Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain
Primary Purpose
Neck Pain
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
translational dorsal glide mobilization technique grade III
pressure maintained suboccipital Inhibition technique
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Physiotherapy, Manual Therapy, Neck Pain
Eligibility 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.
Sites / Locations
- Catalan Institut of Health - Sant Ildefons Rehabilitation CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Mobilization Group
Maintained pressure Group
Control Group
Arm Description
translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy
pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy
Protocolized Physiotherapy
Outcomes
Primary Outcome Measures
Changes in Pain intensity
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
Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)
Changes in Range of motion
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
Measure instrument: Global Rating of Change scale (GROC-scale)
Patient perception of change at middle term
Measure instrument: Global Rating of Change scale (GROC-scale)
Headache disability at short term
Measure instrument: Headache impact test (HIT-6)
Headache disability at middle term
Measure instrument: Headache impact test (HIT-6)
Full Information
NCT ID
NCT02832232
First Posted
July 6, 2016
Last Updated
August 30, 2017
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
1. Study Identification
Unique Protocol Identification Number
NCT02832232
Brief Title
Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Physiotherapy, Manual Therapy, Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobilization Group
Arm Type
Experimental
Arm Description
translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy
Arm Title
Maintained pressure Group
Arm Type
Experimental
Arm Description
pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy
Arm Title
Control Group
Arm Type
Other
Arm Description
Protocolized Physiotherapy
Intervention Type
Other
Intervention Name(s)
translational dorsal glide mobilization technique grade III
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
pressure maintained suboccipital Inhibition technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.
Primary Outcome Measure Information:
Title
Changes in Pain intensity
Description
Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)
Time Frame
Baseline -3 weeks - 3 months
Secondary Outcome Measure Information:
Title
Changes in Neck disability
Description
Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)
Time Frame
Baseline -3 weeks - 3 months
Title
Changes in Range of motion
Description
Changes from Baseline in Range of Motion at 3 weeks and 3 months. Measure instrument: Cervical Range of Motion (CROM) device.
Time Frame
Baseline -3 weeks - 3 months
Title
Patient perception of change at short term
Description
Measure instrument: Global Rating of Change scale (GROC-scale)
Time Frame
3 weeks after recruitment
Title
Patient perception of change at middle term
Description
Measure instrument: Global Rating of Change scale (GROC-scale)
Time Frame
3 weeks after discharge
Title
Headache disability at short term
Description
Measure instrument: Headache impact test (HIT-6)
Time Frame
3 weeks after recruitment
Title
Headache disability at middle term
Description
Measure instrument: Headache impact test (HIT-6)
Time Frame
3 weeks after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa González, M.Sc.
Phone
646619704
Email
vgr1980@gmail.com
Facility Information:
Facility Name
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
City
Cornella de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa González, M.Sc.
Phone
646619704
Email
vgr1980@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33076707
Citation
Gonzalez-Rueda V, Lopez-de-Celis C, Bueno-Gracia E, Rodriguez-Sanz J, Perez-Bellmunt A, Barra-Lopez ME, Hidalgo Garcia C. "Short- and mid-term effects of adding upper cervical manual therapy to a conventional physical therapy program in patients with chronic mechanical neck pain. Randomized controlled clinical trial.". Clin Rehabil. 2021 Mar;35(3):378-389. doi: 10.1177/0269215520965054. Epub 2020 Oct 19.
Results Reference
derived
PubMed Identifier
28870191
Citation
Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
Results Reference
derived
Learn more about this trial
Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain
We'll reach out to this number within 24 hrs