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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05811052
Other study ID # AIBU-FTR-ST-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date February 28, 2023

Study information

Verified date May 2024
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the immediate effect of the suboccipital release technique on trapezius muscle pain threshold, muscle activation, and anxiety level in individuals with anxiety.Thirty-six people with anxiety symptoms were included in the study. These people were divided into two groups, 18 control group and 18 treatment group. Upper trapezius muscle pain threshold, muscle activation and anxiety levels were evaluated. The experimental group received a single session of suboccipital release technique. The control group received a single session of sham suboccipital release. The evaluations were performed before and immediately after the treatment.The suboccipital release technique can increase the trapezius muscle upper part pain threshold and concentric muscle activation immediately after the application in individuals with anxiety.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 28, 2023
Est. primary completion date July 6, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Being over the age of 18 - Agree to participate the study Exclusion Criteria: - Use psychiatric, analgesic and antispasmodic drugs

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Suboccipital Release Technique
The suboccipital release technique was applied to the participants in the experimental group by an experienced practitioner who had received osteopathy training. The individual lay in the supine position, and the practitioner applied the relaxation technique by placing his hands on the patient's nape-atlantooccipital joint. The application was continued until the relaxation of the muscles under the hand of the practitioner.
Sham Suboccipital Release
The participants in the control group were given a sham application by touching the hands of the therapist on the nape of the neck and waiting for a while.

Locations

Country Name City State
Turkey sezen Tezcan Bolu Merkez

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The State- Trait Anxiety Inventory The State Anxiety Scale includes questions that require the respondent to answer by taking into account his/her current feelings, while the Trait Anxiety Scale includes questions that evaluate how the respondent feels in general. It is a 4-point Likert scale. The total score obtained from both scales is minimum 20 and maximum 80. A high score indicates a high level of anxiety and a low score indicates a low level of anxiety. Change from Baseline Anxiety Level at immediately after treatment
Primary Pain Assessment Pain threshold was evaluated with a manual algometer device. The midpoint of the upper trapezius muscle and the tender point with the highest pain were marked. Change from Baseline anxiety level at Immediately After treatment
Primary Surface Electromyography Measurements Maximum Voluntary Concentration (MVC) value was then measured. For the MVC value, individuals were asked to push their shoulders up (in the upward direction) against a manual resistance for 5 seconds. The measurement was repeated 3 times and 2 rests were taken after each measurement. The highest of the values was used for normalization. Afterwards, the subjects were asked to perform active shoulder elevation (concentric activity) for 3 seconds and return to neutral position for 3 seconds with the metronome. For normalization, % MVC and function % MVC values were calculated using the values recorded for all recordings. Change from Baseline anxiety level at Immediately After treatment
Primary Hospital Anxiety and Depression Scale Toplam 14 maddeden olusan (/ Anksiyete ve 7 Depresyon sorusu). 4'lü Likert tipinde bir ölçektir. 0-3 arasinda bir puanlama yapilirç 0-1 puan hasta olmayan, 2 puan sinirda hasta, 2-3 puan agir hasta olarak degerlendirilir. Baseline
Secondary Cranial Rhythm Individuals were placed on the treatment bed in the supine position. The therapist touched the individual's skull and recorded the number of cycles received in one minute. Change from Baseline anxiety level at Immediately After treatment
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