Clinical trial NCT05503602: 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
Overall status: COMPLETED
Phase: NA
Conditions: Instrument-assisted Soft Tissue Mobilization
Flexibility
Foam Roller
Strength
Chronic Non-specific Neck Pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle Strength Assessment
timeFrame: Pre-treatment assessment.
measure: Muscle Strength Assessment
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Muscle Strength Assessment
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
measure: Flexibility Assessment
timeFrame: Pre-treatment assessment.
measure: Flexibility Assessment
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Flexibility Assessment
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
measure: Pain Assessment
timeFrame: Pre-treatment assessment.
measure: Pain Assessment
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Pain Assessment
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
Secondary outcomes:
measure: Functional Status Assessment Questionnaire
timeFrame: Pre-treatment assessment.
measure: Functional Status Assessment Questionnaire
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Functional Status Assessment Questionnaire
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
measure: Joint Range of Motion Assessment
timeFrame: Pre-treatment assessment.
measure: Joint Range of Motion Assessment
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Joint Range of Motion Assessment
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
measure: Quality of Life Assessment Questionnaire
timeFrame: Pre-treatment assessment.
measure: Quality of Life Assessment Questionnaire
timeFrame: Second evaluation immediately after the end of 4 weeks of treatment.
measure: Quality of Life Assessment Questionnaire
timeFrame: Control evaluation 1 month after the end of treatment (third evaluation).
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: Muhammed Üsame TAŞ, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: