The Effect of Suboccipital Release Technique in Individuals With Anxiety

Pain Clinical Trial

Official title:

The Effect of Suboccipital Release Technique on Trapezius Muscle Activation and Pain in Individuals With Anxiety

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

• Verified date: March 2023
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Trapezius Muscle Strain

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 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	Change from Baseline Anxiety Level at immediately after treatment
Primary	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.	Change from Baseline anxiety level at Immediately After treatment
Primary	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	Change from Baseline anxiety level at Immediately After treatment
Primary	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	Baseline
Secondary	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.	Change from Baseline anxiety level at Immediately After treatment