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

August 30, 2017 updated by: Jordi Gol i Gurina Foundation

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 2

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

  • Spain
    • Barcelona
      • Cornella de Llobregat, Barcelona, Spain, 08940
        • Recruiting
        • Catalan Institut of Health - Sant Ildefons Rehabilitation Center
        • Contact:

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline -3 weeks - 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline -3 weeks - 3 months
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.
Baseline -3 weeks - 3 months
Patient perception of change at short term
Time Frame: 3 weeks after recruitment
Measure instrument: Global Rating of Change scale (GROC-scale)
3 weeks after recruitment
Patient perception of change at middle term
Time Frame: 3 weeks after discharge
Measure instrument: Global Rating of Change scale (GROC-scale)
3 weeks after discharge
Headache disability at short term
Time Frame: 3 weeks after recruitment
Measure instrument: Headache impact test (HIT-6)
3 weeks after recruitment
Headache disability at middle term
Time Frame: 3 weeks after discharge
Measure instrument: Headache impact test (HIT-6)
3 weeks after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

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

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

July 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

July 6, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (ESTIMATE)

July 14, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16/068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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