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Comparison of the effect of combining diaphragmatic exercises and physiotherapy treatment with physiotherapy treatment alone in patients with chronic neck pain

Protocol summary

Study aim
The aim of this study was to compare the effect of combining diaphragmatic exercises and physiotherapy treatment with physiotherapy treatment alone on pain, disability, neck range of motion, chest movement during maximal inhalation and exhalation, forward head posture and upper thoracic angles in patients with chronic neck pain.
Design
A clinical trial with a control group, with parallel, double-blind, randomized groups, conducted a study on 30 patients, the site http://www.graphpad.com/ quickcalcs / index.cfm is used for randomization.
Settings and conduct
The study will be performed using the selection of patients referred to the clinic, based on admission criteria. Patients will be blinded by not knowing the type of treatment in the other group and the evaluator will be blinded by not knowing the grouping of patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women between the ages of 20 and 35 who have chronic neck pain without headache for at least three months, with forward head posture (CVA angle less than 49 degrees), paradoxical breathing, rated 3 or higher on visual analogue scales. Non-inclusion criteria: Cancellation by the patient for any reason, discomfort and intolerance of treatment by the patient, history of heart disease and heart surgery and pregnancy.
Intervention groups
Intervention group: They receive the usual treatment with diaphragmatic exercises, preferably 5 days a week for 10 sessions. Control group: They receive only the usual treatment.
Main outcome variables
Examination of these variables in the first session including age, height, weight, BMI and duration of disease Examining the following variables in the first, tenth and two weeks later sessions, including: Pain intensity Disability Active and passive neck range of motion Chest movement during maximal inhalation and exhalation Forward head posture and upper thoracic angles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210223050476N1
Registration date: 2021-03-28, 1400/01/08
Registration timing: registered_while_recruiting

Last update: 2021-03-28, 1400/01/08
Update count: 0
Registration date
2021-03-28, 1400/01/08
Registrant information
Name
Sima mosallaiezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
s-mosallaiezadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of combining diaphragmatic exercises and physiotherapy treatment with physiotherapy treatment alone in patients with chronic neck pain
Public title
The effect of diaphragmatic exercises and physiotherapy on chronic neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with chronic neck pain without headache who have pain and discomfort in the back of the neck for at least three months Have forward head posture (CVA angle less than 49 degrees) Breathe paradoxically. Have a rating of 3 or higher in the visual analogue scales Have not undergone physiotherapy in the past three months to treat neck pain Be 20 to 35 years old. Have expressed their informed consent to participate in the research project.
Exclusion criteria:
Discontinuation of cooperation by the patient for any reason Feeling uncomfortable and intolerant of treatment by the patient History of heart disease and heart surgery Spine and chest surgeries History of smoking Traumatic neck injuries BMI > 40 Diabetes Acute neuromuscular pain and cervical disc prolapse with neurological symptoms Congenital malformations Cancer or tumor in the last 5 years Patients with sensory impairment Pregnancy
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The second therapist obtains a random sequence through http://www.graphpad.com/ quickcalcs / index.cfm which contains the number with the name of one of the groups (group A or B). Then each person with their eyes closed takes a number from the basket containing numbers from 1 to 30 to be placed in the group specified by the site. To maintain confidentiality, the type of group will not be known before assigning the person in each group. To make the type of treatment random in groups A and B, the second therapist rewrites the type of treatment on two separate cards and puts it in opaque sealed envelopes with a random sequence and then removes one of the envelopes with his eyes closed. The envelope that we will get first will be the type of group A treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded to the type of intervention and the people in each group will not know about the other group. Variables are evaluated by the outcome assessor who is not aware of the grouping.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research School of Nursing and Midwifery and School of Rehabilitation - Tehran U
Street address
Block A, 13th floor, Iran TV St, Between South Flamek and Zarafshan, Ghods Town (West), Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.TUMS.FNM.REC.1399.114

Health conditions studied

1

Description of health condition studied
Study condition: Women with chronic neck pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
The first, tenth and two weeks later
Method of measurement
Visual Analogue Scales

2

Description
Disability
Timepoint
The first, tenth and two weeks later
Method of measurement
Neck Disability Index

3

Description
Active and passive neck range of motion
Timepoint
The first, tenth and two weeks later
Method of measurement
Goniometer

4

Description
Chest movement during maximal inhalation and exhalation
Timepoint
The first, tenth and two weeks later
Method of measurement
Tape meter

5

Description
Forward Head Posture
Timepoint
The first, tenth and two weeks later
Method of measurement
Samsung Galaxy Tab A SM-T355 camera

