Protocol summary

Summary
(1) Objective: The aim of this study was to determine and compare effectiveness of cervical stabilization exercises and proprioceptive neuromuscular facilitation exercises on crossed sectional area of deep flexor muscles in non-specific Chronic Neck Pain patients. (2) Design: This study is a kind of experimental study, clinical trial and it is done on forty four non-specific chronic neck pain patients. (3) Setting and conduct: Patients randomly assigned to two groups of stabilization exercises and proprioceptive neuromuscular facilitation. Pain, intensity of disability and cross sectional area of deep flexors of neck are measured with VAS, NDI questionnaires and ultrasonography respectively before and after intervention. Expected time for treatment of both groups is eight weeks.(4) Participants: Participants are from chronic neck pain patients that referred to clinics, later inclusion and exclusion criteria will be applied to them. (5) Intervention: In this study, interventions are stability and proprioceptive neuromuscular facilitation exercises of neck. (6) Variables: Pain, cross sectional area of muscles and neck disability index will be measured before and after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016060128203N1
Registration date: 2016-07-12, 1395/04/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-12, 1395/04/22
Registrant information
Name
Parisa Ghadiri Harati
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 2057
Email address
a_karimi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-07-26, 1395/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of proprioceptive neuromuscular facilitation and stabilization exercises on cross sectional area of deep flexor muscles in chronic non-specific neck pain
Public title
Effectiveness of proprioceptive neuromuscular facilitation and stabilization exercises on cross sectional area of deep flexor muscles in chronic non-specific neck pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Men and women; Aged 20 to 50 years; With chronic non-specific neck pain; With BMI between 25 to 30. Exclusion criteria: Protrusion or Prolapse of disc with neurologic symptoms; Spinal surgery; Existence of certain structural damage in the neck; Neck pain caused by autoimmune diseases; Inflammation; Congenital deformity of spine; Compression fracture because of Osteoporosis; Stenosis and Spondylolysis or Spondylolisthesis; Myofacial Trigger Point; Shoulder injury; Rheumatoid arthritis; Pregnancy; Torticollis; Diabetes; Lung diseases; Myopathies; Cancer; History of physical therapy intervention on neck or shoulder in last three months; Physiotherapy; Chiropractic treatment; Osteopathy; Massage and so on to the neck or shoulders in the last three months.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan Medical School, Khalij Fars Boulevard, Zahedan, IRAN
City
Zahedan
Postal code
9816743175
Approval date
2015-10-23, 1394/08/01
Ethics committee reference number
IR.zaums.rec.1394.271

Health conditions studied

1

Description of health condition studied
Chronic neck pain
ICD-10 code
M79.9
ICD-10 code description
Soft tissue disorder, unspecified

Primary outcomes

1

Description
Cross-sectional area of deep neck flexor
Timepoint
Before intervention and 2 months after intervention
Method of measurement
By ultrasonography and per square centimeter

Secondary outcomes

1

Description
Neck Disability Index
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Neck Disability Index questionnaire

2

Description
Pain
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Visual Analog Scale questionnaire

Intervention groups

1

Description
Stability group: Patient will train stability exercises of neck and shoulder for 8 weeks.
Category
Rehabilitation

2

Description
PNF group: In this group, patients will train proprioceptive neuromuscular facilitation exercises of neck and upper limbs daily for 8 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research of Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdoost
Street address
Zahedan Medical School, Khalij Fars Boulevard, Zahedan, IRAN
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research of Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parisa Ghadiri Harati
Position
Master of Science
Other areas of specialty/work
Street address
Zahedan Medical School, Khalij Fars Boulevard, Zahedan, IRAN
City
Zahedan
Postal code
Phone
+98 44900826
Fax
Email
ghadiri.pt93@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parisa Ghadiri Harati
Position
Master of Science
Other areas of specialty/work
Street address
Zahedan Medical School, Khalij Fars Boulevard, Zahedan, IRAN
City
Zahedan
Postal code
۹۸۱۶۷۴۳۱۷۵
Phone
+98 21 4490 0826
Fax
Email
ghadiri.pt93@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Parisa Ghadiri Harati
Position
Master of Science
Other areas of specialty/work
Street address
Zahedan Medical School, Khalij Fars Boulevard, Zahedan, IRAN
City
Zahedan
Postal code
۹۸۱۶۷۴۳۱۷۵
Phone
+98 21 4490 0826
Fax
Email
ghadiri.pt93@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...