Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156308
Recruitment Status : Not yet recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Escola D'osteopatia De Barcelona

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Manual Therapies Neck Pain Other: Osteopathic Manipulative Treatment (OMT) - Temp1 Other: Combined Exercises Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description:

A double masking is proposed. Three active interventions are compared. The patients will be blinded in relation to the study group they belong to, ensuring the masking of the participants.

The data that is intended to be obtained for its analysis are of a self-reported nature and will be collected and administered by an external investigator not linked to the interventions, ensuring the masking of the evaluator.

Due to the nature of the interventions, masking of therapists is not possible.

Primary Purpose: Treatment
Official Title: Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain: Randomized Controlled Pragmatic Clinical Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combined exercises+OMT weekly
  • 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).
Other: Osteopathic Manipulative Treatment (OMT) - Temp1
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.

Other: Combined Exercises
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

Experimental: Combined exercises+OMT once every 3 weeks
  • 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).
Other: Osteopathic Manipulative Treatment (OMT) - Temp1
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.

Other: Combined Exercises
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

Experimental: 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.
Other: Combined Exercises
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Temporal Frequency [ Time Frame: 12 weeks ]
    The result of the treatment applied in different temporal frequencies will be compared.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156308


Contacts
Layout table for location contacts
Contact: Oscar Hernandez Amigo +(34) 649.360.771 oscarha@eobosteopatia.com

Locations
Layout table for location information
Spain
IntegroSalus
Cabrils, Barcelona, Spain, 08348
Contact: Oscar Hernandez Amigo    +34.649.360.771    oscarha@eobosteopatia.com   
Principal Investigator: OSCAR HERNANDEZ AMIGO         
AXIS
Sant Sadurní d'Anoia, Barcelona, Spain, 08770
Contact: DAVID PUERTAS    +34.606.450.462    dpuertas81@gmail.com   
Principal Investigator: DAVID PUERTAS         
Clinica Osteopatia Horta
Barcelona, Spain, 08031
Contact: EDGAR SEGARRA CALLIZO    +34.657.559.428    edbandini@gmail.com   
Principal Investigator: EDGAR SEGARRA CALLIZO         
Sponsors and Collaborators
Escola D'osteopatia De Barcelona
Investigators
Layout table for investigator information
Principal Investigator: Oscar Hernandez Amigo Escola Osteopatia de Barcelona
  Study Documents (Full-Text)

Documents provided by Escola D'osteopatia De Barcelona:
Informed Consent Form  [PDF] November 20, 2018
Study Protocol  [PDF] November 5, 2019

Publications of Results:

Other Publications:
Franke 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]
Pickar JG. Efectos neurofisiológicos de la manipulación vertebral. Osteopatía científica. 2011;6(1):2-18

Layout table for additonal information
Responsible Party: Escola D'osteopatia De Barcelona
ClinicalTrials.gov Identifier: NCT04156308    
Other Study ID Numbers: PR407/18
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Escola D'osteopatia De Barcelona:
osteopathy, osteopathic treatment, non-specific
Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms