Chronic Mechanical Neck PainNCT04777890
Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain
A study testing suboccipital inhibition, INYBI and INYBI + upper cervical manipulation in people with Chronic Mechanical Neck Pain, run by Juan José Arjona Retamal at 1 site in Spain.
Trial summary
The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Chronic Mechanical Neck Pain
- What is being tested?
- suboccipital inhibition, INYBI and INYBI + upper cervical manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 20 Mar 2021to 7 Jun 2021
- Phase
- Interventional
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants aged between 18 and 40 all diagnosed with chronic mechanic cervical pain with an evolution of at least 3 months and who show pain that increases with maintained postures, during movement and during spinal muscles palpation.
Who cannot join
- participants that can't read and/or fill in the informed consent, either due to a language and/or cognition alteration or age-related factors.
- subjects with psychological pathologies, such as hysteria, depression or anxiety.
- subjects that have received a manual treatment two months before the beginning of the clinical trial.
- subjects who have been recommended by a physician or an anesthetist to receive any type of analgesic, anti-inflammatory or neuromodulator medication, such as antidepressants, antiepileptics and benzodiazepines. If the patient took in this type of medication in an occasional way 72 hours before the beginning of the study, he/she could participate.
- the treatment and assessment techniques will be avoided if: fear to vertebral manipulation in the upper cervical area or positive Klein test and other integrity test of the vertebral artery, positive cervical instability test and positive Spurling test (foraminal compression test).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial
The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine which of these techniques is the most effective in the variables studied. In order to do so, 96 subjects participated in the study, being assigned to the 3 intervention groups. We expected the combined treatment (INYBI instrument + upper cervical manipulation) to be the one to produce the best results.
- Conditions
- Chronic Mechanical Neck Pain
- Being tested
- suboccipital inhibition, INYBI, INYBI + upper cervical manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suboccipital inhibitionOther
The therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period.
INYBIOther
The therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency.
INYBI + upper cervical manipulationOther
The participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out
| Study group | Role | What they receive |
|---|---|---|
| suboccipital inhibition technique group | Active comparator | Not described Receives: Other: suboccipital inhibition |
| INYBI group | Experimental | Participants in this group will be treated with the INYBI, an instrument designed for treating the suboccipital area, in a more precise way than the manual technique. Receives: Other: INYBI |
| combined treatment group | Experimental | Participants in this group will be first treated with the INYBI and then receive an upper cervical manipulation Receives: Other: INYBI + upper cervical manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in patients' cervical functionality between baseline and follow-up period.
cervical functionality is measured with the Neck Disability Index
Measured: Baseline and two weeks after the second intervention.
Secondary outcomes (3)
Changes in patients' cervical mobility between baseline and follow-up periods.
The movements that will be measured with the CROM® are: flexion, extension, right and left rotation, right and left side-bending.
Measured: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pressure pain threshold between baseline and follow-up periods.
The pressure pain threshold will be measured with an algometer (Mechanical Algometer Pain Test® de Wagner Instrument, USA) in the suboccipital and trapezius muscles (both left and right).
Measured: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pain due to movement between baseline and follow-up periods.
The movements that will be measured with the visual analogue scale (VAS) are: flexion, extension, right and left rotation, right and left side-bending.
Measured: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start20 Mar 2021
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Mechanical 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan José Arjona Retamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan José Arjona Retamal, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777890
- Sponsor's protocol ID
- University Rey Juan Carlos
- Status last verified
- Jun 2021
- First submitted
- 20 Feb 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berolo S, Wells RP, Amick BC 3rd. Musculoskeletal symptoms among mobile hand-held device users and their relationship to device use: A preliminary study in a Canadian university population. Appl Ergon. 2011 Jan;42(2):371-8. doi: 10.1016/j.apergo.2010.08.010. Epub 2010 Sep 15.
PubMed 20833387Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
PubMed 25659245Cote P, Cassidy DJ, Carroll LJ, Kristman V. The annual incidence and course of neck pain in the general population: a population-based cohort study. Pain. 2004 Dec;112(3):267-273. doi: 10.1016/j.pain.2004.09.004.
PubMed 15561381Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
PubMed 21979312Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
PubMed 26852024Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.
PubMed 25440210Espi-Lopez GV, Zurriaga-Llorens R, Monzani L, Falla D. The effect of manipulation plus massage therapy versus massage therapy alone in people with tension-type headache. A randomized controlled clinical trial. Eur J Phys Rehabil Med. 2016 Oct;52(5):606-617. Epub 2016 Mar 18.
