Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 1, 2024
September 1, 2024
9 months
August 12, 2022
September 30, 2024
Conditions
Outcome Measures
Primary Outcomes (9)
Muscle Strength Assessment
A digital muscle dynamometer will be used to evaluate the muscle strength of the patients.
Pre-treatment assessment.
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.
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).
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.
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.
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).
Pain Assessment
Visual Analog Scale (VAS) will be used to evaluate the pain of individuals.
Pre-treatment assessment.
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.
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 Outcomes (9)
Functional Status Assessment Questionnaire
Pre-treatment assessment.
Functional Status Assessment Questionnaire
Second evaluation immediately after the end of 4 weeks of treatment.
Functional Status Assessment Questionnaire
Control evaluation 1 month after the end of treatment (third evaluation).
Joint Range of Motion Assessment
Pre-treatment assessment.
Joint Range of Motion Assessment
Second evaluation immediately after the end of 4 weeks of treatment.
- +4 more secondary outcomes
Study Arms (3)
Control Group
OTHERAn average of 20 people will be taken into the control group.
IASTM Treatment Group
EXPERIMENTALAn average of 20 people will receive IASTM application treatment.
Foam Roller Treatment Group
EXPERIMENTALAn average of 20 people will receive Foam Roller application treatment.
Interventions
Only classical physiotherapy application, 5 sessions per week for 4 weeks.
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Inonu University
Malatya, 44280, Turkey (Türkiye)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammed Üsame TAŞ, Lecturer
Inonu University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 16, 2022
Study Start
December 1, 2021
Primary Completion
September 1, 2022
Study Completion
October 1, 2022
Last Updated
October 1, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share