Neck PainNCT04968769
Comparison of Ischemic Compression Therapy and Kinesiotaping in Chronic Neck Pain
A study testing ischemic compression, kinesio taping and exercise in people with Neck Pain, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The purpose of this study was to compare the effects of ischemic compression (IC) and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and joint range of motion on the upper trapezius muscle of individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- ischemic compression, kinesio taping and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 8 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 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A score ar least 3 and above 3 on the Visual analogue scale
- Presence of palpable taut band and at least one trigger point on the taut band
- Presence of referred pain with palpation of the trigger point
Who cannot join
- Analgesic use within the previous 24hours
- History of cervical surgery
- Receiving myofascial pain treatment within the previous month of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ischemic Compression Therapy and Kinesiotaping on Blood Flow, Tissue Stiffness, Pain and Range of Motion in Chronic Neck Pain
Objective: The purpose of this study was to compare the effects of ischemic compression (IC) and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and joint range of motion on the upper trapezius muscle of individuals with chronic neck pain.
Methods: In this study 22 individuals between the ages of 20-35 were randomly assigned to 3 groups: Group1, which received IC; Group2, received KT; Group3 (control) received exercise, for 2 days and 4 weeks. Pain was measured with VAS, pain threshold with J-Tech Algometer, range of motion with BASELINE Digital Inclinometer, ultrasonographic measurements for blood flow, tissue stiffness and tissue thickness using Acuson S3000. All measurements were performed twice; before and after treatment.
- Conditions
- Neck Pain
- Being tested
- ischemic compression, kinesio taping, exercise
- Keywords
- Trapezius muscle, trigger point, ultrasonographic imaging, blood flow, chronic pain
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic compressionOther
manual therapy
kinesio tapingOther
elastic therapeutic taping
exerciseOther
posture exercises
| Study group | Role | What they receive |
|---|---|---|
| ischemic compression and exercise | Experimental | Individuals were positioned in a comfortable position in a chair with back support. By palpating the UT muscle, first the taut band and then the active TP on the muscle were determined. Before starting the treatment, , a statement was made to the individual that "you will soon feel a high level of pain with pressure, and at the same time, you may feel pain, tingling, pricking in additional areas (head-neck-shoulder-arm), after a while the pain will decrease and disappear. In this process, try to stay as steady as possible and breathe regularly and calmly.'' The highest level of pressure that the patient could tolerate was applied to the determined TP with the thumb. Pressure time will be in the range of at least 10-20 seconds and at most 60 seconds; It was terminated after the therapist felt complete relaxation in the tissue under his thumb or after the patient received the return of "pain completely disappeared" Receives: Other: ischemic compression; Other: exercise |
| kinesio taping and exercise | Experimental | While performing KT, the individual was seated in a comfortable and upright position in a chair with back support. The subject was asked to bring his hand to his back in internal rotation of the shoulder of the taped side and to bring his head to the contralateral lateral flexion and contralateral rotation so that the UT muscle was in a tense position. KT was applied using 'muscle inhibition technique' to ensure correct contraction of the muscle with muscle length/tension optimization, to target the reduction of excessive muscle tension, and to increase circulation with the effects of the tape on the skin. In this technique, to inhibit the muscle, the tape direction is from the muscle insertion to the origin. KT was performed 5 cm below the acromion to the protuberantia occipitalis with 10% tension Receives: Other: kinesio taping; Other: exercise |
| exercise | Active comparator | In order for all the exercises to be done correctly and not to cause any pain, the individuals were asked to perform the movements in front of the mirror. Posture exercises given the individuals for scapular retraction. During the posture exercises individual was positioned in a chair without back support. By counting 5 it was requested to do 10 repetitions of each exercise. For the UT muscle stretching, individuals were asked to hold their right ear with their left hand over their head while sitting on a back-supported chair with their hips and back fully resting on the chair, and to bring their left ear closer to their left shoulder with the help of their hand and count to 20 from the outside. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Visual Analogue Scale: Individuals were asked to mark the intensity of neck pain on the scale, defining the visual analog scale as 0 "absence of pain-no pain" and 10 "unbearable-worst pain". The distance between the sign of the individual and the 0 point was measured and recorded
Measured: 4 weeks
pain threshold
Individuals were asked to sit in a comfortable position in a chair with back support. Before starting the measurement, a statement was made to the individual that "when the pressure sensation turns into pain, give a stop warning". The measurement was repeated 3 times and the average value was recorded. A 30-second interval was taken between measurements to prevent temporal summation. Measurements were taken over the UT muscle of the dominant extremity with the J-TECH USA Commander Algometer device
Measured: 4 weeks
range of motion
For ROM measurements individuals were asked to sit on a chair with back support with hands on thighs, shoulders free, hips and knees 90 flexed. For neck flexion and extension movements, the inclinometer was placed on the head of the individual in the sagittal plane, and for the right and left lateral flexion movements, the inclinometer was placed in the frontal plane. For neck rotation measurements, the individual was placed in a supine and relaxed position. The inclinometer was placed on the forehead of the head in the transverse plane. For each measurement, the individual was asked to actively perform the movement to be measured, and the average value was recorded for each parameter by repeating it 3 times. Before each measurement, the inclinometer was restarted after it was positioned over the individual's head. Measurements were made with the BASELİNE Digital Inclinometer device
Measured: 4 weeks
Ultrasonographic Measurements
Ultrasonographic measurements Using a 9L4 MHz (Megahertz) linear transducer (Acuson S2000, Siemens Healthcare, Erlangen, Germany) with sufficient amount of gel, the upper fibers of the dominant tar
trapezius muscle were aligned longitudinally to the muscle fibers inside the transducer UT muscle with a dorsal approach at the mid-clavicular line level. The thickness of the UT muscle, B mode, peak systolic velocity (PV-cm/s) data from the transverse cervical artery, color Doppler ultrasound (RDUS) and the UT muscle fibers of the muscle again in quantitative ARFI mode (Virtual Touch Quantification®, VTq) for tissue stiffness assessment. Mean VTq values were calculated by taking VTq (m/sec) measurements 10 times.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 May 2021
- Primary completion8 Jul 2021
- Study completion8 Jul 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
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihan Ozunlu Pekyavas, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968769
- Sponsor's protocol ID
- KA 21/19
- Status last verified
- Jul 2021
- First submitted
- 9 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ischemic Compression Therapy and Kinesiotaping on Blood Flow, Tissue Stiffness, Pain and Range of Motion in Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04968769
- Acronym / sponsor ID
- KA 21/19
- Conditions
- Neck Pain
- Keywords
- Trapezius muscle, trigger point, ultrasonographic imaging, blood flow, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 20 Jul 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.
Objective: The purpose of this study was to compare the effects of ischemic compression (IC) and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and joint range of motion on the upper trapezius muscle of individuals with chronic neck pain.
Methods: In this study 22 individuals between the ages of 20-35 were randomly assigned to 3 groups: Group1, which received IC; Group2, received KT; Group3 (control) received exercise, for 2 days and 4 weeks. Pain was measured with VAS, pain threshold with J-Tech Algometer, range of motion with BASELINE Digital Inclinometer, ultrasonographic measurements for blood flow, tissue stiffness and tissue thickness using Acuson S3000. All measurements were performed twice; before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| ischemic compression and exercise | Experimental | Other: ischemic compression, Other: exerciseIndividuals were positioned in a comfortable position in a chair with back support. By palpating the UT muscle, first the taut band and then the active TP on the muscle were determined. Before starting the treatment, , a statement was made to the individual that "you will soon feel a high level of pain with pressure, and at the same time, you may feel pain, tingling, pricking in additional areas (head-neck-shoulder-arm), after a while the pain will decrease and disappear. In this process, try to stay as steady as possible and breathe regularly and calmly.'' The highest level of pressure that the patient could tolerate was applied to the determined TP with the thumb. Pressure time will be in the range of at least 10-20 seconds and at most 60 seconds; It was terminated after the therapist felt complete relaxation in the tissue under his thumb or after the patient received the return of "pain completely disappeared" |
| kinesio taping and exercise | Experimental | Other: kinesio taping, Other: exerciseWhile performing KT, the individual was seated in a comfortable and upright position in a chair with back support. The subject was asked to bring his hand to his back in internal rotation of the shoulder of the taped side and to bring his head to the contralateral lateral flexion and contralateral rotation so that the UT muscle was in a tense position. KT was applied using 'muscle inhibition technique' to ensure correct contraction of the muscle with muscle length/tension optimization, to target the reduction of excessive muscle tension, and to increase circulation with the effects of the tape on the skin. In this technique, to inhibit the muscle, the tape direction is from the muscle insertion to the origin. KT was performed 5 cm below the acromion to the protuberantia occipitalis with 10% tension |
| exercise | Active comparator | Other: exerciseIn order for all the exercises to be done correctly and not to cause any pain, the individuals were asked to perform the movements in front of the mirror. Posture exercises given the individuals for scapular retraction. During the posture exercises individual was positioned in a chair without back support. By counting 5 it was requested to do 10 repetitions of each exercise. For the UT muscle stretching, individuals were asked to hold their right ear with their left hand over their head while sitting on a back-supported chair with their hips and back fully resting on the chair, and to bring their left ear closer to their left shoulder with the help of their hand and count to 20 from the outside. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A score ar least 3 and above 3 on the Visual analogue scale
- Presence of palpable taut band and at least one trigger point on the taut band
- Presence of referred pain with palpation of the trigger point
Key exclusion criteria (3 listed)
- Analgesic use within the previous 24hours
- History of cervical surgery
- Receiving myofascial pain treatment within the previous month of the study
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 |
|---|---|---|
| ischemic compressionmanual therapy | Other | ischemic compression and exercise |
| kinesio tapingelastic therapeutic taping | Other | kinesio taping and exercise |
| exerciseposture exercises | Other | exercise, ischemic compression and exercise, kinesio taping and exercise |
Primary outcome
pain intensity
Time frame: 4 weeks
Visual Analogue Scale: Individuals were asked to mark the intensity of neck pain on the scale, defining the visual analog scale as 0 "absence of pain-no pain" and 10 "unbearable-worst pain". The distance between the sign of the individual and the 0 point was measured and recorded
pain threshold
Time frame: 4 weeks
Individuals were asked to sit in a comfortable position in a chair with back support. Before starting the measurement, a statement was made to the individual that "when the pressure sensation turns into pain, give a stop warning". The measurement was repeated 3 times and the average value was recorded. A 30-second interval was taken between measurements to prevent temporal summation. Measurements were taken over the UT muscle of the dominant extremity with the J-TECH USA Commander Algometer device
range of motion
Time frame: 4 weeks
For ROM measurements individuals were asked to sit on a chair with back support with hands on thighs, shoulders free, hips and knees 90 flexed. For neck flexion and extension movements, the inclinometer was placed on the head of the individual in the sagittal plane, and for the right and left lateral flexion movements, the inclinometer was placed in the frontal plane. For neck rotation measurements, the individual was placed in a supine and relaxed position. The inclinometer was placed on the forehead of the head in the transverse plane. For each measurement, the individual was asked to actively perform the movement to be measured, and the average value was recorded for each parameter by repeating it 3 times. Before each measurement, the inclinometer was restarted after it was positioned over the individual's head. Measurements were made with the BASELİNE Digital Inclinometer device
Ultrasonographic Measurements
Time frame: 4 weeks
Ultrasonographic measurements Using a 9L4 MHz (Megahertz) linear transducer (Acuson S2000, Siemens Healthcare, Erlangen, Germany) with sufficient amount of gel, the upper fibers of the dominant tar trapezius muscle were aligned longitudinally to the muscle fibers inside the transducer UT muscle with a dorsal approach at the mid-clavicular line level. The thickness of the UT muscle, B mode, peak systolic velocity (PV-cm/s) data from the transverse cervical artery, color Doppler ultrasound (RDUS) and the UT muscle fibers of the muscle again in quantitative ARFI mode (Virtual Touch Quantification®, VTq) for tissue stiffness assessment. Mean VTq values were calculated by taking VTq (m/sec) measurements 10 times.
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 20 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 ischemic compression, kinesio taping and exercise in people with Neck Pain, run by Baskent 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 3 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 20 Jul 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?
pain intensity (time frame: 4 weeks). The study lists 4 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 20 Jul 2021.