NCT04817384

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 23, 2021

Last Update Submit

March 25, 2021

Conditions

Keywords

grastonmassagechildrenmusculoskeletal

Outcome Measures

Primary Outcomes (1)

  • 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.

    change from baseline to immediately after the intervention

Secondary Outcomes (3)

  • Pain Threshold measured by Pressure Algometry

    change from baseline to immediately after the intervention

  • Range of motions of neck joint measured by universal goniometer

    change from baseline to immediately after the intervention

  • Satisfaction level from the application measured by VAS

    immediately after the intervention

Study Arms (2)

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.

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.

Other: Graston technique

Interventions

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 massage group

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.

Graston technique group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Esra Mıhçıoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 26, 2021

Study Start

April 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03