- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02424032
Stabilization Exercises With and Without Connective Tissue Massage for Chronic Mechanical Neck Pain
April 18, 2015 updated by: Seyda TOPRAK CELENAY
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
53
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Derya OZER KAYA
- Phone Number: 4711 +90-232-329-3513
- Email: deryaozer2000@yahoo.com
Study Locations
-
-
Cankaya
-
Ankara, Cankaya, Turkey, 06800
- Recruiting
- Ataturk Trainning and Research Hospital
-
Contact:
- Seyda - TOPRAK CELENAY, Assist. Prof
- Phone Number: +90 0534 041 39 86
- Email: sydtoprak@hotmail.com
-
Ankara, Cankaya, Turkey
- Recruiting
- Ataturk Trainning and Research Hospital
-
Contact:
- Seyda TOPRAK CELENAY
- Phone Number: 490-534-041-3986
- Email: sydtoprak@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise and connective tissue massage
Stabilization exercise and connective tissue massage have been applied
|
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.
|
Active Comparator: Exercise
Only stabilization exercise has been applied
|
Cervical and scapulothoracic stabilization exercises were performed.
The program was carried out for 12 sessions, 3 days/week in 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Neck pain intensity as measured by Visual Analog Scale
Time Frame: Change from baseline neck pain intensity at 4 weeks
|
Change from baseline neck pain intensity at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory
Time Frame: Change from baseline level of anxiety at 4 weeks
|
Change from baseline level of anxiety at 4 weeks
|
Change in quality of life as assessed by Short Form-36
Time Frame: Change from baseline quality of life at 4 weeks
|
Change from baseline quality of life at 4 weeks
|
Change in pressure pain threshold as measured by digital algometer
Time Frame: Change from baseline pressure pain threshold at 4 weeks
|
Change from baseline pressure pain threshold at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seyda TOPRAK CELENAY, Ataturk Trainning and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
April 8, 2015
First Submitted That Met QC Criteria
April 18, 2015
First Posted (Estimate)
April 22, 2015
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 18, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 13/381
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain Musculoskeletal
-
Uppsala UniversityDalarna County Council, Sweden; Center for Clinical Research Dalarna, Sweden; REHSAM, SwedenTerminatedMusculoskeletal Neck Pain | Musculoskeletal Shoulder PainSweden
-
NORCE Norwegian Research Centre ASHelse Sor-Ost; Sykehuset i Vestfold HFCompletedNeck Pain Musculoskeletal | Back Pain Lower BackNorway
-
Sykehuset i Vestfold HFActive, not recruitingBack Pain | Musculoskeletal Pain | Chronic Pain | Musculoskeletal Diseases or Conditions | Pain, Chronic | Musculoskeletal Disorder | Musculoskeletal Neck PainNorway
-
Royal College of Surgeons, IrelandNot yet recruitingNeck Pain Musculoskeletal
-
Universidad Complutense de MadridRecruiting
-
Istanbul University - Cerrahpasa (IUC)CompletedMusculoskeletal Pain | Occupational Diseases | Pain, Shoulder | Pain, Joint | Pain, NeckTurkey
-
Hacettepe UniversityCompletedMusculoskeletal Pain | Chronic Neck Pain | Pain Modulation | Cortical Plasticity | Conditioned Pain Modulation | Temporal SummationTurkey
-
University of Wisconsin, MadisonCompletedNeck Pain Musculoskeletal | Back Pain, UnspecifiedUnited States
-
Region SkaneCompletedContinous Popliteal Block for Microvascular Free Flap Reconstruction in Ear, Nose and Throat SurgeryHead and Neck Cancer | Pain, MusculoskeletalSweden
-
Universität Duisburg-EssenCompletedNeck Pain | Neck Pain Musculoskeletal | Mechanical/Motor Problems With Neck and TrunkGermany
Clinical Trials on "Exercise" and "connective tissue massage"
-
Istanbul University-CerrahpasaBahçeşehir University; Yeditepe UniversityCompleted
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting
-
Seyda TOPRAK CELENAYUnknown
-
Hacettepe UniversityUnknownHeadache Disorders, PrimaryTurkey
-
Biruni UniversityCompleted
-
Eastern Mediterranean UniversityUnknown
-
Ankara Yildirim Beyazıt UniversityCompletedConnective Tissue Diseases | Migraine | Migraine Without Aura | Migraine With AuraTurkey
-
Halic UniversityActive, not recruitingCerebral Palsy | Chronic ConstipationTurkey
-
Presidio Ospedaliero di AsiagoCompleted
-
Ankara Yildirim Beyazıt UniversityNot yet recruiting