- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03541538
Hypoalgesic Effect of Cervical Manipulation
July 11, 2020 updated by: Jonathan Daniel Telles, Universidade Federal de Sao Carlos
Hypoalgesic Effects of Specific vs Non-specific Cervical Manipulation in Healthy Subjects
This study evaluates the hypoalgesic effect of global and specific cervical joint manipulation in healthy individuals.
At first the participants received one of the interventions and after 48 hours, the other.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cervical Joint Manipulation (CJM) are often used for pain treatment.
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.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
São Carlos, São Paulo, Brazil, 13565-905
- Ufscar - Universidade Federal de São Carlos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy subjects of both sexes
- without pain complaints in 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
- rheumatic diseases
- metabolic diseases
- cardiorespiratory diseases
- smoking injury
- musculoskeletal injury
- 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 joint manipulation treatments
- aversion to cervical joint manipulation
- positivity in the vertebral artery test
- headache in the last seven days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Global manipulation
Manual therapy performed in the cervical region in a non-specific way.
|
The therapist positioned himself at the head of the stretcher and with one hand supported the side of the participant's face.
With the other hand supported the opposite face of the same and then performed contralateral rotation of the cervical and a slight traction to the tissue barrier to perform the manipulation impulse of high speed and short amplitude in rotation.
The procedure was carried out bilaterally.
|
Experimental: Especific manipulation
manual therapy performed specifically on the C6-7 segment
|
The therapist positioned himself at the head of the stretcher and with one hand kept the middle phalange of the second finger laterally on the articular processes of the C6-7 vertebrae.
With the contralateral hand he supported the opposing face of the participant by performing a tilt up to the C6-7 segment and contralateral rotation up to the tissue barrier to carry out the impulse quickly and short.
The procedure was carried out bilaterally.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold at the posterior region of the forearm
Time Frame: 1 minute after the end of the intervention.
|
The subjects were placed supine on a stretcher with their elbows fully extended and the anterior portion of the forearm resting on the stretcher.
Subjects were instructed to keep their eyes closed during attempts.
The examiner used 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, keeping the forearm in pronation.
The pressure was then applied perpendicular to the skin at a rate of 40kPa / s using a 1cm2 flat circular probe covered with 1mm of rubber to prevent any skin pain caused by sharp metal edges.
|
1 minute after the end of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard E Liebano, Dr., Universidade Federal de São Carlos - UFScar
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Costa LO, Maher CG, Latimer J, Ferreira PH, Ferreira ML, Pozzi GC, Freitas LM. Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine (Phila Pa 1976). 2008 Oct 15;33(22):2459-63. doi: 10.1097/BRS.0b013e3181849dbe.
- 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.
- 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.
- 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.
- 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.
- 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.
- Welch A, Boone R. Sympathetic and parasympathetic responses to specific diversified adjustments to chiropractic vertebral subluxations of the cervical and thoracic spine. J Chiropr Med. 2008 Sep;7(3):86-93. doi: 10.1016/j.jcm.2008.04.001.
- 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.
- 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.
- George SZ, Bishop MD, Bialosky JE, Zeppieri G Jr, Robinson ME. Immediate effects of spinal manipulation on thermal pain sensitivity: an experimental study. BMC Musculoskelet Disord. 2006 Aug 15;7:68. doi: 10.1186/1471-2474-7-68.
- 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.
- Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.
- Bishop MD, Beneciuk JM, George SZ. Immediate reduction in temporal sensory summation after thoracic spinal manipulation. Spine J. 2011 May;11(5):440-6. doi: 10.1016/j.spinee.2011.03.001. Epub 2011 Apr 3.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Staud R. Treatment of fibromyalgia and its symptoms. Expert Opin Pharmacother. 2007 Aug;8(11):1629-42. doi: 10.1517/14656566.8.11.1629.
- 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.
- 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.
- Almay BG, Johansson F, von Knorring L, Sakurada T, Terenius L. Long-term high frequency transcutaneous electrical nerve stimulation (hi-TNS) in chronic pain. Clinical response and effects on CSF-endorphins, monoamine metabolites, substance P-like immunoreactivity (SPLI) and pain measures. J Psychosom Res. 1985;29(3):247-57. doi: 10.1016/0022-3999(85)90051-0.
- Bergmann TF. Short lever, specific contact articular chiropractic technique. J Manipulative Physiol Ther. 1992 Nov-Dec;15(9):591-5.
- Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF. Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of nonspecific chronic low-back pain subjects. Man Ther. 2010 Oct;15(5):469-75. doi: 10.1016/j.math.2010.03.012. Epub 2010 May 5.
- Descarreaux M, Blouin JS, Drolet M, Papadimitriou S, Teasdale N. Efficacy of preventive spinal manipulation for chronic low-back pain and related disabilities: a preliminary study. J Manipulative Physiol Ther. 2004 Oct;27(8):509-14. doi: 10.1016/j.jmpt.2004.08.003.
- Degenhardt BF, Darmani NA, Johnson JC, Towns LC, Rhodes DC, Trinh C, McClanahan B, DiMarzo V. Role of osteopathic manipulative treatment in altering pain biomarkers: a pilot study. J Am Osteopath Assoc. 2007 Sep;107(9):387-400.
- Dishman JD, Cunningham BM, Burke J. Comparison of tibial nerve H-reflex excitability after cervical and lumbar spine manipulation. J Manipulative Physiol Ther. 2002 Jun;25(5):318-25. doi: 10.1067/mmt.2002.124420.
- Fernandez-de-Las-Penas C. Clinical evaluation of cervicogenic headache: a clinical perspective. J Man Manip Ther. 2008;16(2):81. doi: 10.1179/106698108790818440. No abstract available.
- Fernandez-de-Las-Penas C, Alonso-Blanco C, Cleland JA, Rodriguez-Blanco C, Alburquerque-Sendin F. Changes in pressure pain thresholds over C5-C6 zygapophyseal joint after a cervicothoracic junction manipulation in healthy subjects. J Manipulative Physiol Ther. 2008 Jun;31(5):332-7. doi: 10.1016/j.jmpt.2008.04.006.
- Korr IM. Proprioceptors and somatic dysfunction. J Am Osteopath Assoc. 1975 Mar;74(7):638-50. No abstract available.
- Leffler AS, Hansson P, Kosek E. Somatosensory perception in a remote pain-free area and function of diffuse noxious inhibitory controls (DNIC) in patients suffering from long-term trapezius myalgia. Eur J Pain. 2002;6(2):149-59. doi: 10.1053/eujp.2001.0312.
- Malisza KL, Gregorash L, Turner A, Foniok T, Stroman PW, Allman AA, Summers R, Wright A. Functional MRI involving painful stimulation of the ankle and the effect of physiotherapy joint mobilization. Magn Reson Imaging. 2003 Jun;21(5):489-96. doi: 10.1016/s0730-725x(03)00074-2.
- Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. doi: 10.1093/ptj/78.2.160.
- de Oliveira RF, Liebano RE, Costa Lda C, Rissato LL, Costa LO. Immediate effects of region-specific and non-region-specific spinal manipulative therapy in patients with chronic low back pain: a randomized controlled trial. Phys Ther. 2013 Jun;93(6):748-56. doi: 10.2522/ptj.20120256. Epub 2013 Feb 21.
- Schneider M. Changes in pressure pain sensitivity in latent myofascial trigger points in the upper trapezius muscle after a cervical spine manipulation in pain-free subjects. J Manipulative Physiol Ther. 2008 Mar;31(3):251; author reply 251-2. doi: 10.1016/j.jmpt.2008.02.011. No abstract available.
- Sluka KA, Wright A. Knee joint mobilization reduces secondary mechanical hyperalgesia induced by capsaicin injection into the ankle joint. Eur J Pain. 2001;5(1):81-7. doi: 10.1053/eujp.2000.0223.
- Vicenzino B, Collins D, Benson H, Wright A. An investigation of the interrelationship between manipulative therapy-induced hypoalgesia and sympathoexcitation. J Manipulative Physiol Ther. 1998 Sep;21(7):448-53.
- Vigotsky AD, Bruhns RP. Corrigendum to "The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review". Pain Res Treat. 2017;2017:1535473. doi: 10.1155/2017/1535473. Epub 2017 Oct 26.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2018
Primary Completion (Actual)
June 20, 2018
Study Completion (Actual)
July 20, 2018
Study Registration Dates
First Submitted
May 17, 2018
First Submitted That Met QC Criteria
May 17, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
July 14, 2020
Last Update Submitted That Met QC Criteria
July 11, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- U1111-1214-1243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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