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

Phase 2

• Conditions: Neck Pain
• Interventions: Other: translational dorsal glide mobilization technique grade III; Other: pressure maintained suboccipital Inhibition technique; Other: Control Group

• Registration Number: NCT02832232
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study Start: 2016-07
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-14
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31
• Primary Completion: 2018-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobilization Group	Control Group	translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy
Maintained pressure Group	Control Group	pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy
Mobilization Group	translational dorsal glide mobilization technique grade III	translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy
Maintained pressure Group	pressure maintained suboccipital Inhibition technique	pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy
Control Group	Control Group	Protocolized Physiotherapy

Primary Outcome Measures

Name	Time	Method
Changes in Pain intensity	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

Name	Time	Method
Patient perception of change at middle term	3 weeks after discharge	Measure instrument: Global Rating of Change scale (GROC-scale)
Headache disability at short term	3 weeks after recruitment	Measure instrument: Headache impact test (HIT-6)
Changes in Neck disability	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	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	3 weeks after recruitment	Measure instrument: Global Rating of Change scale (GROC-scale)
Headache disability at middle term	3 weeks after discharge	Measure instrument: Headache impact test (HIT-6)

Trial Locations

Locations (1)

Catalan Institut of Health - Sant Ildefons Rehabilitation Center; 🇪🇸 Cornella de Llobregat, Barcelona, Spain