NCT04345042

Brief Summary

Neck pain (NP) is a major public health problem with high prevalence, high cost of health expenditure and loss of productivity.The incidence of NP is increasing among adults and it has been reported to occur in 12-34% of the total population. Exercise programs applied to individuals with NP include craniocervical flexion exercises that focus on the increase in activation of deep cervical flexor muscles and a decrease in the activation of superficial cervical flexors. Falla et al. noted that people with NP also have reduced ability to relax sternocleidomastoideus (SCM) muscle. Although there are many studies indicating that the activation of the SCM muscle should be reduced by activating deep cervical flexors when the literature on NP is examined, there are no studies examining the effect of the inhibition of the SCM muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 4, 2020

Last Update Submit

April 14, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain Assessment

    Visual analog scale was used to detect the patients pain intensity. VAS is a simple and common method to evaluate pain intensity. Subjects were instructed to indicate the intensity of their pain by marking a 10-cm line anchored with terms describing the extremes of pain intensity in the last 24 hours. VAS has been shown to be reliable and valid in measuring pain.

    6 weeks

  • Disability

    Neck Disability Index (NDI) was applied in order to evaluate how the patient's NP affects their daily life. Total point changes between 0 and 35, with a high score indicating a higher level of disability.

    6 weeks

Secondary Outcomes (4)

  • Degree of Cervical Range of Motion

    6 weeks

  • Depressive Symptoms

    6 weeks

  • Kinesiophobia

    6 weeks

  • Evaluation of the static endurance of the neck muscles

    6 weeks

Study Arms (2)

First Group

NO INTERVENTION

In the first group; the investigators applied the TP such as hot pack, ultrasound, exercise and TENS.

Second Group

EXPERIMENTAL

In the second group; the investigators applied the classic massage (Swedish Technique) together with TP.

Other: Classic Massage (Swedish Technique)

Interventions

Classic Massage (Swedish Technique); The massage was applied to the paitents with NP in the second group. Massage procedure included 3 strokes, 3 kneads, and 3 strokes to the upper back and neck area. The application was supported by face cradle and carried out in a semi-horizontal position in which the neck was relaxed. The patient was lying in supine position.

Also known as: Exercise, transcuteneal electric stimulation, ultrasound, hot pack
Second Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Neck pain complaint persists for at least 3 months

You may not qualify if:

  • History of cervical spine surgery
  • Being included in the physiotherapy and rehabilitation program due to neck pain in the last 6 months
  • Diagnosis of vertebrobasillar artery failure
  • Diagnosed with cervical stenosis, torticollis, scoliosis, and diagnosing serious pathology such as malignancy, infection and inflammatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University, School of Physical Therapy and Rehablitation

Kırşehir, Others, 40100, Turkey (Türkiye)

Location

Related Publications (3)

  • Sihawong R, Janwantanakul P, Sitthipornvorakul E, Pensri P. Exercise therapy for office workers with nonspecific neck pain: a systematic review. J Manipulative Physiol Ther. 2011 Jan;34(1):62-71. doi: 10.1016/j.jmpt.2010.11.005.

  • Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, Cote P, Haldeman S, Ammendolia C, Carragee E, Hurwitz E, Nordin M, Peloso P; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S39-51. doi: 10.1097/BRS.0b013e31816454c8.

  • Buyukturan B, Sas S, Kararti C, Buyukturan O. The effects of combined sternocleidomastoid muscle stretching and massage on pain, disability, endurance, kinesiophobia, and range of motion in individuals with chronic neck pain: A randomized, single-blind study. Musculoskelet Sci Pract. 2021 Oct;55:102417. doi: 10.1016/j.msksp.2021.102417. Epub 2021 Jun 12.

MeSH Terms

Conditions

Neck Pain

Interventions

ExerciseHigh-Energy Shock Waves

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaUltrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Öznur Büyükturan

    Mr.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Single- Blind Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Öznur BÜYÜKTURAN

Study Record Dates

First Submitted

April 4, 2020

First Posted

April 14, 2020

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

February 1, 2020

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations