AzTrials
AzTrials

PainNCT03531541

Hypoalgesic Effect of Electrical Current and Cervical Manipulation

A study testing Application of TENS and CJM in people with Pain, run by Universidade Federal de Sao Carlos at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Application of TENS and CJM
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
2 sitesBrazil
Study dates
10 May 2018to 27 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • previous spinal surgeries
  • spinal canal stenosis
  • vertebral fracture
  • spondylolisthesis
  • cancer
  • acute infections
Show all 26Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Centro Universitário Católico Salesiano Auxilium de Lins

    Lins, São Paulo, 16400-505

  • Ufscar - Universidade Federal de São Carlos

    São Carlos, São Paulo, 13565-905

Other trials in Brazil

About this study

Official title: Transcutaneous Electrical Nerve Stimulation and Cervical Joint Manipulation on Pressure Pain Threshold

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

Read the detailed description

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
Pain
Being tested
Application of TENS, CJM, Placebo TENS, Placebo CJM
Keywords
TENS, cervical manipulation, pressure pain
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Application of TENSDevice

    Also called Transcutaneous Electrical Nerve Stimulation (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.

  • CJMDevice

    Also called Cervical Joint Manipulation

    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 TENSDevice

    Also called Placebo Transcutaneous Electrical Nerve Stimulation (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

  • Placebo CJMDevice

    Also called Placebo Cervical Joint Manipulation

    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.

Study groups in NCT03531541
Study groupRoleWhat they receive
active TENS and CJMActive comparatorThe 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).
Receives: Device: Application of TENS; Device: CJM
placebos TENS and CJMPlacebo comparatorThe 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
Receives: Device: Placebo TENS; Device: Placebo CJM
placebo TENS and active CJMActive comparatorThe 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.
Receives: Device: CJM; Device: Placebo TENS
active TENS and placebo CJMActive comparatorThe 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.
Receives: Device: Application of TENS; Device: Placebo CJM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 minute after the end of the intervention.

Secondary outcomes (3)

  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.

    Measured: 20 minutes after the end of the intervention

  2. Pressure Pain Threshold of the tibialis anterior muscle

    For the PPT assessment over the tibialis anterior muscle of the dominant side, the patient will be positioned supine on a stretcher with the knees flexed at 90°. The examiner will place the pressure algometer 5 cm below the tibial tuberosity and 2.5 cm laterally to the tibial tuberosity over the tibialis anterior muscle.

    Measured: 1 minute after the end of the intervention.

  3. Pressure Pain Threshold of the tibialis anterior muscle

    For the PPT assessment over the tibialis anterior muscle of the dominant side, the patient will be positioned supine on a stretcher with the knees flexed at 90°. The examiner will place the pressure algometer 5 cm below the tibial tuberosity and 2.5 cm laterally to the tibial tuberosity over the tibialis anterior muscle.

    Measured: 20 minutes after the end of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2018
  2. Study start10 May 2018
  3. Primary completion20 Nov 2018
  4. Study completion27 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03531541
Sponsor's protocol ID
U1111-1212-5389
Status last verified
Feb 2019
First submitted
24 Apr 2018
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10215661

  • 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.

    PubMed 5320816

  • 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.

    PubMed 832169

  • 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.

    PubMed 7250283

  • 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.

    PubMed 24254493

  • 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.

    PubMed 23900134

  • 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.

    PubMed 17988952

  • 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.

    PubMed 12620611

  • 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.

    PubMed 1686080

  • 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.

    PubMed 16396728

  • 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.

    PubMed 19027344

  • 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.

    PubMed 16182019

  • 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.

    PubMed 12021744

  • 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.

    PubMed 25609853

  • 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.

    PubMed 11327789

Questions about this trial

What is this clinical trial studying?

A study testing Application of TENS and CJM in people with Pain, run by Universidade Federal de Sao Carlos at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pressure Pain Threshold of the posterior region of the forearm (time frame: 1 minute after the end of the intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03531541, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in