NCT03541538

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2018

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

May 17, 2018

Last Update Submit

July 11, 2020

Conditions

Keywords

joint manipulationcervicalpressure painmanual therapy

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold at the posterior region of the forearm

    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.

Study Arms (2)

Global manipulation

ACTIVE COMPARATOR

Manual therapy performed in the cervical region in a non-specific way.

Device: Global manipulation

Especific manipulation

EXPERIMENTAL

manual therapy performed specifically on the C6-7 segment

Device: Especific manipulation

Interventions

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.

Global manipulation

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.

Especific manipulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subjects of both sexes
  • without pain complaints in 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
  • rheumatic diseases
  • metabolic diseases
  • cardiorespiratory diseases
  • smoking injury
  • musculoskeletal injury
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufscar - Universidade Federal de SĂ£o Carlos

SĂ£o Carlos, SĂ£o Paulo, 13565-905, Brazil

Location

Related Publications (46)

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    PMID: 2411923BACKGROUND
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    PMID: 1469343BACKGROUND
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    PMID: 19027342BACKGROUND
  • 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.

    PMID: 20447857BACKGROUND
  • 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.

    PMID: 21463970BACKGROUND
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    PMID: 15195039BACKGROUND
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    PMID: 18923324BACKGROUND
  • 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.

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  • 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.

    PMID: 15510094BACKGROUND
  • 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.

    PMID: 17908831BACKGROUND
  • 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.

    PMID: 12072852BACKGROUND
  • 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: 16182019BACKGROUND
  • 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: 19027344BACKGROUND
  • 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.

    PMID: 19119391BACKGROUND
  • 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.

    PMID: 18558274BACKGROUND
  • 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: 17612359BACKGROUND
  • 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: 16396728BACKGROUND
  • 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: 25284739BACKGROUND
  • 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.

    PMID: 16911795BACKGROUND
  • 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: 28912629BACKGROUND
  • Korr IM. Proprioceptors and somatic dysfunction. J Am Osteopath Assoc. 1975 Mar;74(7):638-50. No abstract available.

    PMID: 124754BACKGROUND
  • 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.

    PMID: 11900475BACKGROUND
  • 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: 12725850BACKGROUND
  • 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: 21144659BACKGROUND
  • 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: 23650092BACKGROUND
  • 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.

    PMID: 12878258BACKGROUND
  • 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: 15987503BACKGROUND
  • 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.

    PMID: 9474108BACKGROUND
  • 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.

    PMID: 23431209BACKGROUND
  • 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: 24674816BACKGROUND
  • Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.

    PMID: 14589467BACKGROUND
  • 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: 11174689BACKGROUND
  • 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.

    PMID: 18394505BACKGROUND
  • 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: 24867897BACKGROUND
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    PMID: 17685881BACKGROUND
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    PMID: 25844555BACKGROUND
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Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard E Liebano, Dr.

    Universidade Federal de SĂ£o Carlos - UFScar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Examiner 1 will receive the blinding outcome will be asked: "Which intervention does the patienth as received: global manipulation or especific manipulation" Their responses to these questions will be recorded and used to measure the adequacy of participants and examiners.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants received two interventions randomly at two times: global manipulation (GM) and specific manipulation (MS)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

June 20, 2018

Primary Completion

June 20, 2018

Study Completion

July 20, 2018

Last Updated

July 14, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations