Manual TherapiesNCT04156308
Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain
A study testing Osteopathic Manipulative Treatment (OMT) - Temp1 and Combined Exercises in people with Manual Therapies and Neck Pain, run by Escola D'osteopatia De Barcelona at 3 sites in Spain.
Trial summary
In Spain cervical pain affects practically 20% of the population annually, while globally it is estimated that between 22% and 77% of the population will suffer cervical pain at some point in their life. Prevalence increases with age, and is more common in women than in men (1.6: 1). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Manual Therapies, Neck Pain
- What is being tested?
- Osteopathic Manipulative Treatment (OMT) - Temp1 and Combined Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 3 sitesSpain
- Study dates
- Dec 2019to Jun 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The sample will be formed by patients between the ages of 18 and 75 years, who present cervical pain of any intensity and duration, and with a minimum score of 10 points on the Neck Disability Index (NDI)14,15.
Who cannot join
- Patients who present at the time of recruitment other pathologies or elements that may condition cervical pain, such as: acute shoulder tendinopathy, cervical radiculopathy, chronic diseases of general musculoskeletal involvement (Chronic Fatigue Syndrome and / or Fibromyalgia). Similarly, patients suffering from any type of vertiginous syndrome, who have suffered a whiplash in the last year or who are or have been under treatment for cervical pain in the last 3 months will also be excluded.
- The taking of anti-inflammatories by the patient is not taken as a measure of exclusion. If the patient is under pharmacological treatment, it will be recorded and will be taken into account as a co-intervention. However, this treatment will not be modified under any circumstances nor will it be grounds for exclusion from the study.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clinica Osteopatia Horta
Barcelona, 08031
EDGAR SEGARRA CALLIZO, +34.657.559.428, edbandini@gmail.com
EDGAR SEGARRA CALLIZO
IntegroSalus
Cabrils, Barcelona, 08348
Oscar Hernandez Amigo, +34.649.360.771, oscarha@eobosteopatia.com
OSCAR HERNANDEZ AMIGO
AXIS
Sant Sadurní d'Anoia, Barcelona, 08770
DAVID PUERTAS, +34.606.450.462, dpuertas81@gmail.com
DAVID PUERTAS
About this study
Official title: Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial
In Spain cervical pain affects practically 20% of the population annually, while globally it is estimated that between 22% and 77% of the population will suffer cervical pain at some point in their life. Prevalence increases with age, and is more common in women than in men (1.6: 1). Although the natural evolution of cervical pain tends to improve, the rates of recurrence and chronicity are high. And therefore it becomes an anatomical region of interest in relation to the assessment of the effectiveness and / or effectiveness of the osteopathic therapeutic approach. Different studies prove the efficacy of various manual therapy techniques applied on the cervical and / or upper dorsal region, suggesting significant positive changes in cervical pain and mobility levels in patients with nonspecific cervical pain. It is necessary to bear in mind that the reality of the osteopathic approach to the patient is not limited to the use of a single technique, but that the treatment is formed from a set of them. The ultimate goal is to restore mobility and functionality to a specific region, especially taking into account the concepts of individuality and holism.
A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
Read the detailed description
At the beginning of the 1st session, a battery of questions will be made as an anamnesis with the objective of evidencing possible risk factors at the therapeutic level. The presence of one or more risk factors will suppose the exclusion of the patient from the study.
Next, a brief osteopathic musculoskeletal evaluation will be made to the patient. This exploration will follow a standardized protocol for all patients in the experimental groups (1 and 2).
The tests to be carried out will be:
- Observation (standing patient):
- Assessment of the anterior projection of the head
- Assessment of the variation in the physiological curves of the spine
- Active test of the cervical spine with the patient in a sitting position.
- Flexo-Extension / Rotations / Lateral inclinations
- Segmental test of joint mobility of the cervical and dorsal spine (patient in sitting and supine position)
- Passive mobility test of the cervical spine (patient in the supine position):
- Flexo-Extension / Rotations / Lateral inclinations
The combination of exercises scheduled at home for all groups is based on the conclusions of different studies, and will consist of:
- Self-resisted active exercise in flexion, rotations and inclinations of the cervical spine.
- Active mobility in its maximum travel (without forcing pain) in flexion, rotations and inclinations of the cervical spine.
- Stretching upper trapezius muscles and scalenes.
- Active mobility in circumferential joints of the glenohumeral joint, and in flexo-extension of the thoracic spine.
The work schedule will be carried out for 7 weeks, at a rate of 5 sessions per week.
It will be the patient himself who will keep a diary record of the activity carried out during the weeks that the trial lasts. The diary will be facilitated by the therapists, and in it the exercises to be performed will be indicated.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
The OMT (Osteopathic Manipulative Treatment) techniques that may be applied will be the following:
- Technique of Inhibition of the suboccipital muscles
- Functional technique for the middle and deep cervical fascia
- High-speed cervical spine technique (Cervical wheel C1-C6)
- High-speed technique in the cervico-dorsal junction (prone position)
- High speed technique in dorsal column (D1-D12) - (Dog Technique)
- Muscle stretching technique of the diaphragm (supine decubitus)
- Thorax joint mobility technique (long lever)
Main Variable:
- Neck Disability Index (NDI). The investigators establish the minimum change to be detected (minimum clinically relevant change) at 5 points. The Spanish version of the NDI will be used, validated by Andrade Ortega et al.24
Secondary Variable:
- Degree of general quality of life, through the "SF-36" Health Survey25.
The data will be reported in the form of a report by the patient himself, who will receive via e-mail (whenever possible) or in printed form the questionnaire to be completed and will deliver to the same center in which the intervention has been carried out.
- Conditions
- Manual Therapies, Neck Pain
- Being tested
- Osteopathic Manipulative Treatment (OMT) - Temp1, Combined Exercises
- Keywords
- osteopathy, osteopathic treatment, non-specific
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT) - Temp1Other
A total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
Combined ExercisesOther
A home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality
| Study group | Role | What they receive |
|---|---|---|
| Combined exercises+OMT weekly | Experimental | * This group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality
* This group will also receive Osteopathic Manipulative Treatment (OMT): exactly 3 sessions with a weekly frequency (with + -2 days of margin: between 5 and 9 days). Receives: Other: Osteopathic Manipulative Treatment (OMT) - Temp1; Other: Combined Exercises |
| Combined exercises+OMT once every 3 weeks | Experimental | * This group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality
* This group will also receive Osteopathic Manipulative Treatment (OMT): exactly 3 sessions at the rate of one session every 3 weeks (with + -2 days of margin: between 19-23 days). Receives: Other: Osteopathic Manipulative Treatment (OMT) - Temp1; Other: Combined Exercises |
| Combined exercises | Experimental | This group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality. Receives: Other: Combined Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of osteopathic treatment
The effectiveness of osteopathic treatment will be assessed using two health questionnaires ("SF-36" and "NDI") compared to an exercise plan in patients with nonspecific cervical pain.
Measured: 12 weeks
Secondary outcomes (1)
Temporal Frequency
The result of the treatment applied in different temporal frequencies will be compared.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Manual TherapiesStudies 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
- Parallel groups
- Model description
- A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola D'osteopatia De Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar Hernandez Amigo, Principal investigator, Escola Osteopatia de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156308
- Sponsor's protocol ID
- PR407/18
- Status last verified
- Sep 2019
- First submitted
- 16 Sep 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gross A, Langevin P, Burnie SJ, Bedard-Brochu MS, Empey B, Dugas E, Faber-Dobrescu M, Andres C, Graham N, Goldsmith CH, Bronfort G, Hoving JL, LeBlanc F. Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment. Cochrane Database Syst Rev. 2015 Sep 23;2015(9):CD004249. doi: 10.1002/14651858.CD004249.pub4.
PubMed 26397370Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
PubMed 28666405Franke et al. Franke H, Franke J-D, Fryer G. "Osteopathic manipulative treatment for chronic nonspecific neck pain: A systematic review and meta-analysis". International Journal of Osteopathic Medicine. 2015 Dec;18(4):255-67. [doi:10.1186/1471-2474-15-286]
Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
PubMed 28750310MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.
PubMed 19521015Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
PubMed 1834753Akhter S, Khan M, Ali SS, Soomro RR. Role of manual therapy with exercise regime versus exercise regime alone in the management of non-specific chronic neck pain. Pak J Pharm Sci. 2014 Nov;27(6 Suppl):2125-8.
PubMed 25410083Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
PubMed 24609605Sprafka S, Ward RC, Neff D. What characterizes an osteopathic principle? Selected responses to an open question. J Am Osteopath Assoc. 1981 Sep;81(1):29-33. No abstract available.
PubMed 6895077Pickar JG. Efectos neurofisiológicos de la manipulación vertebral. Osteopatía científica. 2011;6(1):2-18
Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
PubMed 27333481Andrade Ortega JA, Delgado Martinez AD, Almecija Ruiz R. Validation of the Spanish version of the Neck Disability Index. Spine (Phila Pa 1976). 2010 Feb 15;35(4):E114-8. doi: 10.1097/BRS.0b013e3181afea5d.
PubMed 20110848Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.
PubMed 7783470Palacios-Cena D, Alonso-Blanco C, Hernandez-Barrera V, Carrasco-Garrido P, Jimenez-Garcia R, Fernandez-de-las-Penas C. Prevalence of neck and low back pain in community-dwelling adults in Spain: an updated population-based national study (2009/10-2011/12). Eur Spine J. 2015 Mar;24(3):482-92. doi: 10.1007/s00586-014-3567-5. Epub 2014 Sep 11.
