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Comparison of Treatment methods based on Strength-Endurance exercise with and with out Thoracic Manipulation to Improve the body Balance , Pain and Disability of patients with Non Specific chronic Neck pain

Protocol summary

Study aim
Comparison of Treatment methods based on Strength-Endurance exercise with and with out thoracic Manipulation to improve the body balance , pain and disability of patient with non specific chronic Neck pain
Design
Block Randomized Allocation with control group, parallel group Trial with Double blinded outcome assessment, with 40 participants
Settings and conduct
School of Rehabilitation Shiraz University sciences. All the patients are blinded and assessments in this study are done by trained physiotherapist who is unaware from patient classifications in two group. Intervention group will revive another intervention in addition of control group.
Participants/Inclusion and exclusion criteria
inclusion criteria: 18 - 60 yeaes old patient with the history of neck pain for more than 3 months, scoring 15_24 on neck disability index that shows moderate pain, scoring 31-69 millimeters on visual analouge scale, exclusion criteria: nerve injury or spinal cord compression, surgery, instability and whiplash injury, cancer, balance disturbance and dizziness,
Intervention groups
At the beginning, patients with non specific chronic neck pain fill out the personal information questionaries, then their pain , disability and balance will be measured. after that in intervention and control group will be done strength-Endurance exercise for six weeks then we ask both group to do the exercise two times a day. these exercise include the progressive strength-Endurance training while the patient supine and prone lying with head support then bring up his head until the neck is bending. in intervention group manipulation must be done in 3 sessions every 4 days in supine position.after six weeks of doing these exercises patients pain, neck disability and balance will be measured again.
Main outcome variables
Changes in Balance, Pain and Neck Disability Index after intervention

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181020041395N1
Registration date: 2018-12-21, 1397/09/30
Registration timing: registered_while_recruiting

Last update: 2018-12-21, 1397/09/30
Update count: 0
Registration date
2018-12-21, 1397/09/30
Registrant information
Name
Amir Eskandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3233 4982
Email address
eskandari_a@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-11, 1397/08/20
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Treatment methods based on Strength-Endurance exercise with and with out Thoracic Manipulation to Improve the body Balance , Pain and Disability of patients with Non Specific chronic Neck pain
Public title
Checking the effect of exercise in balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
the history of neck pain for more than 3 months Scoring 15 - 24 on Neck Disability Index Scoring 31- 69millimeters on Visual Analoge Scale 18- 60 years old patient
Exclusion criteria:
Nerve injury or spinal cord compression Surgery , Instability , truma and Whiplash injury Cancer Sever osteoporosis history of Traumatic Brain Injury Increase pain as much as the patient would not cooperate with treatment Balance disturbance and dizziness
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block Random Allocation In this case different situation that patient classify in 2 group will be written. then these six situation (ABAB, BABA , AABB, BBAA ,ABBA, BAAB) will be put in six sealed enveloped and patient will be divided by random withdrawal to put in 2 groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
All the patients are blinded and the assessments in this study are done by trained physiotherapist who is unaware from patients classifications in two group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central bulding of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.SUMS.REC.1397.512

Health conditions studied

1

Description of health condition studied
Non specific chronic Neck pain
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
Balance based on Balance Error Scoring System
Timepoint
Beginning of research and seven Weeks after started intervention
Method of measurement
Balance Error Scoring System

Secondary outcomes

1

Description
Pain based on Visual Analogue Scale
Timepoint
Beginning of research and seven weeks after started intervention
Method of measurement
Visual Analogue Scale

Intervention groups

1

Description
Intervention Group: At the beginning, patients with non specific chronic neck pain fill out the personal information questionaries, then their pain , disability and balance will be measured. after that in intervention and control group will be done strength-Endurance exercise for six weeks then we ask Intervention group to do the exercise two times a day not more than 20 minutes.these exercise include the progressive strength-Endurance training while the patient supine and prone lying with head support then bring up his head until the neck is bending. in intervention group manipulation must be done in 3 sessions every 4 days in supine position.after six weeks of doing these exercises patients pain, neck disability and balance will be measured again.
Category
Rehabilitation

2

Description
Control group: At the beginning, patients with non specific chronic neck pain fill out the personal information questionaries, then their pain , disability and balance will be measured. after that in control group will be done strength-Endurance exercise for six weeks then we ask control group to do the exercise two times a day not more than 20 minutes.these exercise include the progressive strength-Endurance training while the patient supine and prone lying with head support then bring up his head until the neck is bending. after six weeks of doing these exercises patients pain, neck disability and balance will be measured again.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz School of Rehabilition Sciences
Full name of responsible person
Amir Eskandari
Street address
Shiraz School of Rehabilition Sciences , Abiverdi 1 St., Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1551
Email
Eskandari_a@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice Chancellor of Research, Central bulding of Shiraz University of Medical Sciences , Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Shiraz University of Medical Sciences
Full name of responsible person
Amir Eskandari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 11 , 2 Ave., Shooride St.
City
Shiraz
Province
Fars
Postal code
71736-48445
Phone
+98 71 3233 9225
Email
Eskandari_a@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohre Taghizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shiraz School of Rehabilitation Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1733
Phone
+98 71 3627 1551
Email
Eskandari_a@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Eskandari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No 11., 2 Ave., Shoorideh St.
City
Shiraz
Province
Fars
Postal code
71736-48445
Phone
+98 71 3233 9225
Email
eskandari_a@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information is Available.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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