previous electrostimulation
* previous cervical joint manipulation treatments
* hypersensitivity to TENS application
* aversion to cervical joint manipulation
* positive test for vertebral artery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jonathan Daniel Telles

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard E Liebano, Dr.

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Carlos - UFScar

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Universitário Católico Salesiano Auxilium de Lins

Lins, São Paulo, Brazil

Site Status

Ufscar - Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10215661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5320816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 832169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7250283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24254493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23900134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17988952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12620611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1686080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16396728 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19027344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16182019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12021744 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25609853 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11327789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11174689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14563460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28288900 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19027342 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22296867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24867897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25284739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28912629 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15195039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24674816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15987503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16297242 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21277840 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16139163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21144659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12725850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23650092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21885906 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25844555 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17685881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21481649 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19945354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19692795 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19539117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17612359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23158966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25295453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26391291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14581113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26504290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19028251 (View on PubMed)

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.

Reference Type RESULT
PMID: 19158541 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29856269 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://vuir.vu.edu.au/500/1/Manipulation_and_mobilisation_2004.pdf

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1212-5389

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Electromyographic Response to TsDcs in CNSLBP
NCT06712992 ACTIVE_NOT_RECRUITING NA
Electrical Currents on Hypoalgesia
NCT01950728 COMPLETED NA