Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04803669
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2021-03-14
Brief Title:
The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain
Sponsor:
Emresenocak
Organization:
Marmara University
Study Overview
Official Title:
The Investigation of Instrument-assisted Soft Tissue Mobilization Technique on Pain and Disability in Patients With Cervical Neck Pain
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IASTM
Brief Summary:
In the literature studies reporting that symptoms such as limitation of motion in the neck reduced functionality and disability and depression occur in cervical pain are frequently encountered Treatments such as medical therapy intramuscular injections and traditional physical therapy modalities have been used in the treatment of these symptoms In recent years the popularity of the instrument-assisted soft tissue mobilization IASTM technique in the treatment of soft tissue-related problems has increased and has been widely used in studies This technique is a low-cost easy-to-apply and accessible method that is frequently used in extremity soft tissue problems and trigger point treatment The investigators did not find any study on the effectiveness of the IASTM technique on pain and functionality in cervical region disorders For this reason the primary purpose of the study is While the effectiveness of the IASTM technique on pain and functionality in patients with neck pain caused by cervical disc herniation the secondary purpose is to reveal the effect of IASTM on anxiety-depression
Detailed Description:
Ethics Approval The study started with the approval of the Ethics Committee of Marmara University Faculty of Medicine with the 092019491 protocol number
Twenty-four patients who were diagnosed with cervical disc herniation bulging protrusion based on radiological evaluation and who achieved 100 continuity in the treatment program will be included in the study A similar study was taken as a reference when calculating the sample size
Randomization Participants will be randomized and divided into two groups using online randomization software Conventional treatment methods will be applied to Conventional Treatment Group and IASTM will be applied to IASTM Group participants in addition to the conventional treatment protocol Conventional treatment will be applied to both groups for 4 weeks 5 days a week
Interventions Conventional treatment protocol was determined as hot pack application electrotherapy agents and exercise program Hotpack intervention will be made on the neck and upper back area by wrapping in hot water bags and a towel for 25 minutes The electrotherapy program consists of transcutaneous electrical stimulation TENS and ultrasound US Conventional TENS 2 channels and 4 electrodes on the neck and upper trapezius muscle It will be applied for 25 minutes Acutens Brand frequency 100 Hz wave width 200 ms 1-100 mA current The current intensity will be adjusted in a way that does not cause discomfort for the patient US will be applied at an intensity of 1-25 W cm2 and a frequency of 1 MHz for 5 minutes to increase circulation in deep tissues After the electrotherapy application the patients will be given an exercise program under the supervision of a physiotherapist for 25 minutes This program consists of deep flexor and extensor strengthening posture stretching and mobilization exercises with elastic bands The instrument-assisted soft tissue mobilization technique will be applied over the superficial and deep fascia region between C1-T1 neck-shoulder segments The instrument used is made of stainless steel and will be applied using a brushing technique parallel to the muscle fibers applications at an angle of 30 A water-based gel will be used to prevent adverse effects on the tissue due to friction This technique will be applied as 2 sessions per week and 5 minutes per session 8 sessions in total for 4 weeks
Assessment
Sociodemographic Data Form Patients gender age body mass index and time of pain onset will be noted
Visual Analogue Scale The Visual Analogue Scale VAS is an easy-to-apply and reliable assessment scale used to determine the pain level of patients VAS was created to digitize values that are not expressed numerically Scoring is made between 0-10 points 0 represents the absence of pain 10 represents the presence of unbearable pain Using VAS participants will be questioned for additional information such as the time of onset of neck pain its frequency rest and activity pain
Copenhagen Neck Functional Disability Scale It is a valid and reliable scale that evaluates the disability of patients due to neck pain The scale consists of 15 items The items are answered as Yes No Sometimes and scored between 0-2 points The total score is between 0 and 30 points If the total score is 0 it means no neck pain and disability 30 means maximum neck pain and disability
Hospital Anxiety and Depression Scale It includes anxiety and depression subscales The scale consists of 14 items in total Even-numbered items evaluate depression and odd-numbered items assess anxiety Answers are in four-point Likert format and are scored between 0 and 3 The cut-off point for the anxiety subscale of the scale was reported to be 10 and 7 for the depression subscale
Statistical Analysis The data obtained in the study will be evaluated with SPSS 110 statistical program at an 80 confidence interval and p 005 significance level The normal distribution of the data will be examined with the Kolmogorov Smirnov test and histogram curves
Twenty-four patients who were diagnosed with cervical disc herniation bulging protrusion based on radiological evaluation and who achieved 100 continuity in the treatment program will be included in the study A similar study was taken as a reference when calculating the sample size
Randomization Participants will be randomized and divided into two groups using online randomization software Conventional treatment methods will be applied to Conventional Treatment Group and IASTM will be applied to IASTM Group participants in addition to the conventional treatment protocol Conventional treatment will be applied to both groups for 4 weeks 5 days a week
Interventions Conventional treatment protocol was determined as hot pack application electrotherapy agents and exercise program Hotpack intervention will be made on the neck and upper back area by wrapping in hot water bags and a towel for 25 minutes The electrotherapy program consists of transcutaneous electrical stimulation TENS and ultrasound US Conventional TENS 2 channels and 4 electrodes on the neck and upper trapezius muscle It will be applied for 25 minutes Acutens Brand frequency 100 Hz wave width 200 ms 1-100 mA current The current intensity will be adjusted in a way that does not cause discomfort for the patient US will be applied at an intensity of 1-25 W cm2 and a frequency of 1 MHz for 5 minutes to increase circulation in deep tissues After the electrotherapy application the patients will be given an exercise program under the supervision of a physiotherapist for 25 minutes This program consists of deep flexor and extensor strengthening posture stretching and mobilization exercises with elastic bands The instrument-assisted soft tissue mobilization technique will be applied over the superficial and deep fascia region between C1-T1 neck-shoulder segments The instrument used is made of stainless steel and will be applied using a brushing technique parallel to the muscle fibers applications at an angle of 30 A water-based gel will be used to prevent adverse effects on the tissue due to friction This technique will be applied as 2 sessions per week and 5 minutes per session 8 sessions in total for 4 weeks
Assessment
Sociodemographic Data Form Patients gender age body mass index and time of pain onset will be noted
Visual Analogue Scale The Visual Analogue Scale VAS is an easy-to-apply and reliable assessment scale used to determine the pain level of patients VAS was created to digitize values that are not expressed numerically Scoring is made between 0-10 points 0 represents the absence of pain 10 represents the presence of unbearable pain Using VAS participants will be questioned for additional information such as the time of onset of neck pain its frequency rest and activity pain
Copenhagen Neck Functional Disability Scale It is a valid and reliable scale that evaluates the disability of patients due to neck pain The scale consists of 15 items The items are answered as Yes No Sometimes and scored between 0-2 points The total score is between 0 and 30 points If the total score is 0 it means no neck pain and disability 30 means maximum neck pain and disability
Hospital Anxiety and Depression Scale It includes anxiety and depression subscales The scale consists of 14 items in total Even-numbered items evaluate depression and odd-numbered items assess anxiety Answers are in four-point Likert format and are scored between 0 and 3 The cut-off point for the anxiety subscale of the scale was reported to be 10 and 7 for the depression subscale
Statistical Analysis The data obtained in the study will be evaluated with SPSS 110 statistical program at an 80 confidence interval and p 005 significance level The normal distribution of the data will be examined with the Kolmogorov Smirnov test and histogram curves
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None