Cervical PainNCT04765670
Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application in Individuals With Chronic Neck Pain.
A study testing Instrument Assisted Soft Tissue Mobilization and Kinesiotape Application in people with Cervical Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Chronic neck pain causes errors in joint position sense. There are studies in the literature suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications improve the joint position sense. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Pain
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization and Kinesiotape Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 5 Jul 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being diagnosed with chronic neck pain
- Being in the age range of 18-45
Who cannot join
- Those with acute injury or infection,
- Those with open wounds,
- Osteoporosis,
- Hematoma,
- Those with acute cardiac, liver and kidney problems,
- Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
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- Those with circulation problems,
- Those with peripheral vascular disease,
- Epilepsy
- Identified as a history of surgery in the cervical region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application on Pain and Joint Position Sense in Individuals With Chronic Neck Pain.
Chronic neck pain causes errors in joint position sense. There are studies in the literature suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications improve the joint position sense. There is no study examining these applications acutely on joint position sense and pain in the cervical region. As a result of our study, we will compare the effects of single-session instrument-assisted soft tissue mobilization and Kinesiotape application on pain and joint position sense.
Read the detailed description
The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-45 with chronic neck pain will be included in the study after obtaining their informed consent.
Participants will be randomly divided into two groups: Instrument assisted soft tissue mobilization and Kinesiotape Applications.
In the instrument-assisted soft tissue mobilization group, the trapezius and sternocleidomastoideus muscles will be applied in a single session for 90 seconds. Kinesiotape application will be applied to the trapezius and sternocleidomastoideus muscles in one session.
Pain will be evaluated with Visual Analog Scale and joint position sense will be evaluated with Cervical Range of Motion device before and after application.
- Conditions
- Cervical Pain
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Kinesiotape Application
- Keywords
- Chronic cervical pain, Instrument Assisted Soft Tissue Mobilization, Kinesiotape, Joint position sense
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Kinesiotape ApplicationOther
Bilateral Kinesiotape application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | The instruments will be applied to the soft tissue at 30º-60º angles, with multi-directional "stroking" movements. Instrument Assisted Soft Tissue Mobilization will be applied to the trapezius and sternocleidomastoideus muscles of the participants for 90 seconds. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
| Kinesiotape Application | Experimental | The application will be made from the insertion of the upper trapezoidal muscle to its origo . During taping, the patient will be allowed to sit in an upright position in a chair with a back, with the scapula fixed, without supporting the arms. Before taping, the patient will be positioned with the shoulder in adduction and the head in lateral flexion towards the contralateral side. The patient will be asked to perform shoulder abduction against resistance, and the insertion area of the upper trapezius fibers will be palpated. The initial 2-3 cm part of the band will be glued to the lateral of the acromion without stretching, after full (100%) stretching is applied to the 2-3 cm part of the band from the insertion area of the upper trapezoid fibers, the patient's head is rotated to the affected side and the arm part of the band is stretched along the muscle fibers. it will be glued up to the hairline without doing it. Receives: Other: Kinesiotape Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cervical Pain at 2 minutes
Pain will be evaluated with Visual Analog Scale.
Measured: Baseline and 2 minutes after intervention
Change from Baseline Joint Position Sense at 2 minutes
Joint Position Sense will be evaluated Cervical Range of Motion Device
Measured: Baseline and 2 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Mar 2021
- Primary completion1 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hasan Gerçek, Principal investigator, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765670
- Sponsor's protocol ID
- KaratayUH2
- Status last verified
- Feb 2021
- First submitted
- 16 Feb 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application on Pain and Joint Position Sense in Individuals With Chronic Neck Pain.
- ClinicalTrials.gov ID
- NCT04765670
- Acronym / sponsor ID
- KaratayUH2
- Conditions
- Cervical Pain
- Keywords
- Chronic cervical pain, Instrument Assisted Soft Tissue Mobilization, Kinesiotape, Joint position sense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 21 Feb 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.
Chronic neck pain causes errors in joint position sense. There are studies in the literature suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications improve the joint position sense. There is no study examining these applications acutely on joint position sense and pain in the cervical region. As a result of our study, we will compare the effects of single-session instrument-assisted soft tissue mobilization and Kinesiotape application on pain and joint position sense.
Detailed description
The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-45 with chronic neck pain will be included in the study after obtaining their informed consent.
Participants will be randomly divided into two groups: Instrument assisted soft tissue mobilization and Kinesiotape Applications.
In the instrument-assisted soft tissue mobilization group, the trapezius and sternocleidomastoideus muscles will be applied in a single session for 90 seconds. Kinesiotape application will be applied to the trapezius and sternocleidomastoideus muscles in one session.
Pain will be evaluated with Visual Analog Scale and joint position sense will be evaluated with Cervical Range of Motion device before and after application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Other: Instrument Assisted Soft Tissue MobilizationThe instruments will be applied to the soft tissue at 30º-60º angles, with multi-directional "stroking" movements. Instrument Assisted Soft Tissue Mobilization will be applied to the trapezius and sternocleidomastoideus muscles of the participants for 90 seconds. |
| Kinesiotape Application | Experimental | Other: Kinesiotape ApplicationThe application will be made from the insertion of the upper trapezoidal muscle to its origo . During taping, the patient will be allowed to sit in an upright position in a chair with a back, with the scapula fixed, without supporting the arms. Before taping, the patient will be positioned with the shoulder in adduction and the head in lateral flexion towards the contralateral side. The patient will be asked to perform shoulder abduction against resistance, and the insertion area of the upper trapezius fibers will be palpated. The initial 2-3 cm part of the band will be glued to the lateral of the acromion without stretching, after full (100%) stretching is applied to the 2-3 cm part of the band from the insertion area of the upper trapezoid fibers, the patient's head is rotated to the affected side and the arm part of the band is stretched along the muscle fibers. it will be glued up to the hairline without doing it. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Being diagnosed with chronic neck pain
- Being in the age range of 18-45
Key exclusion criteria (10 listed)
- Those with acute injury or infection,
- Those with open wounds,
- Osteoporosis,
- Hematoma,
- Those with acute cardiac, liver and kidney problems,
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationBilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles. | Other | Instrument Assisted Soft Tissue Mobilization |
| Kinesiotape ApplicationBilateral Kinesiotape application will be applied in a single session to the trapezius and sternocleideomastoideus muscles. | Other | Kinesiotape Application |
Primary outcome
Change from Baseline Cervical Pain at 2 minutes
Time frame: Baseline and 2 minutes after intervention
Pain will be evaluated with Visual Analog Scale.
Change from Baseline Joint Position Sense at 2 minutes
Time frame: Baseline and 2 minutes after intervention
Joint Position Sense will be evaluated Cervical Range of Motion Device
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 3 Aug 2021.
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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.
Hasan Gerçek principal investigator
KTO Karatay 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 Instrument Assisted Soft Tissue Mobilization and Kinesiotape Application in people with Cervical 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 2 inclusion and 10 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 3 Aug 2021. 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 at 2 minutes (time frame: Baseline and 2 minutes after intervention). The study lists 2 primary outcomes in all. 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 3 Aug 2021.