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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05503602




Registration number
NCT05503602
Ethics application status
Date submitted
12/08/2022
Date registered
16/08/2022

Titles & IDs
Public title
Investigation of the Effect of Instrument Assisted Soft Tissue Mobilization Technique and Foam Roller Application in Individuals With Chronic Non-Specific Neck Pain.
Scientific 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.
Secondary ID [1] 0 0
ÜSAME TAS-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Instrument-assisted Soft Tissue Mobilization 0 0
Flexibility 0 0
Foam Roller 0 0
Strength 0 0
Chronic Non-specific Neck Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Classical Physiotherapy
Other interventions - IASTM Technique Application
Other interventions - Foam Roller Technique Application

Other: Control Group - An average of 20 people will be taken into the control group.

Experimental: IASTM Treatment Group - An average of 20 people will receive IASTM application treatment.

Experimental: Foam Roller Treatment Group - An average of 20 people will receive Foam Roller application treatment.


Other interventions: Classical Physiotherapy
Only classical physiotherapy application, 5 sessions per week for 4 weeks.

Other interventions: 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).

Other interventions: 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).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Muscle Strength Assessment
Timepoint [1] 0 0
Pre-treatment assessment.
Primary outcome [2] 0 0
Muscle Strength Assessment
Timepoint [2] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Primary outcome [3] 0 0
Muscle Strength Assessment
Timepoint [3] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).
Primary outcome [4] 0 0
Flexibility Assessment
Timepoint [4] 0 0
Pre-treatment assessment.
Primary outcome [5] 0 0
Flexibility Assessment
Timepoint [5] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Primary outcome [6] 0 0
Flexibility Assessment
Timepoint [6] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).
Primary outcome [7] 0 0
Pain Assessment
Timepoint [7] 0 0
Pre-treatment assessment.
Primary outcome [8] 0 0
Pain Assessment
Timepoint [8] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Primary outcome [9] 0 0
Pain Assessment
Timepoint [9] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).
Secondary outcome [1] 0 0
Functional Status Assessment Questionnaire
Timepoint [1] 0 0
Pre-treatment assessment.
Secondary outcome [2] 0 0
Functional Status Assessment Questionnaire
Timepoint [2] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Secondary outcome [3] 0 0
Functional Status Assessment Questionnaire
Timepoint [3] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).
Secondary outcome [4] 0 0
Joint Range of Motion Assessment
Timepoint [4] 0 0
Pre-treatment assessment.
Secondary outcome [5] 0 0
Joint Range of Motion Assessment
Timepoint [5] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Secondary outcome [6] 0 0
Joint Range of Motion Assessment
Timepoint [6] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).
Secondary outcome [7] 0 0
Quality of Life Assessment Questionnaire
Timepoint [7] 0 0
Pre-treatment assessment.
Secondary outcome [8] 0 0
Quality of Life Assessment Questionnaire
Timepoint [8] 0 0
Second evaluation immediately after the end of 4 weeks of treatment.
Secondary outcome [9] 0 0
Quality of Life Assessment Questionnaire
Timepoint [9] 0 0
Control evaluation 1 month after the end of treatment (third evaluation).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2022
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Turkey
State/province [1] 0 0
Malatya

Funding & Sponsors
Primary sponsor type
Other
Name
Inonu University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Muhammed Üsame TAS, Lecturer
Address 0 0
Inonu University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05503602