NeckNCT04817384
Graston Technique and Classical Massage for Chronic Neck Pain of Children
A study testing Graston technique and Classical Massage in people with Neck and Pain, run by Eastern Mediterranean University.
Trial summary
In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- What is being tested?
- Graston technique and Classical Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Sep 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children who have a chronic neck pain diagnosed by physician.
- The children who have minimum 10 degree limitation in at least one of neck movements.
- The children who have pain in neck region higher than 3 from Wong Baker pain scale.
- The children who state that they have neck pain for at least 3 months
Who cannot join
- The children who have other pain related to neurological or other orthopedic problem apart from neck region.
- The children who have any chronic disease requiring use of medicine like Hypertension and Diabetes Mellitus.
- The children who have open wound in neck region which may affect the interventions.
Trial locations and contacts
No sites are listed yet.
Esra Mıhçıoğlu contact
About this study
Official title: Comparison of Immediate Effects of Graston Technique and Classical Massage in Primary School Children With Chronic Neck Pain
In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.
Read the detailed description
Although there are new physiotherapy interventions for musculoskeletal pain, it is seen that studies about manual techniques are limited in childhood. Graston technique includes a small metallic instrument known as "strigil" and used for therapeutic purposes in ancient Greece and Rome. Another source is based on the traditional Chinese treatment known as "gua sha". Those who found the Graston technique are Dr. Konin, Dr. Greenstein, and Dr. Schrader. The basis of the Graston technique used today was inspired by James Cyriax. When the effects of the Graston technique are investigated, they aim to reduce pain, evaluate and increase soft tissue mobility, and improve range of motion and function. This technique is applied using specially designed curved stainless steel tools. These devices create micro trauma to restore normal elasticity and function in soft tissue. The different structures of the instruments allow to modify the degree of treatment. Small size instruments can be used on smaller anatomical structures and mild symptoms. Larger sized instruments are suitable for large treatment areas and severe conditions. Instruments are applied to the soft tissue at 30-60 degree angles with multi-directional stroking movements. The application time is applied for a maximum of 30 to 60 seconds per tissue site. In addition, whether the problem is acute or chronic is the most important factor that determines the duration of treatment. Total treatment time with instruments is generally minimum 8 minutes. It is applied with a maximum of 20 minutes.
In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.
- Being tested
- Graston technique, Classical Massage
- Keywords
- graston, massage, children, musculoskeletal
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston techniqueOther
For Graston practice, children will be asked to sit with a support forward. Vaseline will be used as an intermediate during the application. Instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. Larger instruments will be used for larger areas and smaller for smaller regions and fibrocytic areas. The frequency of the plastering and friction movements will be applied in 60 repetitions per minute. While the graston technique is applied to individuals; Superficial muscles in the entire dorsal region will be included in the treatment. These muscles, respectively, the levator scapula, trapezius, and erroctor spina muscles were selected. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at.
Classical MassageOther
In the neck massage application, the patient should be prepared, and the clothes in the upper back and neck area should be removed. The position of the patient will be in a sitting position with a pillow in front of him. The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Graston technique group | Experimental | For Graston practice, instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at. Receives: Other: Classical Massage |
| Classical massage group | Experimental | The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes. Receives: Other: Graston technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Pain measured by Wong-Baker Faces Pain Rating Scale
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child will be asked to determine their level of pain according to this scale before and after the intervention.
Measured: change from baseline to immediately after the intervention
Secondary outcomes (3)
Pain Threshold measured by Pressure Algometry
Pressure algometry will be used to measure threshold. The pressure on the painful region is recorded in number (P).
Measured: change from baseline to immediately after the intervention
Range of motions of neck joint measured by universal goniometer
Universal goniometer will be used for neck joint. Flexion, extension, lateral flexion and rotations will be recorded in degrees.
Measured: change from baseline to immediately after the intervention
Satisfaction level from the application measured by VAS
The child will be asked to specify his/her satisfaction from the manual therapy (graston or classical massage) after the practice. The Visual Analogue Scale will be used to show the level. Zero will ne no any satisfaction and Ten will be too much satisfaction. The line starting from zere to ten cm will be given to child and asked to sign how much he/she is satisfied from the intervention.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeckStudies 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
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817384
- Sponsor's protocol ID
- ETK00-2020-0238
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 26 Mar 2021
- 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 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immediate Effects of Graston Technique and Classical Massage in Primary School Children With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04817384
- Acronym / sponsor ID
- ETK00-2020-0238
- Keywords
- graston, massage, children, musculoskeletal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 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 reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.
