Clinical trial NCT02832232: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neck Pain
Keywords: Physiotherapy
Manual Therapy
Neck Pain
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Changes in Pain intensity
timeFrame: Baseline -3 weeks - 3 months
Secondary outcomes:
measure: Changes in Neck disability
timeFrame: Baseline -3 weeks - 3 months
measure: Changes in Range of motion
timeFrame: Baseline -3 weeks - 3 months
measure: Patient perception of change at short term
timeFrame: 3 weeks after recruitment
measure: Patient perception of change at middle term
timeFrame: 3 weeks after discharge
measure: Headache disability at short term
timeFrame: 3 weeks after recruitment
measure: Headache disability at middle term
timeFrame: 3 weeks after discharge
Other outcomes:
Locations:
city: Cornella de Llobregat
country: Spain
facility: Catalan Institut of Health - Sant Ildefons Rehabilitation Center
state: Barcelona
Study officials:
References:
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.
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.