Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.

Strength Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503602
• Other study ID #: ÜSAME TAS-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2022
• Source: Inonu University
• Contact: Muhammed Üsame TAS, Lecturer
• Phone: +90 0534 681 25 85
• Email: fzt.muhammedusame.tas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Consists of individuals between the ages of 18-60,

2. Being diagnosed with chronic non-specific neck pain,

3. Having a score of at least 4 on the visual analog scale (VAS) of the mean neck pain intensity,

4. Having non-specific neck pain at least 5 days a week for the last 12 weeks,

5. To be deemed appropriate by the physical therapy physician for early physiotherapy treatment after the diagnosis of chronic non-specific neck pain.

Exclusion Criteria:

1. Individuals with a history of cervical spine surgery, cervical trauma, central nervous system diseases, cervical radiculopathy, acute inflammation and malignancy,

2. Having neck pain due to specific causes (disc protrusion, radicular syndrome, whiplash, congenital deformity of the spine, spinal canal stenosis and neoplasm),

3. Individuals with inflammatory rheumatic disease, active oncological disease, affective disorder, addiction and psychosis,

4. Individuals who have undergone invasive treatment of the spine in the last 4 weeks or spine surgery in the previous 12 months,

5. Individuals from the chronic neck pain group who are currently receiving treatment or have a neck injury resulting in a spinal fracture,

6. 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.

Related Conditions & MeSH terms

• Chronic Non-specific Neck Pain
• Flexibility
• Instrument-assisted Soft Tissue Mobilization
• Neck Pain
• Strength

Intervention

Other:
• Classical Physiotherapy
Only classical physiotherapy application, 5 sessions per week for 4 weeks.
• IASTM Technique Application
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).
• Foam Roller Technique Application
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).

Locations

Country	Name	City	State
Turkey	Inonu University	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength Assessment	A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.	Pre-treatment assessment.
Primary	Muscle Strength Assessment	A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.	Second evaluation immediately after the end of 4 weeks of treatment.
Primary	Muscle Strength Assessment	A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.	Control evaluation 1 month after the end of treatment (third evaluation).
Primary	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.	Pre-treatment assessment.
Primary	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.	Second evaluation immediately after the end of 4 weeks of treatment.
Primary	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.	Control evaluation 1 month after the end of treatment (third evaluation).
Primary	Pain Assessment	Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.	Pre-treatment assessment.
Primary	Pain Assessment	Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.	Second evaluation immediately after the end of 4 weeks of treatment.
Primary	Pain Assessment	Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.	Control evaluation 1 month after the end of treatment (third evaluation).
Secondary	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).	Pre-treatment assessment.
Secondary	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).	Second evaluation immediately after the end of 4 weeks of treatment.
Secondary	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).	Control evaluation 1 month after the end of treatment (third evaluation).
Secondary	Joint Range of Motion Assessment	A goniometer will be used to evaluate the patients' range of motion.	Pre-treatment assessment.
Secondary	Joint Range of Motion Assessment	A goniometer will be used to evaluate the patients' range of motion.	Second evaluation immediately after the end of 4 weeks of treatment.
Secondary	Joint Range of Motion Assessment	A goniometer will be used to evaluate the patients' range of motion.	Control evaluation 1 month after the end of treatment (third evaluation).
Secondary	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.	Pre-treatment assessment.
Secondary	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.	Second evaluation immediately after the end of 4 weeks of treatment.
Secondary	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.	Control evaluation 1 month after the end of treatment (third evaluation).