6

Description
Upper Thoracic Angle
Timepoint
The first, tenth and two weeks later
Method of measurement
Samsung Galaxy Tab A SM-T355 camera

7

Description
Age
Timepoint
Before starting the intervention
Method of measurement
ID card or national card

8

Description
Height
Timepoint
Before starting the intervention
Method of measurement
Tape meter

9

Description
Weight
Timepoint
Before starting the intervention
Method of measurement
Digital bathroom scale

10

Description
Body Mass Index
Timepoint
Before starting the intervention
Method of measurement
Ratio of weight to height squared

11

Description
Duration of chronic neck pain
Timepoint
Before starting the intervention
Method of measurement
Question from the person

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: includes a combination of diaphragmatic exercises and physiotherapy treatment (TENS, IR and Exercise). Diaphragmatic exercises: In the first session, the subjects of the experimental group will be trained in diaphragmatic breathing. In the supine position, the trunk is in a position of 30-50 degrees of flexion and the knees are in a comfortable position of flexion. The person is asked to place their hands on the abdomen and breathe slowly and deeply using the nose for 10 seconds. The subjects held the diaphragmatic exercise while holding the 2.5 kg weight in the first 5 sessions and the 5 kg weight on the abdomen in the second 5 sessions, in three sets with ten repetitions in the ratio of one second to two seconds of exhalation, three The next set consists of 15 repetitions with a two-second to four-second exhalation ratio, and the final three sets consist of 20 repetitions with a three-second to six-second exhalation ratio. A period of 60 seconds is rested between sets. These exercises are done 5 days a week in 10 sessions. Electrical stimulation of TENS: TENS is made by Novin Multistimulator735X made in Iran for 30 minutes (four electrodes on painful areas around the patient's neck with a frequency of 80 Hz, square pulse, duration of each pulse is less than 150 microseconds and the intensity is increased to the point of contraction. Not seen) is used. Infrared rays (IR): The IR of the Tavanbakhsh Novin made in Iran is placed on the neck and back for 20 minutes. Exercise: The Sternocleidomastoid and Upper Trapezious muscles stretching exercises are performed on both sides for 30 seconds with two to three repetitions in each session while sitting on a chair with the soles of the feet on the floor. Chin tuck head lift exercise with Hold and Rest for 10 and 15 seconds, respectively, in the first 5 sessions of each person on the bed with the angle of the head of the bed with the horizon line 60 degrees, and in each session, after each ten-second hold, we reduce the inclination of the head of the bed by ten degrees to apply a load, so that at the end this angle reaches a slope of 30 degrees, and in the second 5 sessions, to apply more load, each person on the bed has an angle. The head of the bed is placed with a horizon line of 30 degrees. And again in each session after each hold for ten seconds, we reduce the inclination of the head of the bed ten degrees until the end of the head of the bed is completely flat (the angle of the head of the bed with the horizon line reaches zero degrees) and each session of this exercise It is repeated ten times in all 4 types of head angle. The duration of each session is 60 to 70 minutes.
Category
Rehabilitation

2

Description
Control group: In the control group, only physiotherapy treatment (TENS, IR and Exercise) similar to the experimental group is used. The duration of each session is 60 to 70 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohsen Mir
Street address
Pich Shemiran, Enghelab St., District 12, Tehran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
ptsimaa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Mohsen Mir
Street address
Pich Shemiran, Enghelab St., District 12, Tehran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
ptsimaa@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima Mosallaiezadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pich Shemiran, Enghelab St., District 12, Tehran
City
Tehran
Province
Tehran
Postal code
111489-65111
Phone
+98 21 7753 3939
Email
smosallaie1072@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima Mosallaiezadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pich Shemiran, Enghelab St., District 12, Tehran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
smosallaie1072@gmil.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sima Mosallaiezadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Pich Shemiran, Enghelab St., District 12, Tehran
City
Tehran
Province
Tehran
Postal code
11489-65111
Phone
+98 21 7753 3939
Email
smosallaie1072@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Treatment is done in ten sessions and evaluation of variables in the first, tenth and two weeks later.
When the data will become available and for how long
Start of access period: 8 months after printing the results
To whom data/document is available
I and my advisor professors
Under which criteria data/document could be used
Under the supervision of me and my advisor professors
From where data/document is obtainable
Come to me. Email address: ptsimaa@gmail.com
What processes are involved for a request to access data/document
Start of access period: 8 months after printing the results
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