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Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain

Primary Purpose

Neck Pain Musculoskeletal

Status
Unknown status
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
"Exercise" and "connective tissue massage"
"Exercise"
Sponsored by
Seyda TOPRAK CELENAY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain Musculoskeletal focused on measuring Neck pain, stabilization exercise, connective tissue massage

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 to 65 years of age,
  • having neck pain for more than 3 months, and
  • being volunteer

Exclusion Criteria:

  • Stenosis,
  • traumatic injury history,
  • previous surgery related to cervical spine,
  • hypermobility,
  • cancer,
  • having inflammatory rheumatologic,
  • severe psychological disorders,
  • being pregnant, and
  • intervention including exercise or physical therapy in the last 3 months

Sites / Locations

  • Ataturk Trainning and Research HospitalRecruiting
  • Ataturk Trainning and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise and connective tissue massage

Exercise

Arm Description

Stabilization exercise and connective tissue massage have been applied

Only stabilization exercise has been applied

Outcomes

Primary Outcome Measures

Change in Neck pain intensity as measured by Visual Analog Scale

Secondary Outcome Measures

Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Change in quality of life as assessed by Short Form-36
Change in pressure pain threshold as measured by digital algometer

Full Information

First Posted
April 8, 2015
Last Updated
April 18, 2015
Sponsor
Seyda TOPRAK CELENAY
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1. Study Identification

Unique Protocol Identification Number
NCT02424032
Brief Title
Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seyda TOPRAK CELENAY

4. Oversight

5. Study Description

Brief Summary
The aim of this study was to investigate and compared the effects of cervical and scapulothoracic stabilization exercises with and without connective tissue massage (CTM) for patients with chronic mechanical neck pain.
Detailed Description
Sixty patients with chronic mechanical neck pain were recruited and randomly allocated into stabilization exercise with and without the connective tissue massage program. The study's inclusion criteria were as follows: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer. The exclusion criteria were as follows: stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months.The program was carried out for 12 sessions, 3 days/week in 4 weeks. Pain intensity with Visual Analog Scale, pressure pain threshold with digital algometer, the level of anxiety with the Spielberger State Trait Anxiety Inventory, and life quality with Short Form-36 were evaluated before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain Musculoskeletal
Keywords
Neck pain, stabilization exercise, connective tissue massage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and connective tissue massage
Arm Type
Experimental
Arm Description
Stabilization exercise and connective tissue massage have been applied
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
Only stabilization exercise has been applied
Intervention Type
Behavioral
Intervention Name(s)
"Exercise" and "connective tissue massage"
Intervention Description
Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
"Exercise"
Intervention Description
Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.
Primary Outcome Measure Information:
Title
Change in Neck pain intensity as measured by Visual Analog Scale
Time Frame
Change from baseline neck pain intensity at 4 weeks
Secondary Outcome Measure Information:
Title
Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Time Frame
Change from baseline level of anxiety at 4 weeks
Title
Change in quality of life as assessed by Short Form-36
Time Frame
Change from baseline quality of life at 4 weeks
Title
Change in pressure pain threshold as measured by digital algometer
Time Frame
Change from baseline pressure pain threshold at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 65 years of age, having neck pain for more than 3 months, and being volunteer Exclusion Criteria: Stenosis, traumatic injury history, previous surgery related to cervical spine, hypermobility, cancer, having inflammatory rheumatologic, severe psychological disorders, being pregnant, and intervention including exercise or physical therapy in the last 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda TOPRAK CELENAY
Phone
+90-534-041-3986
Email
sydtoprak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Derya OZER KAYA
Phone
+90-232-329-3513
Ext
4711
Email
deryaozer2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Organizational Affiliation
Ataturk Trainning and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk Trainning and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyda - TOPRAK CELENAY, Assist. Prof
Phone
+90 0534 041 39 86
Email
sydtoprak@hotmail.com
First Name & Middle Initial & Last Name & Degree
Derya - OZER KAYA, Assoc. Prof
Phone
+90 232 329 35 13
Ext
4711
Email
deryaozer2000@yahoo.com
Facility Name
Ataturk Trainning and Research Hospital
City
Ankara
State/Province
Cankaya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seyda TOPRAK CELENAY
Phone
490-534-041-3986
Email
sydtoprak@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25108749
Citation
Bakar Y, Sertel M, Ozturk A, Yumin ET, Tatarli N, Ankarali H. Short term effects of classic massage compared to connective tissue massage on pressure pain threshold and muscle relaxation response in women with chronic neck pain: a preliminary study. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):415-21. doi: 10.1016/j.jmpt.2014.05.004. Epub 2014 Aug 6.
Results Reference
result
PubMed Identifier
19565156
Citation
Dusunceli Y, Ozturk C, Atamaz F, Hepguler S, Durmaz B. Efficacy of neck stabilization exercises for neck pain: a randomized controlled study. J Rehabil Med. 2009 Jul;41(8):626-31. doi: 10.2340/16501977-0392.
Results Reference
result
PubMed Identifier
12221344
Citation
Jull G, Trott P, Potter H, Zito G, Niere K, Shirley D, Emberson J, Marschner I, Richardson C. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). 2002 Sep 1;27(17):1835-43; discussion 1843. doi: 10.1097/00007632-200209010-00004.
Results Reference
result
PubMed Identifier
19333174
Citation
Sherman KJ, Cherkin DC, Hawkes RJ, Miglioretti DL, Deyo RA. Randomized trial of therapeutic massage for chronic neck pain. Clin J Pain. 2009 Mar-Apr;25(3):233-8. doi: 10.1097/AJP.0b013e31818b7912.
Results Reference
result
PubMed Identifier
26211422
Citation
Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.
Results Reference
derived

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Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain

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