AnxietyNCT05811052
The Effect of Suboccipital Release Technique in Individuals With Anxiety
A study testing Suboccipital Release Technique in people with Anxiety and Trapezius Muscle Strain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Trapezius Muscle Strain, Pain
- What is being tested?
- Suboccipital Release Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 28 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over the age of 18
- Agree to participate the study
Who cannot join
- Use psychiatric, analgesic and antispasmodic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anxiety, Trapezius Muscle Strain, Pain
- Being tested
- Suboccipital Release Technique, Sham Suboccipital Release
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suboccipital Release TechniqueOther
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 ReleaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital Release Group | Experimental | Not described Receives: Other: Suboccipital Release Technique |
| Control Group | Sham comparator | Not described Receives: Other: Sham Suboccipital Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Anxiety Level at immediately after treatment
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.
Measured: Change from Baseline anxiety level at Immediately After treatment
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.
Measured: Change from Baseline anxiety level at Immediately After treatment
Hospital Anxiety and Depression Scale
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Change from Baseline anxiety level at Immediately After treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Mar 2022
- Primary completion6 Jul 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezen Tezcan, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811052
- Sponsor's protocol ID
- AIBU-FTR-ST-02
- Status last verified
- May 2024
- First submitted
- 20 Mar 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Suboccipital Release Technique on Trapezius Muscle Activation and Pain in Individuals With Anxiety
- ClinicalTrials.gov ID
- NCT05811052
- Acronym / sponsor ID
- AIBU-FTR-ST-02
- Conditions
- Anxiety, Trapezius Muscle Strain, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboccipital Release Group | Experimental | Other: Suboccipital Release Technique |
| Control Group | Sham comparator | Other: Sham Suboccipital Release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over the age of 18
- Agree to participate the study
Key exclusion criteria (1 listed)
- Use psychiatric, analgesic and antispasmodic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suboccipital Release TechniqueThe 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. | Other | Suboccipital Release Group |
| Sham Suboccipital ReleaseThe 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. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Cranial Rhythm
Time frame: Change from Baseline anxiety level at Immediately After treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital Release Technique in people with Anxiety and Trapezius Muscle Strain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The State- Trait Anxiety Inventory (time frame: Change from Baseline Anxiety Level at immediately after treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.