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Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain

Primary Purpose

Cervical Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Diaphragm, Stomach and Liver techniques
Stomach and Liver techniques
Sham technique
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain focused on measuring Chronic Neck Pain, Diaphragm, Manual Therapy, Osteopathy, Visceral Techniques

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Escola Superior da Saúde do Porto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control Group (GC)

Experimental Group A (GEA)

Experimental Group B (GEB)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 13, 2023
Last Updated
June 26, 2023
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT05914129
Brief Title
Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain
Official Title
Efficacy of Osteopathic Visceral Treatment on the Diaphragm, Stomach and Liver in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
July 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain
Keywords
Chronic Neck Pain, Diaphragm, Manual Therapy, Osteopathy, Visceral Techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group (GC)
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experimental Group A (GEA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Experimental Group B (GEB)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diaphragm, Stomach and Liver techniques
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stomach and Liver techniques
Intervention Description
In this group, techniques are the exact same as described previously but only liver and stomach ones will be performed.
Intervention Type
Other
Intervention Name(s)
Sham technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in level of incapacity derived from neck pain 7 days after the intervention
Description
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.
Time Frame
7 days after the intervention
Title
Change in level of pain throughout the 7 days following the intervention
Description
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.
Time Frame
Once a day for the 7 days after the intervention
Secondary Outcome Measure Information:
Title
Change in perception of the global conditions throughout the 7 days following the intervention
Description
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.
Time Frame
Once a day for the 7 days after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natália MO Campelo, PhD
Phone
938674365
Ext
+351
Email
ncampelo.estsp.ipp.pt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natália MO Campelo
Organizational Affiliation
Escola Superior de Saúde do Politécnico do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola Superior da Saúde do Porto
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
35986986
Citation
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Results Reference
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Citation
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Results Reference
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Efficacy of Osteopathic Visceral Treatment in Patients With Chronic Neck Pain

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