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The Inhibition of Sternocleidomastoideus Muscle

Primary Purpose

Neck Pain, Massage, Range of Motion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Classic Massage (Swedish Technique)
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Neck pain complaint persists for at least 3 months

Exclusion Criteria:

  • 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

Sites / Locations

  • Ahi Evran University, School of Physical Therapy and Rehablitation

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

First Group

Second Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Degree of Cervical Range of Motion
A universal goniometer was used to assess the Range of Motion of the cervical vertebrae. Cervical flexion, extension, right and left lateral flexion, and right and left rotation movements were measured 3 times in an active manner while the patients were in a comfortable sitting position. The average value of the measurements was recorded as ROM. The pain-free maximum degree of movement for each range was measured in degrees. This method has demonstrated good reliability.
Depressive Symptoms
Participants' level of depression was assessed using Back Depression Inventory that consists of 21 categories with 4 options in each category. Each item has a score between 0 and 3, and total score varies from 0 to 63. Score ranges are interpreted as 0-9 points = minor depression, 10-16 points = mild depression, 17-29 points = moderate depression, and 30-63 points = severe depression.
Kinesiophobia
Tampa scale of kinesiophobia was used to assess fear of pain or re-injury that may occur because of any movement. Consisting of 17 items, the scale assesses the parameters of injury/re-injury and fear/avoidance in various activities. Total points may vary between 17 and 68, with a high score indicating a higher level of kinesiophobia.
Evaluation of the static endurance of the neck muscles
Neck extensors and neck flexors endurance test were used to evaluate the static endurance of the neck muscles. Each measurement will be taken 2 times and the best measurement was recorded. Time was given to rest the person for 3 minutes between measurements. The time in which the patient can maintain the position was recorded in seconds.

