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The Effect of Suboccipital Release Technique in Individuals With Anxiety

Primary Purpose

Anxiety, Trapezius Muscle Strain, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Suboccipital Release Technique
Sham Suboccipital Release
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being over the age of 18 Agree to participate the study Exclusion Criteria: Use psychiatric, analgesic and antispasmodic drugs

Sites / Locations

  • sezen Tezcan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Suboccipital Release Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

The State- Trait Anxiety Inventory
The State Anxiety Scale consists of questions that require the person to answer by considering their feelings about the moment. On the trait anxiety scale, there are questions that evaluate how the person generally feels. A 4-point Likert-type scale is used in scale items. The total score obtained from both scales is at least 20 and at most 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety
Pain Assessment
The pain threshold was evaluated with the algometer device by marking the middle point of the upper trapezius muscle and the sensitive point where the pain is the most.
Surface Electromyography Measurements
The Maximum Voluntary Concentration (MVC) value was then measured. For the MVC value, individuals were asked to push the shoulders up (in the direction of elevation) for 5 seconds against a manual resistance. The measurement was repeated 3 times and the highest measured value was used for MVC normalization. In order not to create muscle fatigue, 2 min rest intervals were given between measurements. Finally, the individuals were asked to actively raise their shoulders (concentric activity) for 3 seconds using a metronome, and to actively bring their shoulders to the neutral position from this position for 3 seconds. During recording, artifact formation was checked on the computer screen, and when artifact occurred, recording was stopped and repeated. For normalization, resting % MVC and function % MVC values, which show the workload of the muscle, were calculated using the data obtained after the rest, function and MVC recordings
Hospital Anxiety and Depression Scale
The scale consists of a total of 14 items, 7 of which evaluate symptoms of anxiety and 7 of which evaluate symptoms of depression. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as non-patient, 2 as borderline patients, and 2-3 as severely ill

Secondary Outcome Measures

Cranial Rhythm
Cranial rhythm evaluation, which is an osteopathic measurement technique, was performed by placing the individuals on the treatment bed in the supine position and touching the skull. The number of cycles taken in 1 minute was noted.

Full Information

First Posted
March 20, 2023
Last Updated
March 31, 2023
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05811052
Brief Title
The Effect of Suboccipital Release Technique in Individuals With Anxiety
Official Title
The Effect of Suboccipital Release Technique on Trapezius Muscle Activation and Pain in Individuals With Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study aims to determine the immediate effect of the suboccipital release technique on the trapezius muscle pain threshold, muscle activation, and anxiety level in individuals with anxiety.Thirty-six people with symptoms of anxiety and depression, 18 in the control group and 18 in the treatment group, were included in the study. Individuals' anxiety levels, upper trapezius muscle pain threshold, and muscle activation were evaluated. The State-Trait Anxiety Inventory (STAI) was used to determine the anxiety level of the individuals, the algometer device was used to evaluate the pain threshold, and the surface electromyography (sEMG) device was used to evaluate muscle activation. While a single-session suboccipital release technique was applied to the experimental group; The control group was given a sham suboccipital release. Participants were not informed about which group they belonged to. Evaluation parameters were repeated immediately after the application.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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Trapezius Muscle Strain, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suboccipital Release Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Suboccipital Release Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Suboccipital Release
Intervention Description
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.
Primary Outcome Measure Information:
Title
The State- Trait Anxiety Inventory
Description
The State Anxiety Scale consists of questions that require the person to answer by considering their feelings about the moment. On the trait anxiety scale, there are questions that evaluate how the person generally feels. A 4-point Likert-type scale is used in scale items. The total score obtained from both scales is at least 20 and at most 80. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety
Time Frame
Change from Baseline Anxiety Level at immediately after treatment
Title
Pain Assessment
Description
The pain threshold was evaluated with the algometer device by marking the middle point of the upper trapezius muscle and the sensitive point where the pain is the most.
Time Frame
Change from Baseline anxiety level at Immediately After treatment
Title
Surface Electromyography Measurements
Description
The Maximum Voluntary Concentration (MVC) value was then measured. For the MVC value, individuals were asked to push the shoulders up (in the direction of elevation) for 5 seconds against a manual resistance. The measurement was repeated 3 times and the highest measured value was used for MVC normalization. In order not to create muscle fatigue, 2 min rest intervals were given between measurements. Finally, the individuals were asked to actively raise their shoulders (concentric activity) for 3 seconds using a metronome, and to actively bring their shoulders to the neutral position from this position for 3 seconds. During recording, artifact formation was checked on the computer screen, and when artifact occurred, recording was stopped and repeated. For normalization, resting % MVC and function % MVC values, which show the workload of the muscle, were calculated using the data obtained after the rest, function and MVC recordings
Time Frame
Change from Baseline anxiety level at Immediately After treatment
Title
Hospital Anxiety and Depression Scale
Description
The scale consists of a total of 14 items, 7 of which evaluate symptoms of anxiety and 7 of which evaluate symptoms of depression. The items in the scale are evaluated with a 4-point Likert scale and are based on a scoring system between 0-3. According to the scoring, 0-1 is considered as non-patient, 2 as borderline patients, and 2-3 as severely ill
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Cranial Rhythm
Description
Cranial rhythm evaluation, which is an osteopathic measurement technique, was performed by placing the individuals on the treatment bed in the supine position and touching the skull. The number of cycles taken in 1 minute was noted.
Time Frame
Change from Baseline anxiety level at Immediately After treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being over the age of 18 Agree to participate the study Exclusion Criteria: Use psychiatric, analgesic and antispasmodic drugs
Facility Information:
Facility Name
sezen Tezcan
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Suboccipital Release Technique in Individuals With Anxiety

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