Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain

Study Overview
=================
Brief Summary
-----------------
This study aims to analyze the effects of visceral osteopathic treatment of the diaphragm, stomach and liver in the treatment of chronic neck pain.

Detailed Description
-----------------
Cervical pain is a very common condition, whom can originate from bad posture, cervical tension, anxiety, depression and occupational or sportive activities. The influence of mobility and function changes of the abdominal viscera in the cervical region is a mechanism that is still poorly described in literature. It is expected to find, through mechanical and neural pathways, that the visceral osteopathy treatment will have some effect on chronic neck pain. This study intends to check the effects of the diaphragm stretching, inferior mobilization of the stomach and liver pump techniques (restoring mobility and normalizing function of the viscera) on the neck region, by employing some questionnaires/instruments. During the present study, the effects of the visceral techniques will be analyzed in the following variables: Neck Disability Index (NDI), Numeric Pain Scale (NPS or END) and Global Pain Scale (GPS or EPGM).

Official Title
-----------------
Efficacy of Osteopathic Visceral Treatment on the Diaphragm, Stomach and Liver in Patients With Chronic Neck Pain

Conditions
-----------------
Cervical Pain

Intervention / Treatment
-----------------
* Other: Diaphragm, Stomach and Liver techniques
* Other: Stomach and Liver techniques
* Other: Sham technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain in the posterior cervical region for more than 3 months; Knowing how to read and write; Exclusion Criteria: Recent Cervicothoracic or Thoracoabdominal trauma (less than 6 months); Surgical procedure in the cervical region less than 6 months ago Surgical procedure in the abdominal region less than 6 months ago; Diagnosis of disc disease/radiculopathy; Rheumatic and/or neurological disease; Pregnancy status

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control Group (GC)<br>To each volunteer, after 2 questionnaires, sham techniques will be performed to this group. The investigator will mimic the technique contacts without actually performing any type of tissue traction or compression, maintaining contact for the same amount of time described in the refered techniques. Following the technique, volunteers will answer the same 2 questionnaires shown previously. | Other: Sham technique<br>* In the sham group, manual contact without any therapeutic intention will be performed in the same regions as the experimental groups. This contact will be maintained during the same amount of time as for the experimental group A.<br>|
| Experimental: Experimental Group A (GEA)<br>To each volunteer, after 2 questionnaires, Diaphragm Stretching, Lower stomach mobilization and Liver pump techniques will be performed to this group. The diaphragm technique is performed 2 times with 1 minute interval, with the duration of 10 respiratory cycles. The lower stomach mobilization and liver pump techniques are performed one time, for 5 minutes each. Following the technique, volunteers will answer the same 2 questionnaires shown previously. | Other: Diaphragm, Stomach and Liver techniques<br>* Diaphragm Stretching: The participant is seating down and the researcher will be behind, placing their hands on the inferior costal border. Cephalic traction is performed during inhalation, remaining during exhalation. Procedure is repeated 2 times, for 10 respiratory cycles, with 1-minute intervals. Inferior Mobilization of the Stomach: The participant is seating down with slight flexion of the torso, while the investigator stands behind them, placing the thumbs on the epigastric region. The volunteer will extend their body while the researcher performs a caudal traction. This procedure lasts 5 minutes. Liver Pump: Participant is laying on their back, and the investigator is standing on the participants side. The researcher places one hand on the right side inferior costal border posteriorly and the other one bellow the costal border anteriorly. Researcher compresses during exhalation and releases their hands abruptly during inhalation. This procedure lasts 5 minutes.<br>|
| Experimental: Experimental Group B (GEB)<br>To each volunteer, after 2 questionnaires, Lower stomach mobilization and Liver pump techniques will be performed to this group. These 2 techniques are the same ones as described for the experimental group A. Following the technique, volunteers will answer the same 2 questionnaires shown previously. | Other: Stomach and Liver techniques<br>* In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of incapacity derived from neck pain 7 days after the intervention | The Neck Disability Index questionnaire (NDI) will be the instrument used to evaluate the level of incapacity caused by neck pain. The questionnaire has 10 questions about the volunteers everyday life activities. There are 6 options to each question and the participant must choose the one that applies the most to their experience. The options selected will account for a score that goes from 0 to 50. The higher the number of the option, the more incapacity is felt and reported by the participant, meaning a worse outcome. This data will be collected by asking the volunteer their preferred option and writing it down. | 7 days after the intervention | 
| Change in level of pain throughout the 7 days following the intervention | The pain outcome will be measured according to the volunteers perception of pain in the cervical region by using the Numerical Pain Scale (NPS). This scale ranges from 0 to 10 and the participant must choose one number that best suits their level of current pain, 0 corresponding to no pain and 10 being the worst pain imaginable to that participant. The higher the number, the worse the outcome. This data will be collected by asking the volunteer for the corresponding number and writing it down. | Once a day for the 7 days after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perception of the global conditions throughout the 7 days following the intervention | One week after the intervention, the participants must answer the Global Perception of Change Scale (GPCS), which presents 7 options (from 1 to 7). The higher the number of the option, the more change was perceived and reported by the participant, meaning a better outcome. This instrument will guide the researcher to better understand if the intervention resulted in any kind of change to their initial condition. This data will be collected by asking the volunteer their preferred option and writing it down. | Once a day for the 7 days after the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Neck Pain, Diaphragm, Manual Therapy, Osteopathy, Visceral Techniques