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Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain

This study is currently recruiting participants.
Verified May 2016 by Jordi Gol i Gurina Foundation
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832232
First Posted: July 14, 2016
Last Update Posted: August 31, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation
  Purpose

There are different inhibition suboccipital techniques, usually adjuvant of physiotherapy, for treatment of patients with chronic neck pain. In our clinical practice, a favorable effect is observed on patients with chronic neck pain, but there are no published studies evaluating the results of this techniques on pain, mobility and disability.

The objective of this trial is to evaluate if the suboccipital manual techniques, provides further improvement in pain intensity, neck disability, range of motion, on patients with chronic mechanical neck pain and rotation deficit of the upper cervical spine, being treated with physiotherapy. For this purpose, investigators conduct a double-blind (patient and evaluator) randomized controlled trial, in a Public Primary Care Center.

Seventy four subjects will be randomized (computer application) into three groups: Mobilization Group, Maintained pressure Group and Control Group. All the three groups receive the same protocolized physiotherapeutic treatment during three weeks and, additionally, the Mobilization Group receives six sessions (two sessions in a week during three weeks) of translational dorsal glide mobilization technique grade III of the atlanto-occipital joint and the Maintained pressure Group receives six sessions (two sessions in a week during three weeks) of pressure maintained suboccipital Inhibition technique. The Control Group receives the protocolized physiotherapeutic treatment only.

Pain intensity (VAS), Neck Disability Index (NDI), Range of motion (CROM), will be measured at baseline, after treatment period, and three months after discharge from treatment. After discharge for treatment the patient subjective opinion about their evolution will be collected through a Global Rating of Change (GROC) scale, and evaluation of headache disability (HIT-6).


Condition Intervention Phase
Neck Pain Other: translational dorsal glide mobilization technique grade III Other: pressure maintained suboccipital Inhibition technique Other: Control Group Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Manual Specific Approach to the Suboccipital Area on Pain, Range of Motion, Disability and Clinical Significance of Changes on Patients With Chronic Mechanical Neck Pain and Rotation Deficit of the Upper Cervical Spine

Resource links provided by NLM:


Further study details as provided by Jordi Gol i Gurina Foundation:

Primary Outcome Measures:
  • Changes in Pain intensity [ Time Frame: Baseline -3 weeks - 3 months ]
    Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)


Secondary Outcome Measures:
  • Changes in Neck disability [ Time Frame: Baseline -3 weeks - 3 months ]
    Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)

  • Changes in Range of motion [ Time Frame: Baseline -3 weeks - 3 months ]
    Changes from Baseline in Range of Motion at 3 weeks and 3 months. Measure instrument: Cervical Range of Motion (CROM) device.

  • Patient perception of change at short term [ Time Frame: 3 weeks after recruitment ]
    Measure instrument: Global Rating of Change scale (GROC-scale)

  • Patient perception of change at middle term [ Time Frame: 3 weeks after discharge ]
    Measure instrument: Global Rating of Change scale (GROC-scale)

  • Headache disability at short term [ Time Frame: 3 weeks after recruitment ]
    Measure instrument: Headache impact test (HIT-6)

  • Headache disability at middle term [ Time Frame: 3 weeks after discharge ]
    Measure instrument: Headache impact test (HIT-6)


Estimated Enrollment: 78
Study Start Date: July 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobilization Group
translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy
Other: translational dorsal glide mobilization technique grade III

Translational dorsal glide mobilization technique grade III of the atlanto-occipital joint, it is a mobilization technique of Orthopedic Manual therapy according to Kaltenborn-Evjenth concept. The aim is to produce a dorsal glide of the occipital on the atlas, which will be held back by the therapist's hand, producing a stretch component of the suboccipital muscles.

And Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.

Other: Control Group
Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.
Experimental: Maintained pressure Group
pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy
Other: pressure maintained suboccipital Inhibition technique

Pressure maintained suboccipital Inhibition technique is aimed to inhibit the tone of the suboccipital muscles. Although some dorsal occipital glide is produced by the weight of the head itself, the main effect is on the muscles due to dorsally pressure is not added to the occipital.

And Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.

Other: Control Group
Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.
Control Group
Protocolized Physiotherapy
Other: Control Group
Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of chronic mechanical neck pain.
  • Flexion-rotation test positive (less of 32 degrees or 10 degrees difference between the two sides)
  • Sign the informed consent form.

Exclusion Criteria:

  • Presenting one or more positive safety cervical test .
  • Carriers of pacemaker or defibrillators.
  • Previous history of severe trauma to the cervical region of the spine.
  • Inflammatory arthritis.
  • Inability to maintain supine position.
  • Inability to tolerate flexion-rotation test
  • Poor Language and communication skills making difficult to understand the informed consent.
  • Pending litigation or legal claim.
  Contacts and Locations
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): NCT02832232


Contacts
Contact: Vanessa González, M.Sc. 646619704 vgr1980@gmail.com

Locations
Spain
Catalan Institut of Health - Sant Ildefons Rehabilitation Center Recruiting
Cornella de Llobregat, Barcelona, Spain, 08940
Contact: Vanessa González, M.Sc.    646619704    vgr1980@gmail.com   
Sponsors and Collaborators
Jordi Gol i Gurina Foundation
  More Information

Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT02832232     History of Changes
Other Study ID Numbers: P16/068
First Submitted: July 6, 2016
First Posted: July 14, 2016
Last Update Posted: August 31, 2017
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jordi Gol i Gurina Foundation:
Physiotherapy
Manual Therapy
Neck Pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms