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

NCT ID: NCT02832232

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-10-31

Brief Summary

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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

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Conditions

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Neck Pain

Keywords

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Physiotherapy Manual Therapy Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mobilization Group

translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy

Group Type EXPERIMENTAL

translational dorsal glide mobilization technique grade III

Intervention Type 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.

Control Group

Intervention Type OTHER

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

Maintained pressure Group

pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy

Group Type EXPERIMENTAL

pressure maintained suboccipital Inhibition technique

Intervention Type 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.

Control Group

Intervention Type OTHER

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

Control Group

Protocolized Physiotherapy

Group Type OTHER

Control Group

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Control Group

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catalan Institut of Health - Sant Ildefons Rehabilitation Center

Cornellà de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Vanessa González, M.Sc.

Role: CONTACT

Phone: 646619704

Email: [email protected]

Facility Contacts

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Vanessa González, M.Sc.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33076707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28870191 (View on PubMed)

Other Identifiers

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P16/068

Identifier Type: -

Identifier Source: org_study_id