PubMed 26989818Field, A. Discovering statistics using IBM SPSS statistics. Fourth Edition. London. Sage; 2013. pp. 473-474.
Galindez-Ibarbengoetxea X, Setuain I, Ramirez-Velez R, Andersen LL, Gonzalez-Izal M, Jauregi A, Izquierdo M. Short-term effects of manipulative treatment versus a therapeutic home exercise protocol for chronic cervical pain: A randomized clinical trial. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):133-145. doi: 10.3233/BMR-169723.
PubMed 28826170Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
PubMed 24482302Jimenez-Sanchez S, Fernandez-de-Las-Penas C, Carrasco-Garrido P, Hernandez-Barrera V, Alonso-Blanco C, Palacios-Cena D, Jimenez-Garcia R. Prevalence of chronic head, neck and low back pain and associated factors in women residing in the Autonomous Region of Madrid (Spain). Gac Sanit. 2012 Nov-Dec;26(6):534-40. doi: 10.1016/j.gaceta.2011.10.012. Epub 2012 Feb 18.
PubMed 22342049Jussila L, Paananen M, Nayha S, Taimela S, Tammelin T, Auvinen J, Karppinen J. Psychosocial and lifestyle correlates of musculoskeletal pain patterns in adolescence: a 2-year follow-up study. Eur J Pain. 2014 Jan;18(1):139-46. doi: 10.1002/j.1532-2149.2013.00353.x. Epub 2013 Jul 12.
PubMed 23853106Lee SP, Hsu YT, Bair B, Toberman M, Chien LC. Gender and posture are significant risk factors to musculoskeletal symptoms during touchscreen tablet computer use. J Phys Ther Sci. 2018 Jun;30(6):855-861. doi: 10.1589/jpts.30.855. Epub 2018 Jun 12.
PubMed 29950780Medina i Mirapeix, F., Mantilla-Herrador, J. and Meseguer-Henajeros, A.B. (2000): "Guía de práctica clínica para el tratamiento y seguimiento fisioterápico de la cervicalgia mecánica", Fisioterapia, 22(S2), pp. 33-46.
Namwongsa S, Puntumetakul R, Neubert MS, Boucaut R. Factors associated with neck disorders among university student smartphone users. Work. 2018;61(3):367-378. doi: 10.3233/WOR-182819.
PubMed 30373996
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Instrumental, Manipulative and Soft Tissue Approaches for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04777890
- Acronym / sponsor ID
- University Rey Juan Carlos
- Conditions
- Chronic Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Juan José Arjona RetamalUniversity, hospital or other
- Study start
- 20 Mar 2021 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 2 Mar 2021 (actual)
- 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.
The aim of the study is to compare the effectiveness between the suboccipital inhibition technique, the suboccipital inhibition carried out with the INYBI instrument and the suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients with chronic mechanic cervicalgia, and to determine which of these techniques is the most effective in the variables studied. In order to do so, 96 subjects participated in the study, being assigned to the 3 intervention groups. We expected the combined treatment (INYBI instrument + upper cervical manipulation) to be the one to produce the best results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| suboccipital inhibition technique group | Active comparator | Other: suboccipital inhibition |
| INYBI group | Experimental | Other: INYBIParticipants in this group will be treated with the INYBI, an instrument designed for treating the suboccipital area, in a more precise way than the manual technique. |
| combined treatment group | Experimental | Other: INYBI + upper cervical manipulationParticipants in this group will be first treated with the INYBI and then receive an upper cervical manipulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants aged between 18 and 40 all diagnosed with chronic mechanic cervical pain with an evolution of at least 3 months and who show pain that increases with maintained postures, during movement and during spinal muscles palpation.
Key exclusion criteria (5 listed)
- participants that can't read and/or fill in the informed consent, either due to a language and/or cognition alteration or age-related factors.
- subjects with psychological pathologies, such as hysteria, depression or anxiety.
- subjects that have received a manual treatment two months before the beginning of the clinical trial.
- subjects who have been recommended by a physician or an anesthetist to receive any type of analgesic, anti-inflammatory or neuromodulator medication, such as antidepressants, antiepileptics and benzodiazepines. If the patient took in this type of medication in an occasional way 72 hours before the beginning of the study, he/she could participate.
- the treatment and assessment techniques will be avoided if: fear to vertebral manipulation in the upper cervical area or positive Klein test and other integrity test of the vertebral artery, positive cervical instability test and positive Spurling test (foraminal compression test).
