Neck PainIASTMNCT04803669
The Effect of Instrument-assisted Soft Tissue Mobilization Technique on Neck Pain
A study testing Intrument-assisted soft tissue mobilization technique and Conventional Treatment in people with Neck Pain, run by Emresenocak at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Intrument-assisted soft tissue mobilization technique and Conventional Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2021to 25 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having bulging or protruding cervical disc herniation,
- Pain severity> 2 according to VAS,
- Having neck pain complaint for at least three months
Who cannot join
- Having any neck-shoulder area injury or surgery,
- Using cortisone medication,
- Having extrusion and sequestered disc herniation,
- Being diagnosed with fibromyalgia,
- Having malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Instrument-assisted Soft Tissue Mobilization Technique on Pain and Disability in Patients With Cervical Neck Pain
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.
Read the detailed description
Ethics Approval: The study started with the approval of the Ethics Committee of Marmara University Faculty of Medicine with the 09.2019.491 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 1-2.5 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 11.0 statistical program at an 80% confidence interval and p <0.05 significance level. The normal distribution of the data will be examined with the Kolmogorov Smirnov test and histogram curves.
- Conditions
- Neck Pain
- Being tested
- Intrument-assisted soft tissue mobilization technique, Conventional Treatment
- Keywords
- neck pain, neck disability, Instrument-assisted soft tissue mobilization technique, conventional therapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrument-assisted soft tissue mobilization techniqueProcedure or surgery
This technique; It is applied with the help of a tool made of stainless steel. The instrument is rubbed on the skin at an angle of about 30 degrees, creating a massage-like effect on the soft tissue (2 sessions per week and 5 minutes per session, 8 sessions in total for 4 weeks).
Conventional TreatmentProcedure or surgery
Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Group | Active comparator | Includes Hotpack, TENS, Ultrasound and Exercise programs. Receives: Procedure: Conventional Treatment |
| IASTM Group | Experimental | Inludes Hotpack, TENS, Ultrasound, Exercise program and Instrument-assisted Soft Tissue Mobilization Technique Receives: Procedure: Intrument-assisted soft tissue mobilization technique; Procedure: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain Changing
Pain will be evaluated with Visual Analog Scale. The scale is scored between 0 and 10. "0" means no pain, "10" means very severe pain.
Measured: Change from Baseline Neck Pain at 6. week
Secondary outcomes (3)
Neck Disability Changing
Disability will be assessed by the Copenhagen Neck Functional Disability Scale. The scale is scored between 0-30. "0" means no disability, "30" means maximum neck pain and disability.
Measured: Change from Baseline Neck Disability at 6. week
Anxiety Changing
Anxiety will be evaluated with the Hospital Anxiety and Depression Scale. High score means high anxiety.
Measured: Change from Baseline Anxiety at 6. week
Depression Changing
Depression will be evaluated with the Hospital Anxiety and Depression Scale. High score means high depression.
Measured: Change from Baseline Depression at 6. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start18 Jan 2021
- Primary completion23 Sep 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Conventional Treatment Conventional Treatment + Instrument-assisted soft tissue mobilization technique
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emresenocak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emresenocak, Marmara University
- Investigators
- Adem Aktürk, Medical Doktor (specialist), Principal investigator, İstanbul Gelişim UniversityMehmet Özkeskin, PhD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803669
- Sponsor's protocol ID
- 09.2019.491
- Acronym
- IASTM
- Status last verified
- Apr 2022
- First submitted
- 14 Mar 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Instrument-assisted Soft Tissue Mobilization Technique on Pain and Disability in Patients With Cervical Neck Pain
- ClinicalTrials.gov ID
- NCT04803669
- Acronym / sponsor ID
- IASTM / 09.2019.491
- Conditions
- Neck Pain
- Keywords
- neck pain, neck disability, Instrument-assisted soft tissue mobilization technique, conventional therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- EmresenocakUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 09.2019.491 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 1-2.5 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 11.0 statistical program at an 80% confidence interval and p <0.05 significance level. The normal distribution of the data will be examined with the Kolmogorov Smirnov test and histogram curves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Conventional Treatment Conventional Treatment + Instrument-assisted soft tissue mobilization technique
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Group | Active comparator | Procedure: Conventional TreatmentIncludes Hotpack, TENS, Ultrasound and Exercise programs. |
| IASTM Group | Experimental | Procedure: Intrument-assisted soft tissue mobilization technique, Procedure: Conventional TreatmentInludes Hotpack, TENS, Ultrasound, Exercise program and Instrument-assisted Soft Tissue Mobilization Technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having bulging or protruding cervical disc herniation,
- Pain severity> 2 according to VAS,
- Having neck pain complaint for at least three months
Key exclusion criteria (5 listed)
- Having any neck-shoulder area injury or surgery,
- Using cortisone medication,
- Having extrusion and sequestered disc herniation,
- Being diagnosed with fibromyalgia,
- Having malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrument-assisted soft tissue mobilization techniqueThis technique; It is applied with the help of a tool made of stainless steel. The instrument is rubbed on the skin at an angle of about 30 degrees, creating a massage-like effect on the soft tissue (2 sessions per week and 5 minutes per session, 8 sessions in total for 4 weeks). | Procedure or surgery | IASTM Group |
| Conventional TreatmentHotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods. | Procedure or surgery | Conventional Treatment Group, IASTM Group |
Primary outcome
Neck Pain Changing
Time frame: Change from Baseline Neck Pain at 6. week
Pain will be evaluated with Visual Analog Scale. The scale is scored between 0 and 10. "0" means no pain, "10" means very severe pain.
3 secondary outcomes
Neck Disability Changing
Time frame: Change from Baseline Neck Disability at 6. week
Anxiety Changing
Time frame: Change from Baseline Anxiety at 6. week
Depression Changing
Time frame: Change from Baseline Depression at 6. week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adem Aktürk, Medical Doktor (specialist) principal investigator
İstanbul Gelişim University
Mehmet Özkeskin, PhD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrument-assisted soft tissue mobilization technique and Conventional Treatment in people with Neck Pain, run by Emresenocak at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Pain Changing (time frame: Change from Baseline Neck Pain at 6. week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.