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Trial registered on ANZCTR


Registration number
ACTRN12619001137189
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
14/08/2019
Date last updated
10/12/2020
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
"Modifications in patients with subacute or chronic mechanical neck pain after osteopathic treatment and conventional physiotherapeutic treatment"
Scientific title
"Modifications in patients with subacute or chronic mechanical neck pain after osteopathic treatment and conventional physiotherapeutic treatment"
Secondary ID [1] 298368 0
None
Universal Trial Number (UTN)
U1111-1231-4953
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with cervical pain. 313031 0
Patients with cranial-mandibular pain. 313326 0
Pacients diagnosed with subacute or chronic mechanical cervical pain 313655 0
Condition category
Condition code
Musculoskeletal 311541 311541 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311973 311973 0 0
Physiotherapy
Injuries and Accidents 311974 311974 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 311975 311975 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 311976 311976 0 0
Other alternative and complementary medicine
Musculoskeletal 311977 311977 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Trial, randomized-controlled, parallel, double-blind, two-arm trial

The capacity to carry out the study must be measured in the present availability of the means (material and human) necessary to carry it out:
Material resources:
- Hydraulic stretcher without drop
- One caliber to measure the amplitude of the opening of the mouth, scientifically validated.
- One Algometer to measure the pressure pain threshold (PDP), scientifically validated.
- One goniometer to measure the range of cervical mobility, Cervical Range of Motion35 (CROM) validated scientifically.
- Wide and comfortable room with constant temperature.
- For the performance of quality clinical trials, precise tools are required to measure the results that are properly validated. For this, the cervical pain measurement scale and / or associated disability is used: Neck Disability Index (NDI).

Human resources:
- One therapist who performs osteopathic manipulative treatment and / or conventional physiotherapy with more than five years of experience.
- One external evaluator to assess the parameters (Amplitude of the opening of the mouth, pain threshold to pressure" (PTP) and cervical mobility) assessing the interobserver and intraobserver reliability (2 measurements each observer). Perfectly trained and more than 5 years of experience.
- Patients that meet the inclusion criteria determined, in an amount necessary for compliance with the study.
STUDY PROTOCOL:
1- Random assignment of control and experimental groups (Arm-1 and Arm-2) (neither the patient nor the evaluators know the group in which the patient is located, thus achieving double blindness of the study).
The mode of delivery will be face to face it will be provided individually before the interventions.
a- Experimental group: (Arm-1)
- Determine the patient's compliance with the inclusion criteria and that does not meet the exclusion criteria.
- Reading of informative sheet.
- Reading and signing of informed consent.
- Reading and filling out the "Neck Disability Index" (NDI) questionnaire. Measurement scale of cervical pain and / or associated disability, to be able to see the difference of score between the experimental group and the control group in said numerical scale.
- Control of ambient temperature (17-25 ºC).
- The patient lies on the stretcher 10 minutes with both arms at chest level.
- Measurement of the active vertical opening of the mouth before the intervention ..
- Measurement of the "pain threshold to pressure" (PTP) of the triggerspoints that the patient presents in both masseters before the intervention.
- Measurement of the goniometry of the cervical spine:
- Realization of the osteopathic treatment:
OSTEOPATHIC TREATMENT:
1. Global manipulation technique Occipito-alto-axoidea (OAA) according to Fryette Bilateral:
2. DOG TECHNIQUE IN BILATERAL EXTENSION for manipulation of dorsal vertebrae:
3. PELVIS GLOBAL TECHNIQUE:
4. Suboccipital Inhibition Technique
5. Thrust technique on the occipito-mastoid suture
6. Technique Mobilization in Cervical Extension (MEC)
7. Technique for the Mediastinum Previous
8. Inhibition of the Phrenic Center Technique
- New measurement of active vertical opening of the mouth after the intervention after passing 1min.
- New measurement of "pain threshold to pressure" (PTP) in trigger points of masseters after the intervention.
- New measurement of the goniometry of the cervical spine 7
- Do it during 2 sessions, one session per week (every 7 days). 2 session of an hour approximately, once per week during two weeks.
- The invertention will be performs in a private Physiotherapy Clinic.
- At the end of the 2nd session, fill out Neck Disability Index (NDI) again and show if there were changes.
b- Control group: (Arm-2)
- Determine the patient's compliance with the inclusion criteria and that does not meet the exclusion criteria.
- Reading of informative sheet.
- Reading and signing of informed consent.
- Reading and filling out the "Neck Disability Index" (NDI) questionnaire. Measurement scale of cervical pain and / or associated disability, to be able to see the difference of score between the experimental group and the control group in said numerical scale.
- Control of ambient temperature (17-25 ºC).
- The patient lies on the table for 5 minutes with both arms at chest level.
- Measurement of the active vertical opening of the mouth before the intervention.
- Measurement of "pain threshold to pressure" (PTP) in trigger points of masseters before the intervention.
- Measurement of cervical goniometry
- Performing the conventional physiotherapy treatment:
- New measurement of active vertical opening of the mouth after the intervention after passing 1min.
- New measurement of "pain threshold to pressure" (PTP) in trigger points of masseters after the intervention.
- New measurement of cervical goniometry.
- Do it during 2 sessions, one session per week (every 7 days). 2 session of half an hour approximately, once per week during two weeks.
- The invertention will be performs in a private Physiotherapy Clinic.
- At the end of the 2nd session, fill out Neck Disability Index (NDI) again and show if there were changes.
2- Data registration and statistical analysis
Intervention code [1] 314614 0
Rehabilitation
Intervention code [2] 314990 0
Treatment: Other
Comparator / control treatment
Conventional physiotherapy treatment:
1. Application of the tetrapolar TENS device with the "I-tech Mio-care" device in the analgesia program with an intensity of between 10-20 milliamps, according to the tolerance of the patient with an application time of 15 minutes. Was the TENS applied at a frequency of 80 Hz, phase duration = 150 µs and adjusted amplitude? In zone of origin and insertion of upper trapezoids. (p <0.01)
2. Infrared lamp of 250w at a distance of 1m from the patient, with an application time of 10 minutes.
3. Ultrasound: applied on the suboccipital muscle area with a frequency of 1Mhz, at an intensity of 1.2w / cm2 and with an application time of 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 320244 0
Mouth opening assessed using a caliber scientifically validated,
Timepoint [1] 320244 0
7 days (primary timepoint) and 15 days after intervention commencement
Primary outcome [2] 320704 0
Composite primary outcome: masseter and temporal triggerspoint pain thershold assessed using a scientifically validated algometer.
Timepoint [2] 320704 0
7 days (primary timepoint) and 15 days after intervention commencement
Primary outcome [3] 320746 0
cervical mobility assessed using a scientifically validated goniometer
Timepoint [3] 320746 0
7 days (primary timepoint) and 15 days after intervetion commencement
Secondary outcome [1] 370971 0
Cervical pain as assessed by Neck Disability Index
Timepoint [1] 370971 0
15 days post commencement of intervention

