NCT02424032

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

April 8, 2015

Last Update Submit

April 18, 2015

Conditions

Keywords

Neck painstabilization exerciseconnective tissue massage

Outcome Measures

Primary Outcomes (1)

  • Change in Neck pain intensity as measured by Visual Analog Scale

    Change from baseline neck pain intensity at 4 weeks

Secondary Outcomes (3)

  • Change in level of anxiety as assessed by Spielberger State Trait Anxiety Inventory

    Change from baseline level of anxiety at 4 weeks

  • Change in quality of life as assessed by Short Form-36

    Change from baseline quality of life at 4 weeks

  • Change in pressure pain threshold as measured by digital algometer

    Change from baseline pressure pain threshold at 4 weeks

Study Arms (2)

Exercise and connective tissue massage

EXPERIMENTAL

Stabilization exercise and connective tissue massage have been applied

Behavioral: "Exercise" and "connective tissue massage"

Exercise

ACTIVE COMPARATOR

Only stabilization exercise has been applied

Behavioral: "Exercise"

Interventions

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 and connective tissue massage
"Exercise"BEHAVIORAL

Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.

Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ataturk Trainning and Research Hospital

Ankara, Cankaya, 06800, Turkey (Türkiye)

RECRUITING

Ataturk Trainning and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Seyda TOPRAK CELENAY

    Ataturk Trainning and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 22, 2015

Study Start

February 1, 2013

Primary Completion

May 1, 2015

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations