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PainNCT03541538

Hypoalgesic Effect of Cervical Manipulation

A study testing Global manipulation and Especific manipulation in people with Pain, run by Universidade Federal de Sao Carlos at 1 site in Brazil.

Completed

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

Official record
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Trial 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. 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?
Global manipulation and Especific manipulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteBrazil
Study dates
20 Jun 2018to 20 Jul 2018
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 of both sexes
  • without pain complaints in the last 90 days

Who cannot join

  • previous spinal surgeries
  • spinal canal stenosis
  • vertebral fracture
  • spondylolisthesis
  • cancer
  • acute infections
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Ufscar - Universidade Federal de São Carlos

    São Carlos, São Paulo, 13565-905

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Conditions
Pain
Being tested
Global manipulation, Especific manipulation
Keywords
joint manipulation, cervical, pressure pain, manual therapy
Medical subject headings
Pain

What participants receive

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

  • Global manipulationDevice

    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.

  • Especific manipulationDevice

    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.

Study groups in NCT03541538
Study groupRoleWhat they receive
Global manipulationActive comparatorManual therapy performed in the cervical region in a non-specific way.
Receives: Device: Global manipulation
Especific manipulationExperimentalmanual therapy performed specifically on the C6-7 segment
Receives: Device: Especific manipulation

What is being measured

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

  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.

    Measured: 1 minute 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 posted30 May 2018
  2. Study start20 Jun 2018
  3. Primary completion20 Jun 2018
  4. Study completion20 Jul 2018

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
Crossover
Model description
Participants received two interventions randomly at two times: global manipulation (GM) and specific manipulation (MS)
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03541538
Sponsor's protocol ID
U1111-1214-1243
Status last verified
Jul 2020
First submitted
17 May 2018
Last updated
14 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 2411923

  • Bergmann TF. Short lever, specific contact articular chiropractic technique. J Manipulative Physiol Ther. 1992 Nov-Dec;15(9):591-5.

    PubMed 1469343

  • 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.

    PubMed 19027342

  • 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.

    PubMed 20447857

  • 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.

    PubMed 21463970

  • 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.

    PubMed 15195039

  • 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.

    PubMed 22296867

  • 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.

    PubMed 18923324

  • 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

  • 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.

    PubMed 15510094

  • 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.

    PubMed 17908831

  • 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.

    PubMed 12072852

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Global manipulation and Especific manipulation in people with Pain, run by Universidade Federal de Sao Carlos at 1 site 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 24 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 at 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 NCT03541538, which also lists 46 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 14 Jul 2020.

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