Effectiveness of the Osteopathic Treatment in Patients With Nonspecific Cervical Pain

NCT04156308 | Unknown

• 1 other identifier: PR407/18
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 3

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.

Conditions

Manual Therapies; Neck Pain

Keywords

osteopathy, osteopathic treatment, non-specific

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Temporal Frequency

  12 weeks

Study Arms (3)

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).

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).

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.

Other: Combined Exercises

Interventions

Osteopathic Manipulative Treatment (OMT) - Temp1 OTHER

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 exercises+OMT once every 3 weeks; Combined exercises+OMT weekly

Combined Exercises OTHER

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

Combined exercises; Combined exercises+OMT once every 3 weeks; Combined exercises+OMT weekly

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola D'osteopatia De Barcelona: lead

Study Sites (3)

IntegroSalus

Cabrils, Barcelona, 08348, Spain

Location

AXIS

Sant Sadurní d'Anoia, Barcelona, 08770, Spain

Location

Clinica Osteopatia Horta

Barcelona, 08031, Spain

Location

Related Publications (22)

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MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Oscar Hernandez Amigo

  Escola Osteopatia de Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oscar Hernandez Amigo

CONTACT

+(34) 649.360.771; oscarha@eobosteopatia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pragmatic experimental comparative trial with three branches of study (osteopathic treatment with 2 different dosages versus active muscle exercise) is proposed.

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: November 7, 2019
• Study Start: December 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 7, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)