Back to resultsInvestigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Therapy
Cervical Stabilazation Exercise (CSE)
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, manual therapy, exercise, postural control
Eligibility Criteria
Inclusion Criteria:
- 20 to 55 years of age,
- Having generalized neck pain for more than 3 months,
- Being volunteer
Exclusion Criteria:
- Being pregnant,
- Malignancy,
- Having cervical stenosis,
- Severe cervical spondylosis,
- Cervical fractures and tumor,
- Osteoporosis,
- Positive vertebrobasilar test
- Positive Babinski reflex
- Neurologic deficit related to compression of the spinal root or cord,
- Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
- Being an inability to fulfill the questionnaires,
- Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months
Sites / Locations
- Ankara Yildirim Beyazit University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual therapy plus cervical stabilization exercise group
Only manual therapy group
Arm Description
The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
Outcomes
Primary Outcome Measures
Balance
The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.
Secondary Outcome Measures
Proprioception
Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.
Muscle morphology
The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.
Pain intensity
The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants will be asked to mark the intensity of their pain level.
Disability level
The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.
Full Information
NCT ID
NCT04420403
First Posted
May 29, 2020
Last Updated
December 14, 2021
Sponsor
Ataturk Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04420403
Brief Title
Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain
Official Title
Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise on Balance, Proprioception, and Neck Muscle Morphology in Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the effectiveness of manual therapy plus cervical stabilization exercise compared to manual therapy alone on balance, proprioception, and neck muscle morphology in chronic neck pain.
Detailed Description
Neck pain is defined as pain and/or stiffness localized to the dorsal area of the area between the condyle of the occiput and the third thoracic vertebra. Chronic neck pain (CNP), defined as persistent pain lasting three or more mounts, causes disability and a reduction in life quality. Balance disorders or postural instability, a deficit in proprioception, changes in muscle recruitment, a decrease in dimension of deep cervical muscle, and an increase in stiffness of superficial neck muscle may lead to pain in patients with CNP. Both manual therapy and exercise have favorable effects on management with CNP. According to our knowledge, no study has investigated the effects of manual therapy plus cervical stabilization exercise on balance, proprioception, and neck muscle morphology in CNP, yet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
neck pain, manual therapy, exercise, postural control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants were randomly assigned to manual therapy plus cervical stabilization exercise group (intervention group) and only the manual therapy group (control group).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual therapy plus cervical stabilization exercise group
Arm Type
Experimental
Arm Description
The patients diagnosed with chronic neck pain (CNP) with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
Arm Title
Only manual therapy group
Arm Type
Active Comparator
Arm Description
The patients diagnosed with CNP with 18-55 years of age followed by routine controls and who were volunteered will be included in the study.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.
Intervention Type
Other
Intervention Name(s)
Cervical Stabilazation Exercise (CSE)
Intervention Description
The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.
Primary Outcome Measure Information:
Title
Balance
Description
The balance will be evaluated with Biodex BioSwayTM Balance Evaluation System. It reliably measures the patient's ability to balance on soft and/or hard ground.
Time Frame
change from baseline at 6 weeks
Secondary Outcome Measure Information:
Title
Proprioception
Description
Proprioception will be assessed with dual digital inclinometer. The feet of the inclinometers will be placed as simultaneously as possible over the head of the patients and the cervical seventh vertebra. Firstly, patients will be asked to move their heads forward as possible as from the neutral position and then they will try to find neutral position from reached position. The angle on digital display of inclinometer will be recorded as degree. Each test will be repeated 3 times and the average deviation error score will be recorded.
Time Frame
change from baseline at 6 weeks
Title
Muscle morphology
Description
The thickness and stiffness of the neck muscles will be evaluated by a specialist radiologist with real-time ultrasonography. It is a reliable, valid and, non-invasive method that provides an assessment of muscle morphology. Measurements will be made by using the Logiq S7 / Expert ultrasound device. The cross-sectional area of deep neck muscle with sonography, the stiffness of the superficial muscles with elastography were assessed.
Time Frame
change from baseline at 6 weeks
Title
Pain intensity
Description
The pain intensity will be assessed with the Visual Analog Scale, which consists of a horizontal line of 10 cm in length. For pain level assessment, "0" defines "no pain" and "10" defines "unbearable pain''. The participants will be asked to mark the intensity of their pain level.
Time Frame
change from baseline at 6 weeks
Title
Disability level
Description
The disability level will be measured with the Turkish version of Neck Disability Index (NDI). It consists of 10 sections which include the severity of pain, personal care, lifting, reading, headache, concentration, work-life, driving, sleeping and leisure activities. There are 6 responses for each section, scored 0 (no pain and no functional limitation) and 5 (worst pain and maximum limitation). The total score ranges from 0 to 50. Patients will be asked to select the most appropriate option for each section.
Time Frame
change from baseline at 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:
20 to 55 years of age,
Having generalized neck pain for more than 3 months,
Being volunteer
Exclusion Criteria:
Being pregnant,
Malignancy,
Having cervical stenosis,
Severe cervical spondylosis,
Cervical fractures and tumor,
Osteoporosis,
Positive vertebrobasilar test
Positive Babinski reflex
Neurologic deficit related to compression of the spinal root or cord,
Having neurologic, dermatologic, infectious, inflammatory rheumatologic and endocrine diseases,
Being an inability to fulfill the questionnaires,
Any problems that will hinder exercise (advanced cardiopulmonary or orthopedic problems), having intervention including exercise program or physiotherapy in the three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seyda toprak celenay, PhD, PT
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yildirim Beyazit University
City
Ankara
ZIP/Postal Code
06760
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Effectiveness of Manual Therapy Plus Cervical Stabilization Exercise in Chronic Neck Pain
We'll reach out to this number within 24 hrs