- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05811052
The Effect of Suboccipital Release Technique in Individuals With Anxiety
May 9, 2024 updated by: Sezen Tezcan, Abant Izzet Baysal University
The Effect of Suboccipital Release Technique on Trapezius Muscle Activation and Pain in Individuals With Anxiety
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Bolu, Merkez, Turkey, 14200
- sezen Tezcan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being over the age of 18
- Agree to participate the study
Exclusion Criteria:
- Use psychiatric, analgesic and antispasmodic drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: Control Group
|
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.
|
|
Experimental: Suboccipital Release Group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The State- Trait Anxiety Inventory
Time Frame: Change from Baseline Anxiety Level at immediately after treatment
|
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
|
|
Pain Assessment
Time Frame: Change from Baseline anxiety level at Immediately After treatment
|
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
|
|
Surface Electromyography Measurements
Time Frame: Change from Baseline anxiety level at Immediately After treatment
|
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
|
|
Hospital Anxiety and Depression Scale
Time Frame: Baseline
|
Toplam 14 maddeden oluşan (/ Anksiyete ve 7 Depresyon sorusu).
4'lü Likert tipinde bir ölçektir.
0-3 arasında bir puanlama yapılırç 0-1 puan hasta olmayan, 2 puan sınırda hasta, 2-3 puan ağır hasta olarak değerlendirilir.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cranial Rhythm
Time Frame: Change from Baseline anxiety level at Immediately After treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
July 6, 2022
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
March 20, 2023
First Submitted That Met QC Criteria
March 31, 2023
First Posted (Actual)
April 13, 2023
Study Record Updates
Last Update Posted (Actual)
May 13, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-ST-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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