Back to resultsInvestigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
Primary Purpose
Instrument-assisted Soft Tissue Mobilization, Flexibility, Foam Roller
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Classical Physiotherapy
IASTM Technique Application
Foam Roller Technique Application
Sponsored by
About this trial
This is an interventional treatment trial for Instrument-assisted Soft Tissue Mobilization
Eligibility Criteria
Inclusion Criteria:
- Consists of individuals between the ages of 18-60,
- Being diagnosed with chronic non-specific neck pain,
- Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,
- Having non-specific neck pain at least 5 days a week for the last 12 weeks,
- To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.
Exclusion Criteria:
- Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,
- Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),
- Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,
- Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,
- Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,
- Individuals who have started a new treatment for neck pain in the past month or are planning to start a new treatment within 9 weeks.
Sites / Locations
- Inonu UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control Group
IASTM Treatment Group
Foam Roller Treatment Group
Arm Description
An average of 20 people will be taken into the control group.
An average of 20 people will receive IASTM application treatment.
An average of 20 people will receive Foam Roller application treatment.
Outcomes
Primary Outcome Measures
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Flexibility Assessment
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Secondary Outcome Measures
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Functional Status Assessment Questionnaire
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Joint Range of Motion Assessment
A goniometer will be used to evaluate the patients' range of motion.
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Quality of Life Assessment Questionnaire
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05503602
Brief Title
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
Official Title
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application on Strength, Flexibility, Pain and Secondary Outcome Measures in Individuals With Chronic Non-Specific Neck Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
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
Neck pain is in fourth place among the pathologies that result in the state of disability. Acute neck pain improves greatly within 2 months, while neck pain that persists for more than 3 months takes the form of chronic neck pain. Pain adversely affects people's activities of daily living. Treatment applications such as electrotherapy, hot and cold applications are applied for purposes such as reducing pain and muscle spasm and correcting functions. In addition to such treatment options, instrument-assisted soft tissue mobilization (IASTM) and foam roller therapy have been started to be applied in many disease groups in recent years and have attracted great attention. iASTM and Foam Roller is a technique that involves the use of tools in disorders of musculoskeletal pathology and to help heal soft tissues.
The aim of this study is to investigate the effects of foam roller technique with instrument-assisted soft tissue mobilization technique in individuals of different ages with chronic non-specific neck pain. According to the data obtained, the techniques the investigators will use, together with physiotherapy programs, contribute to the treatment of individuals with chronic non-specific neck pain and to the literature.is expected to provide.
Detailed Description
In the study, Foam Roller will be applied to individuals with chronic non-specific neck pain with iASTM and the effect of these techniques will be examined. Demographic information of individuals will be recorded; individuals will be evaluated in detail in terms of muscle strength, flexibility, pain and secondary outcome measures. Individuals in terms of secondary outcome measures; functional status,joint range of motion and quality of life will be evaluated.
The work plan; pre-treatment evaluation, followed by treatment, second evaluation immediately after the end of treatment and control evaluation (third evaluation) 1 month after the end of treatment. The data collection period is planned as 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Instrument-assisted Soft Tissue Mobilization, Flexibility, Foam Roller, Strength, Chronic Non-specific Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Other
Arm Description
An average of 20 people will be taken into the control group.
Arm Title
IASTM Treatment Group
Arm Type
Experimental
Arm Description
An average of 20 people will receive IASTM application treatment.
Arm Title
Foam Roller Treatment Group
Arm Type
Experimental
Arm Description
An average of 20 people will receive Foam Roller application treatment.
Intervention Type
Other
Intervention Name(s)
Classical Physiotherapy
Intervention Description
Only classical physiotherapy application, 5 sessions per week for 4 weeks.
Intervention Type
Other
Intervention Name(s)
IASTM Technique Application
Intervention Description
Instrument-assisted soft tissue mobilization application 2 sessions per week together with 3 sessions of classical physiotherapy per week for 4 weeks. IASTM application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).
Intervention Type
Other
Intervention Name(s)
Foam Roller Technique Application
Intervention Description
2 sessions of foam roller technique per week along with 3 sessions of classical physiotherapy per week for 4 weeks. Foam roller application; A total of 4 minutes will be applied to the sternocleidomastoideus, levator scapula, scalene muscles and upper part of the trapezius for a total of 4 minutes (2 minutes to the right, 2 minutes to the left region).
Primary Outcome Measure Information:
Title
Muscle Strength Assessment
Description
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Time Frame
Pre-treatment assessment.
Title
Muscle Strength Assessment
Description
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Muscle Strength Assessment
Description
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
Title
Flexibility Assessment
Description
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Time Frame
Pre-treatment assessment.
Title
Flexibility Assessment
Description
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Flexibility Assessment
Description
A tape measure will be used to assess patients' flexibility. The ear-shoulder, chin-sternum (proximal end) and chin-wall distances of the patients will be measured with a tape measure.
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
Title
Pain Assessment
Description
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Time Frame
Pre-treatment assessment.
Title
Pain Assessment
Description
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Pain Assessment
Description
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
Secondary Outcome Measure Information:
Title
Functional Status Assessment Questionnaire
Description
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Time Frame
Pre-treatment assessment.
Title
Functional Status Assessment Questionnaire
Description
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Functional Status Assessment Questionnaire
Description
Neck Disability Index (NDI) will be used to evaluate the functional status of patients. The NDI consists of 10 titles: pain severity, self-care, lifting, reading, headache, concentration, working, driving, sleeping and recreation. Individuals included in the study are asked to give points between 0 (no disability) and 5 (complete disability) to each title. The total score ranges from 0 (no disability) to 50 (complete disability).
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
Title
Joint Range of Motion Assessment
Description
A goniometer will be used to evaluate the patients' range of motion.
Time Frame
Pre-treatment assessment.
Title
Joint Range of Motion Assessment
Description
A goniometer will be used to evaluate the patients' range of motion.
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Joint Range of Motion Assessment
Description
A goniometer will be used to evaluate the patients' range of motion.
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
Title
Quality of Life Assessment Questionnaire
Description
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Time Frame
Pre-treatment assessment.
Title
Quality of Life Assessment Questionnaire
Description
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Time Frame
Second evaluation immediately after the end of 4 weeks of treatment.
Title
Quality of Life Assessment Questionnaire
Description
The Nottingham Health Profile (NHP) will be used to assess patients' quality of life. The Nottingham health profile is a scale used to assess patients' levels of emotional, social and physical activity. The questions are divided into 6 subgroups as energy level (3 questions), pain (8 questions), emotional reaction (9 questions), sleep (5 questions), social isolation (5 questions) and physical activity limitation (8 questions). A total of 38 questions in 6 groups have separate point values, and each item is answered "yes" or "no". A scoring system has been established so that each subgroup will have a total of 100 points.
Time Frame
Control evaluation 1 month after the end of treatment (third evaluation).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Consists of individuals between the ages of 18-60,
Being diagnosed with chronic non-specific neck pain,
Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,
Having non-specific neck pain at least 5 days a week for the last 12 weeks,
To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.
Exclusion Criteria:
Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,
Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),
Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,
Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,
Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,
Individuals who have started a new treatment for neck pain in the past month or are planning to start a new treatment within 9 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammed Üsame TAŞ, Lecturer
Phone
+90 0534 681 25 85
Ext
4848
Email
fzt.muhammedusame.tas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammed Üsame TAŞ, Lecturer
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammed Üsame TAŞ, Lecturer
Phone
+90 0534 681 25 85
Ext
4848
Email
fzt.muhammedusame.tas@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
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