Full Information

First Posted
April 4, 2020
Last Updated
April 14, 2020
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04345042
Brief Title
The Inhibition of Sternocleidomastoideus Muscle
Official Title
The Effects of Inhibition of Sternocleidomastoideus Muscle in Patients With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Patients with NP who were directed to a physiotherapy and rehabilitation program by a specialist physician and meeting the inclusion criteria were included in the study. Criteria for inclusion in the study; NP complaint persists for at least 3 months and is between the ages of 18-55. Exclusion criteria are; Having a history of cervical spine surgery, being included in the physiotherapy and rehabilitation program due to NP in the last 6 months, having a diagnosis of vertebrobasilar artery failure, being diagnosed with cervical stenosis, torticollis, scoliosis, and diagnosing serious pathology such as malignancy, infection and inflammatory disorders. Outcome measures: Pain: Visual analog scale (VAS) 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. 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. Degree of Cervical Range of Motion (ROM): A universal goniometer was used to assess the Range of Motion of the cervical vertebrae. Cervical flexion, extension, right and left lateral flexion, and right and left rotation movements were measured 3 times in an active manner while the patients were in a comfortable sitting position. The average value of the measurements was recorded as ROM. The pain-free maximum degree of movement for each range was measured in degrees. This method has demonstrated good reliability. Depressive Symptoms: Participants' level of depression was assessed using Back Depression Inventory that consists of 21 categories with 4 options in each category. Each item has a score between 0 and 3, and total score varies from 0 to 63. Score ranges are interpreted as 0-9 points = minor depression, 10-16 points = mild depression, 17-29 points = moderate depression, and 30-63 points = severe depression. Kinesiophobia: Tampa scale of kinesiophobia (TSK): The scale was used to assess fear of pain or re-injury that may occur because of any movement. Consisting of 17 items, the scale assesses the parameters of injury/re-injury and fear/avoidance in various activities. Total points may vary between 17 and 68, with a high score indicating a higher level of kinesiophobia. Evaluation of the static endurance of the neck muscles: Neck extensors and neck flexors endurance test were used to evaluate the static endurance of the neck muscles. Each measurement will be taken 2 times and the best measurement was recorded. Time was given to rest the person for 3 minutes between measurements. The time in which the patient can maintain the position was recorded in seconds. Neck flexors endurance test; Patients were lying down in the hook lying position with the therapist's hand placed under their head. The patients were then asked to bring their chin closer to their chest in the Chin Tuck position lifting their head about 2.5 cm and to then hold that position. The test was terminated if the patient experienced any pain or fatigue, or if their head touched the therapist's hand. Two measurements were taken and the longest duration was recorded. Neck extensors endurance test; Patients were lying with their heads bent downwards and their arms resting at their sides. They were asked to approach the edge of the bed so that their head and chest would be hanging from the bed. A sandbag weighing of 2 kg was placed at the back of the neck (between the ears) and the patients were asked to lift their head to the neutral position and then hold it there. The test was terminated in case of any pain or fatigue experienced by the patients, or a 5˚ deterioration in the position of the head. Two measurements were taken and the highest score was recorded. Randomization: The patients were divided into two groups, according to their age and duration of disease by using matched randomization. Intervention: First Group: Traditional physiotherapy (TP) program was applied to patients with NP in the first group. TP program consists of hot-pack, ultrasound, transcutaneal electrical nerve stimulation (TENS) and exercises. Second Group: The individuals who participated in the second group were applied classical massage and stretching exercises suitable for the SCM muscle together with TP. The treatment program applied to the patient in the first group was applied in the same way. The Classic massage procedure was applied to the SCM for 5 minutes using the Swedish technique. The classic massage was performed by a trained physiotherapist. The 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Massage, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Single- Blind Randomized Controlled Trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First Group
Arm Type
No Intervention
Arm Description
In the first group; the investigators applied the TP such as hot pack, ultrasound, exercise and TENS.
Arm Title
Second Group
Arm Type
Experimental
Arm Description
In the second group; the investigators applied the classic massage (Swedish Technique) together with TP.
Intervention Type
Other
Intervention Name(s)
Classic Massage (Swedish Technique)
Other Intervention Name(s)
Exercise, transcuteneal electric stimulation, ultrasound, hot pack
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Assessment
Description
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.
Time Frame
6 weeks
Title
Disability
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Degree of Cervical Range of Motion
Description
A universal goniometer was used to assess the Range of Motion of the cervical vertebrae. Cervical flexion, extension, right and left lateral flexion, and right and left rotation movements were measured 3 times in an active manner while the patients were in a comfortable sitting position. The average value of the measurements was recorded as ROM. The pain-free maximum degree of movement for each range was measured in degrees. This method has demonstrated good reliability.
Time Frame
6 weeks
Title
Depressive Symptoms
Description
Participants' level of depression was assessed using Back Depression Inventory that consists of 21 categories with 4 options in each category. Each item has a score between 0 and 3, and total score varies from 0 to 63. Score ranges are interpreted as 0-9 points = minor depression, 10-16 points = mild depression, 17-29 points = moderate depression, and 30-63 points = severe depression.
Time Frame
6 weeks
Title
Kinesiophobia
Description
Tampa scale of kinesiophobia was used to assess fear of pain or re-injury that may occur because of any movement. Consisting of 17 items, the scale assesses the parameters of injury/re-injury and fear/avoidance in various activities. Total points may vary between 17 and 68, with a high score indicating a higher level of kinesiophobia.
Time Frame
6 weeks
Title
Evaluation of the static endurance of the neck muscles
Description
Neck extensors and neck flexors endurance test were used to evaluate the static endurance of the neck muscles. Each measurement will be taken 2 times and the best measurement was recorded. Time was given to rest the person for 3 minutes between measurements. The time in which the patient can maintain the position was recorded in seconds.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Neck pain complaint persists for at least 3 months Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Öznur Büyükturan
Organizational Affiliation
Mr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahi Evran University, School of Physical Therapy and Rehablitation
City
Kırsehir
State/Province
Others
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21237409
Citation
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.
Results Reference
result
PubMed Identifier
18204398
Citation
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.
Results Reference
result
PubMed Identifier
34147954
Citation
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.
Results Reference
derived

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The Inhibition of Sternocleidomastoideus Muscle

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