Chronic Neck PainNCT05683288
Short and Long Time Effects of IASTM and Myofascial Release Techniques in Chronic Neck Pain
A study testing IASTM, Myofascial Release and 250W infrared application in people with Chronic Neck Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- IASTM, Myofascial Release and 250W infrared application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Dec 2022to 22 Feb 2023
- 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 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- having a diagnosis of chronic neck pain,
- To have given at least 3 values to the pain with the Numerical Pain Scale
- having bilateral muscle spasms in the cervical region
Who cannot join
- those who are taking any analgesic medication,
- those with acute injury or infection,
- those with open wounds,
- osteoporosis,
- fracture,
- hematoma,
Show all 14Show fewer
- those with acute cardiac, liver and kidney problems,
- those with connective tissue disease,
- rheumatoid arthritis, osteoarthritis,
- cancer,
- those with circulation problems,
- those with peripheral vascular disease,
- epilepsy,
- history of surgery in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Instrument Assisted Soft Tissue Mobilization and Myofascial Release Techniques in Individuals With Chronic Neck Pain
The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.
Read the detailed description
Participants will be randomly assigned to IASTM, myofascial release and control groups. In addition to conventional treatment, IASTM and myofascial release groups will be treated twice a week for 4 weeks. Conventional treatment will be applied to the control group for 4 weeks.
- Conditions
- Chronic Neck Pain
- Being tested
- IASTM, Myofascial Release, 250W infrared application, TENS, Home exercise
- Keywords
- Chronic Neck Pain, Disability, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASTMOther
IASTM will be applied to the upper trapezius and sternocleidomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute.
Myofascial ReleaseOther
Basic movements will be performed for 3 minutes in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions.
250W infrared applicationOther
For 15 minutes, 250W infrared application will be applied on the cervical region from a distance of 50 cm
TENSDevice
TENS will be applied for 20 minutes at 80Hz frequency, with a current transit time of 150ms.
Home exerciseOther
Cervical strengthening and stretching exercises five days a week will given
| Study group | Role | What they receive |
|---|---|---|
| IASTM | Experimental | EYYDM will be applied to the upper trapezius and sternocleideomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute. The instruments will be applied to the soft tissue at 30º-60º angles with multidirectional strokes ("stroking") movements. Receives: Other: IASTM |
| Myofascial Release | Experimental | Basic movements will be used in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions within the scope of myofascial release application. The application will take 3 minutes for each region. Receives: Other: Myofascial Release |
| Control | Experimental | It will include 250W infrared application on the cervical region from 50cm away for 15 minutes and TENS application for 20 minutes at 80Hz frequency with 150ms current transit time, home exercise program. Receives: Other: 250W infrared application; Device: TENS; Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cervical Pain assessed by Numeric Pain Scale.
Pain will be evaluated with a 10-point Likert Numerical Pain Scale. 0 means no pain, 10 means unbearable pain.
Measured: Baseline, 4 weeks
Secondary outcomes (1)
Change from Baseline Cervical Disability assessed by Neck Disability Index
Cervical Disability will be evaluated with Neck Disability Index
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start28 Dec 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683288
- Sponsor's protocol ID
- KaratayUH7
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 18 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Instrument Assisted Soft Tissue Mobilization and Myofascial Release Techniques in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05683288
- Acronym / sponsor ID
- KaratayUH7
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic Neck Pain, Disability, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 13 Jan 2023 (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.
The aim of this study is to determine whether EYYDM and myofascial applications have short and long-term effects on pain and disability in individuals diagnosed with chronic neck pain.
Detailed description
Participants will be randomly assigned to IASTM, myofascial release and control groups. In addition to conventional treatment, IASTM and myofascial release groups will be treated twice a week for 4 weeks. Conventional treatment will be applied to the control group for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IASTM | Experimental | Other: IASTMEYYDM will be applied to the upper trapezius and sternocleideomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute. The instruments will be applied to the soft tissue at 30º-60º angles with multidirectional strokes ("stroking") movements. |
| Myofascial Release | Experimental | Other: Myofascial ReleaseBasic movements will be used in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions within the scope of myofascial release application. The application will take 3 minutes for each region. |
| Control | Experimental | Other: 250W infrared application, Device: TENS, Other: Home exerciseIt will include 250W infrared application on the cervical region from 50cm away for 15 minutes and TENS application for 20 minutes at 80Hz frequency with 150ms current transit time, home exercise program. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- having a diagnosis of chronic neck pain,
- To have given at least 3 values to the pain with the Numerical Pain Scale
- having bilateral muscle spasms in the cervical region
Key exclusion criteria (14 listed)
- those who are taking any analgesic medication,
- those with acute injury or infection,
- those with open wounds,
- osteoporosis,
- fracture,
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 |
|---|---|---|
| IASTMIASTM will be applied to the upper trapezius and sternocleidomastoid muscles of the participants for 90 seconds, with a frequency of 60 beats per minute. | Other | IASTM |
| Myofascial ReleaseBasic movements will be performed for 3 minutes in the rectus capitis, sternocleidomastoideus, hyoid region and upper trapezius regions. | Other | Myofascial Release |
| 250W infrared applicationFor 15 minutes, 250W infrared application will be applied on the cervical region from a distance of 50 cm | Other | Control |
| TENSTENS will be applied for 20 minutes at 80Hz frequency, with a current transit time of 150ms. | Device | Control |
| Home exerciseCervical strengthening and stretching exercises five days a week will given | Other | Control |
Primary outcome
Change from Baseline Cervical Pain assessed by Numeric Pain Scale.
Time frame: Baseline, 4 weeks
Pain will be evaluated with a 10-point Likert Numerical Pain Scale. 0 means no pain, 10 means unbearable pain.
1 secondary outcome
Change from Baseline Cervical Disability assessed by Neck Disability Index
Time frame: Baseline, 4 weeks
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 18 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASTM, Myofascial Release and 250W infrared application in people with Chronic Neck Pain, run by KTO Karatay University 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 14 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 18 Jul 2024. 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?
Change from Baseline Cervical Pain assessed by Numeric Pain Scale. (time frame: Baseline, 4 weeks). 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 18 Jul 2024.