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 |
|---|---|---|
| suboccipital inhibitionThe therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period. | Other | suboccipital inhibition technique group |
| INYBIThe therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency. | Other | INYBI group |
| INYBI + upper cervical manipulationThe participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out | Other | combined treatment group |
Primary outcome
Changes in patients' cervical functionality between baseline and follow-up period.
Time frame: Baseline and two weeks after the second intervention.
cervical functionality is measured with the Neck Disability Index
3 secondary outcomes
Changes in patients' cervical mobility between baseline and follow-up periods.
Time frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pressure pain threshold between baseline and follow-up periods.
Time frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Changes in patients' pain due to movement between baseline and follow-up periods.
Time frame: Baseline, 10 minutes after the first intervention, 1 week after the first intervention and 10 minutes after the second intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Background: PubMed 20833387Berolo S, Wells RP, Amick BC 3rd. Musculoskeletal symptoms among mobile hand-held device users and their relationship to device use: A preliminary study in a Canadian university population. Appl Ergon. 2011 Jan;42(2):371-8. doi: 10.1016/j.apergo.2010.08.010. Epub 2010 Sep 15.
- Background: PubMed 25659245Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
- Background: PubMed 15561381Cote P, Cassidy DJ, Carroll LJ, Kristman V. The annual incidence and course of neck pain in the general population: a population-based cohort study. Pain. 2004 Dec;112(3):267-273. doi: 10.1016/j.pain.2004.09.004.
- Background: PubMed 21979312Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.
- Background: PubMed 26852024Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Background: PubMed 25440210Espi-Lopez GV, Gomez-Conesa A, Gomez AA, Martinez JB, Pascual-Vaca AO, Blanco CR. Treatment of tension-type headache with articulatory and suboccipital soft tissue therapy: A double-blind, randomized, placebo-controlled clinical trial. J Bodyw Mov Ther. 2014 Oct;18(4):576-85. doi: 10.1016/j.jbmt.2014.01.001. Epub 2014 Jan 10.
- Background: PubMed 26989818Espi-Lopez GV, Zurriaga-Llorens R, Monzani L, Falla D. The effect of manipulation plus massage therapy versus massage therapy alone in people with tension-type headache. A randomized controlled clinical trial. Eur J Phys Rehabil Med. 2016 Oct;52(5):606-617. Epub 2016 Mar 18.
- BackgroundField, A. Discovering statistics using IBM SPSS statistics. Fourth Edition. London. Sage; 2013. pp. 473-474.
- Background: PubMed 28826170Galindez-Ibarbengoetxea X, Setuain I, Ramirez-Velez R, Andersen LL, Gonzalez-Izal M, Jauregi A, Izquierdo M. Short-term effects of manipulative treatment versus a therapeutic home exercise protocol for chronic cervical pain: A randomized clinical trial. J Back Musculoskelet Rehabil. 2018 Feb 6;31(1):133-145. doi: 10.3233/BMR-169723.
- Background: PubMed 24482302Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, Burstein R, Buchbinder R. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1309-15. doi: 10.1136/annrheumdis-2013-204431. Epub 2014 Jan 30.
- Background: PubMed 22342049Jimenez-Sanchez S, Fernandez-de-Las-Penas C, Carrasco-Garrido P, Hernandez-Barrera V, Alonso-Blanco C, Palacios-Cena D, Jimenez-Garcia R. Prevalence of chronic head, neck and low back pain and associated factors in women residing in the Autonomous Region of Madrid (Spain). Gac Sanit. 2012 Nov-Dec;26(6):534-40. doi: 10.1016/j.gaceta.2011.10.012. Epub 2012 Feb 18.
- Background: PubMed 23853106Jussila L, Paananen M, Nayha S, Taimela S, Tammelin T, Auvinen J, Karppinen J. Psychosocial and lifestyle correlates of musculoskeletal pain patterns in adolescence: a 2-year follow-up study. Eur J Pain. 2014 Jan;18(1):139-46. doi: 10.1002/j.1532-2149.2013.00353.x. Epub 2013 Jul 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suboccipital inhibition, INYBI and INYBI + upper cervical manipulation in people with Chronic Mechanical Neck Pain, run by Juan José Arjona Retamal 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in patients' cervical functionality between baseline and follow-up period. (time frame: Baseline and two weeks after the second intervention.). 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 NCT04777890, which also lists 24 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 15 Jun 2021.