Neck PainPhase 2NCT02832232
Specific Manual Approach to the Suboccipital Area on Patients With Chronic Mechanical Neck Pain
A Phase 2 study testing translational dorsal glide mobilization technique grade III and pressure maintained suboccipital Inhibition technique in people with Neck Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- translational dorsal glide mobilization technique grade III and pressure maintained suboccipital Inhibition technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2016to Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Catalan Institut of Health - Sant Ildefons Rehabilitation Center
Cornellà de Llobregat, Barcelona, 08940
Vanessa González, M.Sc., 646619704, vgr1980@gmail.com
About this study
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
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.
Read more
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
- Being tested
- translational dorsal glide mobilization technique grade III, pressure maintained suboccipital Inhibition technique, Control Group
- Keywords
- Physiotherapy, Manual Therapy, Neck Pain
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
translational dorsal glide mobilization technique grade IIIOther
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 techniqueOther
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 GroupOther
Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.
| Study group | Role | What they receive |
|---|---|---|
| Mobilization Group | Experimental | translational dorsal glide mobilization technique grade III and Protocolized Physiotherapy Receives: Other: translational dorsal glide mobilization technique grade III; Other: Control Group |
| Maintained pressure Group | Experimental | pressure maintained suboccipital inhibition technique and Protocolized Physiotherapy Receives: Other: pressure maintained suboccipital Inhibition technique; Other: Control Group |
| Control Group | Other | Protocolized Physiotherapy Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain intensity
Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)
Measured: Baseline -3 weeks - 3 months
Secondary outcomes (6)
Changes in Neck disability
Changes from Baseline in Neck disability at 3 weeks and 3 months. Measure instrument: Neck disability index questionnaire (NDI)
Measured: Baseline -3 weeks - 3 months
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.
Measured: Baseline -3 weeks - 3 months
Patient perception of change at short term
Measure instrument: Global Rating of Change scale (GROC-scale)
Measured: 3 weeks after recruitment
Patient perception of change at middle term
Measure instrument: Global Rating of Change scale (GROC-scale)
Measured: 3 weeks after discharge
Headache disability at short term
Measure instrument: Headache impact test (HIT-6)
Measured: 3 weeks after recruitment
Headache disability at middle term
Measure instrument: Headache impact test (HIT-6)
Measured: 3 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832232
- Sponsor's protocol ID
- P16/068
- Status last verified
- May 2016
- First submitted
- 6 Jul 2016
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33076707Gonzalez 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.
PubMed 28870191
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02832232
- Acronym / sponsor ID
- P16/068
- Conditions
- Neck Pain
- Keywords
- Physiotherapy, Manual Therapy, Neck Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobilization Group | Experimental | Other: translational dorsal glide mobilization technique grade III, Other: Control Grouptranslational dorsal glide mobilization technique grade III and Protocolized Physiotherapy |
| Maintained pressure Group | Experimental | Other: pressure maintained suboccipital Inhibition technique, Other: Control Grouppressure maintained suboccipital inhibition technique and Protocolized Physiotherapy |
| Control Group | Other | Other: Control GroupProtocolized Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| translational dorsal glide mobilization technique grade IIITranslational 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. | Other | Mobilization Group |
| pressure maintained suboccipital Inhibition techniquePressure 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. | Other | Maintained pressure Group |
| Control GroupProtocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education. | Other | Control Group, Maintained pressure Group, Mobilization Group |
Primary outcome
Changes in Pain intensity
Time frame: Baseline -3 weeks - 3 months
Changes from Baseline in Pain intensity at 3 weeks and 3 months. Measure instrument: Visual Analogue Scale (VAS)
6 secondary outcomes
Changes in Neck disability
Time frame: Baseline -3 weeks - 3 months
Changes in Range of motion
Time frame: Baseline -3 weeks - 3 months
Patient perception of change at short term
Time frame: 3 weeks after recruitment
Patient perception of change at middle term
Time frame: 3 weeks after discharge
Headache disability at short term
Time frame: 3 weeks after recruitment
Headache disability at middle term
Time frame: 3 weeks after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Derived from this study: PubMed 33076707Gonzalez-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.
- Derived from this study: PubMed 28870191Gonzalez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing translational dorsal glide mobilization technique grade III and pressure maintained suboccipital Inhibition technique in people with Neck Pain, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa González, M.Sc. (646619704, vgr1980@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain intensity (time frame: Baseline -3 weeks - 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02832232, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.