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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02424032
Other study ID # GO 13/381
Secondary ID
Status Recruiting
Phase Phase 2
First received April 8, 2015
Last updated April 18, 2015
Start date February 2013

Study information

Verified date April 2015
Source Ataturk Training and Research Hospital
Contact Seyda TOPRAK CELENAY
Phone +90-534-041-3986
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 53
Est. completion date
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
"Exercise" and "connective tissue massage"
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.
"Exercise"
Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.

Locations

Country Name City State
Turkey Ataturk Trainning and Research Hospital Ankara Cankaya
Turkey Ataturk Trainning and Research Hospital Ankara Cankaya

Sponsors (1)

Lead Sponsor Collaborator
Seyda TOPRAK CELENAY

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Bakar Y, Sertel M, Oztürk A, Yümin 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 Man — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Neck pain intensity as measured by Visual Analog Scale Change from baseline neck pain intensity at 4 weeks Yes
Secondary Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory Change from baseline level of anxiety at 4 weeks Yes
Secondary Change in quality of life as assessed by Short Form-36 Change from baseline quality of life at 4 weeks Yes
Secondary Change in pressure pain threshold as measured by digital algometer Change from baseline pressure pain threshold at 4 weeks Yes
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