PubMed 25208501Cote 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 15561381
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT04156308
- Acronym / sponsor ID
- PR407/18
- Conditions
- Manual Therapies, Neck Pain
- Keywords
- osteopathy, osteopathic treatment, non-specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Escola D'osteopatia De BarcelonaUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 7 Nov 2019 (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.
In Spain cervical pain affects practically 20% of the population annually, while globally it is estimated that between 22% and 77% of the population will suffer cervical pain at some point in their life. Prevalence increases with age, and is more common in women than in men (1.6: 1). Although the natural evolution of cervical pain tends to improve, the rates of recurrence and chronicity are high. And therefore it becomes an anatomical region of interest in relation to the assessment of the effectiveness and / or effectiveness of the osteopathic therapeutic approach. Different studies prove the efficacy of various manual therapy techniques applied on the cervical and / or upper dorsal region, suggesting significant positive changes in cervical pain and mobility levels in patients with nonspecific cervical pain. It is necessary to bear in mind that the reality of the osteopathic approach to the patient is not limited to the use of a single technique, but that the treatment is formed from a set of them. The ultimate goal is to restore mobility and functionality to a specific region, especially taking into account the concepts of individuality and holism.
A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
Detailed description
At the beginning of the 1st session, a battery of questions will be made as an anamnesis with the objective of evidencing possible risk factors at the therapeutic level. The presence of one or more risk factors will suppose the exclusion of the patient from the study.
Next, a brief osteopathic musculoskeletal evaluation will be made to the patient. This exploration will follow a standardized protocol for all patients in the experimental groups (1 and 2).
The tests to be carried out will be:
- Observation (standing patient):
- Assessment of the anterior projection of the head
- Assessment of the variation in the physiological curves of the spine
- Active test of the cervical spine with the patient in a sitting position.
- Flexo-Extension / Rotations / Lateral inclinations
- Segmental test of joint mobility of the cervical and dorsal spine (patient in sitting and supine position)
- Passive mobility test of the cervical spine (patient in the supine position):
- Flexo-Extension / Rotations / Lateral inclinations
The combination of exercises scheduled at home for all groups is based on the conclusions of different studies, and will consist of:
- Self-resisted active exercise in flexion, rotations and inclinations of the cervical spine.
- Active mobility in its maximum travel (without forcing pain) in flexion, rotations and inclinations of the cervical spine.
- Stretching upper trapezius muscles and scalenes.
- Active mobility in circumferential joints of the glenohumeral joint, and in flexo-extension of the thoracic spine.
The work schedule will be carried out for 7 weeks, at a rate of 5 sessions per week.
It will be the patient himself who will keep a diary record of the activity carried out during the weeks that the trial lasts. The diary will be facilitated by the therapists, and in it the exercises to be performed will be indicated.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
For groups 1 and 2, a total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
The OMT (Osteopathic Manipulative Treatment) techniques that may be applied will be the following:
- Technique of Inhibition of the suboccipital muscles
- Functional technique for the middle and deep cervical fascia
- High-speed cervical spine technique (Cervical wheel C1-C6)
- High-speed technique in the cervico-dorsal junction (prone position)
- High speed technique in dorsal column (D1-D12) - (Dog Technique)
- Muscle stretching technique of the diaphragm (supine decubitus)
- Thorax joint mobility technique (long lever)
Main Variable:
- Neck Disability Index (NDI). The investigators establish the minimum change to be detected (minimum clinically relevant change) at 5 points. The Spanish version of the NDI will be used, validated by Andrade Ortega et al.24
Secondary Variable:
- Degree of general quality of life, through the "SF-36" Health Survey25.
The data will be reported in the form of a report by the patient himself, who will receive via e-mail (whenever possible) or in printed form the questionnaire to be completed and will deliver to the same center in which the intervention has been carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.
| Arm | Type | Receives |
|---|---|---|
| Combined exercises+OMT weekly | Experimental | Other: Osteopathic Manipulative Treatment (OMT) - Temp1, Other: Combined Exercises* This group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality * This group will also receive Osteopathic Manipulative Treatment (OMT): exactly 3 sessions with a weekly frequency (with + -2 days of margin: between 5 and 9 days). |
| Combined exercises+OMT once every 3 weeks | Experimental | Other: Osteopathic Manipulative Treatment (OMT) - Temp1, Other: Combined Exercises* This group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality * This group will also receive Osteopathic Manipulative Treatment (OMT): exactly 3 sessions at the rate of one session every 3 weeks (with + -2 days of margin: between 19-23 days). |
| Combined exercises | Experimental | Other: Combined ExercisesThis group will conduct a home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The sample will be formed by patients between the ages of 18 and 75 years, who present cervical pain of any intensity and duration, and with a minimum score of 10 points on the Neck Disability Index (NDI)14,15.
Key exclusion criteria (2 listed)
- Patients who present at the time of recruitment other pathologies or elements that may condition cervical pain, such as: acute shoulder tendinopathy, cervical radiculopathy, chronic diseases of general musculoskeletal involvement (Chronic Fatigue Syndrome and / or Fibromyalgia). Similarly, patients suffering from any type of vertiginous syndrome, who have suffered a whiplash in the last year or who are or have been under treatment for cervical pain in the last 3 months will also be excluded.
- The taking of anti-inflammatories by the patient is not taken as a measure of exclusion. If the patient is under pharmacological treatment, it will be recorded and will be taken into account as a co-intervention. However, this treatment will not be modified under any circumstances nor will it be grounds for exclusion from the study.
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 |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT) - Temp1A total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques. | Other | Combined exercises+OMT once every 3 weeks, Combined exercises+OMT weekly |
| Combined ExercisesA home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality | Other | Combined exercises, Combined exercises+OMT once every 3 weeks, Combined exercises+OMT weekly |
Primary outcome
Effectiveness of osteopathic treatment
Time frame: 12 weeks
The effectiveness of osteopathic treatment will be assessed using two health questionnaires ("SF-36" and "NDI") compared to an exercise plan in patients with nonspecific cervical pain.
1 secondary outcome
Temporal Frequency
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Background: PubMed 26397370Gross A, Langevin P, Burnie SJ, Bedard-Brochu MS, Empey B, Dugas E, Faber-Dobrescu M, Andres C, Graham N, Goldsmith CH, Bronfort G, Hoving JL, LeBlanc F. Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment. Cochrane Database Syst Rev. 2015 Sep 23;2015(9):CD004249. doi: 10.1002/14651858.CD004249.pub4.
- Background: PubMed 28666405Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
- BackgroundFranke et al. Franke H, Franke J-D, Fryer G. "Osteopathic manipulative treatment for chronic nonspecific neck pain: A systematic review and meta-analysis". International Journal of Osteopathic Medicine. 2015 Dec;18(4):255-67. [doi:10.1186/1471-2474-15-286]
- Background: PubMed 28750310Fredin K, Loras H. Manual therapy, exercise therapy or combined treatment in the management of adult neck pain - A systematic review and meta-analysis. Musculoskelet Sci Pract. 2017 Oct;31:62-71. doi: 10.1016/j.msksp.2017.07.005. Epub 2017 Jul 21.
- Background: PubMed 19521015MacDermid JC, Walton DM, Avery S, Blanchard A, Etruw E, McAlpine C, Goldsmith CH. Measurement properties of the neck disability index: a systematic review. J Orthop Sports Phys Ther. 2009 May;39(5):400-17. doi: 10.2519/jospt.2009.2930.
- Background: PubMed 1834753Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
- Background: PubMed 25410083Akhter S, Khan M, Ali SS, Soomro RR. Role of manual therapy with exercise regime versus exercise regime alone in the management of non-specific chronic neck pain. Pak J Pharm Sci. 2014 Nov;27(6 Suppl):2125-8.
- Background: PubMed 24609605Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014 Mar 7;348:g1687. doi: 10.1136/bmj.g1687.
- Background: PubMed 6895077Sprafka S, Ward RC, Neff D. What characterizes an osteopathic principle? Selected responses to an open question. J Am Osteopath Assoc. 1981 Sep;81(1):29-33. No abstract available.
- BackgroundPickar JG. Efectos neurofisiológicos de la manipulación vertebral. Osteopatía científica. 2011;6(1):2-18
- Background: PubMed 27333481Gonzalez-Alvarez FJ, Valenza MC, Torres-Sanchez I, Cabrera-Martos I, Rodriguez-Torres J, Castellote-Caballero Y. Effects of diaphragm stretching on posterior chain muscle kinematics and rib cage and abdominal excursion: a randomized controlled trial. Braz J Phys Ther. 2016 Jun 16;20(5):405-411. doi: 10.1590/bjpt-rbf.2014.0169.
- Background: PubMed 20110848Andrade Ortega JA, Delgado Martinez AD, Almecija Ruiz R. Validation of the Spanish version of the Neck Disability Index. Spine (Phila Pa 1976). 2010 Feb 15;35(4):E114-8. doi: 10.1097/BRS.0b013e3181afea5d.
- 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.
Oscar Hernandez Amigo principal investigator
Escola Osteopatia de Barcelona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) - Temp1 and Combined Exercises in people with Manual Therapies and Neck Pain, run by Escola D'osteopatia De Barcelona at 3 sites 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 2 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 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Hernandez Amigo (+(34) 649.360.771, oscarha@eobosteopatia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of osteopathic treatment (time frame: 12 weeks). 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 NCT04156308, which also lists 22 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 7 Nov 2019.