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Hypoalgesic Effect of Cervical Manipulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03541538
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan Daniel Telles, Universidade Federal de Sao Carlos

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Device: Global manipulation Device: Especific manipulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants received two interventions randomly at two times: global manipulation (GM) and specific manipulation (MS)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Basic Science
Official Title: Hypoalgesic Effects of Specific vs Non-specific Cervical Manipulation in Healthy Subjects
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : June 20, 2018
Actual Study Completion Date : July 20, 2018
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Global manipulation
Manual therapy performed in the cervical region in a non-specific way.
 Device: Global manipulation
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
 Device: Especific 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541538


Locations
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Brazil
Ufscar - Universidade Federal de São Carlos
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Richard E Liebano, Dr. Universidade Federal de São Carlos - UFScar
More Information
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Additional Information:

Publications:

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Responsible Party: Jonathan Daniel Telles, Principal Investigator, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT03541538    
Other Study ID Numbers: U1111-1214-1243
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Daniel Telles, Universidade Federal de Sao Carlos:
joint manipulation
cervical
pressure pain
manual therapy