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

NCT02832232 | Unknown Phase 2

• 1 other identifier: P16/068
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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).

Conditions

Neck Pain

Keywords

Physiotherapy; Manual Therapy; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in Neck disability

  Baseline -3 weeks - 3 months

• Changes in Range of motion

  Baseline -3 weeks - 3 months

• Patient perception of change at short term

  3 weeks after recruitment

• Patient perception of change at middle term

  3 weeks after discharge

• Headache disability at short term

  3 weeks after recruitment

Study Arms (3)

Mobilization Group

EXPERIMENTAL

translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy

Other: translational dorsal glide mobilization technique grade III; Other: Control Group

Maintained pressure Group

EXPERIMENTAL

pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy

Other: pressure maintained suboccipital Inhibition technique; Other: Control Group

Control Group

OTHER

Protocolized Physiotherapy

Other: Control Group

Interventions

translational dorsal glide mobilization technique grade III OTHER

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.

Mobilization Group

pressure maintained suboccipital Inhibition technique OTHER

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.

Maintained pressure Group

Control Group OTHER

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

Control Group; Maintained pressure Group; Mobilization Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

Catalan Institut of Health - Sant Ildefons Rehabilitation Center

Cornellà de Llobregat, Barcelona, 08940, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 33076707 DERIVED

• 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.

  PMID: 28870191 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Vanessa González, M.Sc.

CONTACT

646619704; vgr1980@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: August 31, 2017

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)