Eligibility
Key inclusion criteria
Patients with symptoms of cervical pain, diagnosed with subacute or chronic mechanical neck pain. Chronic mechanical neck pain (CMC)
-Patients with limitation in the opening of the mouth of less than 40mm, without the need to suffer symptoms in the ATM
-Whole age (between 18 and 50 years old)
-With signed written consent.
-No difference of sex.
-Patients dysfunction or disorders in the high cervical
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Any surgical intervention in upper limbs, head or spine at any time of their lives.
- Having received previous osteopathic treatment in the last two months.
- Having received medical treatment two weeks before the study.
- Refusal of the patient to participate in the study.
- Any Contraindication to the application of the treatment or evaluations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2020
Actual
4/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 21535 0
Spain
State/province [1] 21535 0
Chiclana de la Frontera (Cádiz)

Funding & Sponsors
Funding source category [1] 302906 0
Other Collaborative groups
Name [1] 302906 0
"Fisioclinic" Physioteraphy private Clinic
Country [1] 302906 0
Spain
Primary sponsor type
Other Collaborative groups
Name
"Fisioclinic" Physioteraphy private Clinic
Address
Nuestra Señora de los Remedios Street, Number 12
Chiclana de la Frontera
Cádiz
11130
Country
Spain
Secondary sponsor category [1] 302865 0
None
Name [1] 302865 0
Address [1] 302865 0
Country [1] 302865 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303478 0
CEI Cádiz (Comité de Ética Internacional)
Ethics committee address [1] 303478 0
CEI de Cádiz
Despacho 817. 8ª Planta
Hospital Universitario Puerta del Mar
Tfno: 956002005
Ethics committee country [1] 303478 0
Spain
Date submitted for ethics approval [1] 303478 0
09/04/2019
Approval date [1] 303478 0
26/09/2019
Ethics approval number [1] 303478 0

Summary
Brief summary
1. To evaluate the changes that occur in the experimental group after the application of osteopathic treatment in the variables.
2. To evaluate the changes that occur in the control group after the application of the conventional physiotherapy treatment, in the variables
Hypothesis:
The applied osteopathic treatment causes greater results in patients with subacute or chronic cervical pain after 2 sessions of treatment. than the conventional physiotherapy treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93790 0
Mr Francisco José Vera Serrano
Address 93790 0
Calle Zeus Número 20
Chiclana de la Frontera
Cádiz
11130
"Fisioclinic" Physioteraphy Private Clinic
Country 93790 0
Spain
Phone 93790 0
+34669604982
Fax 93790 0
Email 93790 0
[email protected]
Contact person for public queries
Name 93791 0
Francisco José Vera Serrano
Address 93791 0
Calle Zeus Number 20
Chiclana de la Frontera
Cádiz
11130
"Fisioclinic" Physioteraphy Private Clinic
Country 93791 0
Spain
Phone 93791 0
+34669604982
Fax 93791 0
Email 93791 0
[email protected]
Contact person for scientific queries
Name 93792 0
Francisco José Vera Serrano
Address 93792 0
Calle Zeus Number 20
Chiclana de la Frontera
Cádiz
11130
"Fisioclinic" Physioteraphy Private Clinic
Country 93792 0
Spain
Phone 93792 0
+34669604982
Fax 93792 0
Email 93792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2222Informed consent form    377683-(Uploaded-30-05-2019-05-57-09)-Study-related document.docx



Results publications and other study-related documents

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