Detailed description
Although there are new physiotherapy interventions for musculoskeletal pain, it is seen that studies about manual techniques are limited in childhood. Graston technique includes a small metallic instrument known as "strigil" and used for therapeutic purposes in ancient Greece and Rome. Another source is based on the traditional Chinese treatment known as "gua sha". Those who found the Graston technique are Dr. Konin, Dr. Greenstein, and Dr. Schrader. The basis of the Graston technique used today was inspired by James Cyriax. When the effects of the Graston technique are investigated, they aim to reduce pain, evaluate and increase soft tissue mobility, and improve range of motion and function. This technique is applied using specially designed curved stainless steel tools. These devices create micro trauma to restore normal elasticity and function in soft tissue. The different structures of the instruments allow to modify the degree of treatment. Small size instruments can be used on smaller anatomical structures and mild symptoms. Larger sized instruments are suitable for large treatment areas and severe conditions. Instruments are applied to the soft tissue at 30-60 degree angles with multi-directional stroking movements. The application time is applied for a maximum of 30 to 60 seconds per tissue site. In addition, whether the problem is acute or chronic is the most important factor that determines the duration of treatment. Total treatment time with instruments is generally minimum 8 minutes. It is applied with a maximum of 20 minutes.
In reviews about manual therapy in children, mild, low-speed spinal mobilizations are emphasized as a safe treatment technique in infants, children and adolescents and have been used in clinics for years. Practices such as manipulation and manual therapy should adjust the force and speed used by the specialist practitioner in accordance with the age and developmental level of the child. Studies have emphasized that massage is an effective method in the treatment of chronic pain for children and adolescents. Significantly low pain and positive mood have been reported by children after these manual therapy sessions. Accordingly, the aim of the planned study is to compare the effects of graston technique and classical massage in children with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Graston technique group | Experimental | Other: Classical MassageFor Graston practice, instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at. |
| Classical massage group | Experimental | Other: Graston techniqueThe trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The children who have a chronic neck pain diagnosed by physician.
- The children who have minimum 10 degree limitation in at least one of neck movements.
- The children who have pain in neck region higher than 3 from Wong Baker pain scale.
- The children who state that they have neck pain for at least 3 months
Key exclusion criteria (3 listed)
- The children who have other pain related to neurological or other orthopedic problem apart from neck region.
- The children who have any chronic disease requiring use of medicine like Hypertension and Diabetes Mellitus.
- The children who have open wound in neck region which may affect the interventions.
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 |
|---|---|---|
| Graston techniqueFor Graston practice, children will be asked to sit with a support forward. Vaseline will be used as an intermediate during the application. Instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. Larger instruments will be used for larger areas and smaller for smaller regions and fibrocytic areas. The frequency of the plastering and friction movements will be applied in 60 repetitions per minute. While the graston technique is applied to individuals; Superficial muscles in the entire dorsal region will be included in the treatment. These muscles, respectively, the levator scapula, trapezius, and erroctor spina muscles were selected. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at. | Other | Classical massage group |
| Classical MassageIn the neck massage application, the patient should be prepared, and the clothes in the upper back and neck area should be removed. The position of the patient will be in a sitting position with a pillow in front of him. The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes. | Other | Graston technique group |
Primary outcome
Level of Pain measured by Wong-Baker Faces Pain Rating Scale
Time frame: change from baseline to immediately after the intervention
The Wong-Baker Faces Pain Rating Scale is a pain scale that was developed by Donna Wong and Connie Baker. The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". The child will be asked to determine their level of pain according to this scale before and after the intervention.
3 secondary outcomes
Pain Threshold measured by Pressure Algometry
Time frame: change from baseline to immediately after the intervention
Range of motions of neck joint measured by universal goniometer
Time frame: change from baseline to immediately after the intervention
Satisfaction level from the application measured by VAS
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
Esra Mıhçıoğlu contact
Questions about this trial
What is this clinical trial studying?
A study testing Graston technique and Classical Massage in people with Neck and Pain, run by Eastern Mediterranean University.
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 4 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: status not confirmed, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZEHRA G TOPCU (+903926303067 ext. 2496, zehra.guchan@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Pain measured by Wong-Baker Faces Pain Rating Scale (time frame: change from baseline to immediately after the intervention). 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 26 Mar 2021.