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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832232
• Other study ID #: P16/068
• Status: Recruiting
• Phase: Phase 2
• First received: July 6, 2016
• Last updated: August 30, 2017
• Start date: July 2016
• Est. completion date: October 2019

Study information

• Verified date: May 2016
• Source: Jordi Gol i Gurina Foundation
• Contact: Vanessa González, M.Sc.
• Phone: 646619704
• Email: vgr1980[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

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

Locations

Country	Name	City	State
Spain	Catalan Institut of Health - Sant Ildefons Rehabilitation Center	Cornella de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Jordi Gol i Gurina Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Pain intensity	Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)	Baseline -3 weeks - 3 months
Secondary	Changes in Neck disability	Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)	Baseline -3 weeks - 3 months
Secondary	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.	Baseline -3 weeks - 3 months
Secondary	Patient perception of change at short term	Measure instrument: Global Rating of Change scale (GROC-scale)	3 weeks after recruitment
Secondary	Patient perception of change at middle term	Measure instrument: Global Rating of Change scale (GROC-scale)	3 weeks after discharge
Secondary	Headache disability at short term	Measure instrument: Headache impact test (HIT-6)	3 weeks after recruitment
Secondary	Headache disability at middle term	Measure instrument: Headache impact test (HIT-6)	3 weeks after discharge