NCT05811052

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

March 20, 2023

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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.

    Baseline

Secondary Outcomes (1)

  • Cranial Rhythm

    Change from Baseline anxiety level at Immediately After treatment

Study Arms (2)

Suboccipital Release Group

EXPERIMENTAL
Other: Suboccipital Release Technique

Control Group

SHAM COMPARATOR
Other: Sham Suboccipital Release

Interventions

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.

Suboccipital Release 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.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over the age of 18
  • Agree to participate the study

You may not qualify if:

  • Use psychiatric, analgesic and antispasmodic drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

sezen Tezcan

Bolu, Merkez, 14200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

March 20, 2023

First Posted

April 13, 2023

Study Start

March 1, 2022

Primary Completion

July 6, 2022

Study Completion

February 28, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations