- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761391
Effects of Suboccipital Release on Sensorial and Functional Parameters
Immediate Effects of Suboccipital Myofascial Release on Pain Pressure Threshold, Range of Motion, Balance, and Proprioception
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey
- Bezmialem Vakif University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Volunteers willing to participate in the study.
Exclusion Criteria:
Diagnosed with an upper extremity musculoskeletal system disease. Experiencing chronic headaches or migraine complaints. Presence of any pathology causing sensory or balance impairments. Diagnosed with a pathology in the cervical regio
Study Plan
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 |
|---|---|
|
Experimental: Suboccipital Myofascial Release
The application will be done in the supine position.
The therapist will sit on the stool at the head of the stretcher with his/her forearm in contact with the stretcher.
After palpating the occiput condyles with his/her fingers, the therapist will place his/her fingers in the slightly concave area between the occiput and the spinous process of the second cervical vertebra.
The therapist will lift the participant's head a little by bending the metacarpophalangeal joints.
While the base of the participant's skull is in the therapist's palm, the therapist will apply pressure equal to the weight of the participant's head with his/her second, third and fourth fingers on the participant's rectus capitis posterior and obliqus capitis superior muscles for 5 minutes.
In order for eye movements not to affect the suboccipital muscle tone, the participants will be asked to close their eyes during the application.
|
A hand-held pressure algometer will be used to record the pressure pain threshold (PPT), defined as the level at which gradually increasing pressure becomes painful.
Pressure algometry has shown high intratest reliability in asymptomatic individuals over the suboccipital area and upper trapezius.
PPT levels will be measured bilaterally over the neck angle over the middle of the anterior surface of the upper trapezius; and over the rectus capitis posterior major (RCPM) muscle.
The physiotherapist will use an increasing pressure of approximately 1 kg/cm²/s.
The average of three measurements with a 30-second rest period will be taken for analysis.
Two measurements will be taken, before and after.
The degrees obtained as a result of the Range of Motion (ROM) measurements are made with a universal manual goniometer.
Goniometer is still the most commonly used method for ROM measurements.
For all ROM measurements to be performed, the necessary measurements can be taken based on the American Academy of Orthopaedic Surgeons (AAOS) guidelines .
The flexion, extension, right and left rotation angles of the cervical region will be measured and recorded with the goniometer in the sitting position of the person.
The measurement will be made twice, before and after the application.
Balance performance will be assessed using the Balance Error Scoring System (BESS), known in Turkish as DHPS. Subjects must maintain test positions for 20 seconds under 6 conditions with eyes closed and no support: 2 surfaces (flat and foam) and 3 stance positions (double-foot, single-foot, tandem). A laboratory floor will serve as the flat surface, and an exercise mat will serve as the foam surface. All subjects will perform the conditions in this sequence: double-foot flat, single-foot flat, tandem flat, double-foot foam, single-foot foam, tandem foam, both pre-test and post-test. Each 20-second period will be timed with a stopwatch, and each error within this period will count as 1 point. Each test condition has a maximum error score of 10. Errors include:
The sense of joint position in the cervical region will be evaluated in four positions: flexion, extension, right rotation, and left rotation, using a goniometer.
Participants will sit upright with arms at their sides, looking ahead.
The physiotherapist will passively move the participant's head to 65% of the maximum joint range of motion, previously determined, minimizing vestibular function effects.
After holding the head in position for three seconds, participants will be asked to remember the position.
Subsequently, they will be instructed to return their head to the neutral position and then actively move it to the previously determined point.
The degree of error between the target and achieved positions will be measured.
The procedure will be conducted with the patient lying on their back.
The practitioner will be seated on a stool at the top of the examination table, their forearm in contact with the surface.
After locating the occipital condyles through palpation, the practitioner will position their fingers in the slightly concave region between the occiput and the second cervical vertebra's spinous process.
The patient's head will be gently elevated by the practitioner flexing their metacarpophalangeal joints.
With the patient's skull base resting in the practitioner's palm, pressure equivalent to the weight of the patient's head will be applied to the rectus capitis posterior and obliquus capitis superior muscles using the practitioner's second, third, and fourth fingers for a duration of 5 minutes.
To prevent eye movements from influencing suboccipital muscle tone, patients will be instructed to keep their eyes closed during the procedure.
|
|
Sham Comparator: Suboccipital Hold
No suboccipital relaxation will be applied to the control group, and the experimental group will be kept in contact with the suboccipital region for the same period of time, namely 5 minutes, and the measurements will be recorded before and after the application.
|
A hand-held pressure algometer will be used to record the pressure pain threshold (PPT), defined as the level at which gradually increasing pressure becomes painful.
Pressure algometry has shown high intratest reliability in asymptomatic individuals over the suboccipital area and upper trapezius.
PPT levels will be measured bilaterally over the neck angle over the middle of the anterior surface of the upper trapezius; and over the rectus capitis posterior major (RCPM) muscle.
The physiotherapist will use an increasing pressure of approximately 1 kg/cm²/s.
The average of three measurements with a 30-second rest period will be taken for analysis.
Two measurements will be taken, before and after.
The degrees obtained as a result of the Range of Motion (ROM) measurements are made with a universal manual goniometer.
Goniometer is still the most commonly used method for ROM measurements.
For all ROM measurements to be performed, the necessary measurements can be taken based on the American Academy of Orthopaedic Surgeons (AAOS) guidelines .
The flexion, extension, right and left rotation angles of the cervical region will be measured and recorded with the goniometer in the sitting position of the person.
The measurement will be made twice, before and after the application.
Balance performance will be assessed using the Balance Error Scoring System (BESS), known in Turkish as DHPS. Subjects must maintain test positions for 20 seconds under 6 conditions with eyes closed and no support: 2 surfaces (flat and foam) and 3 stance positions (double-foot, single-foot, tandem). A laboratory floor will serve as the flat surface, and an exercise mat will serve as the foam surface. All subjects will perform the conditions in this sequence: double-foot flat, single-foot flat, tandem flat, double-foot foam, single-foot foam, tandem foam, both pre-test and post-test. Each 20-second period will be timed with a stopwatch, and each error within this period will count as 1 point. Each test condition has a maximum error score of 10. Errors include:
The sense of joint position in the cervical region will be evaluated in four positions: flexion, extension, right rotation, and left rotation, using a goniometer.
Participants will sit upright with arms at their sides, looking ahead.
The physiotherapist will passively move the participant's head to 65% of the maximum joint range of motion, previously determined, minimizing vestibular function effects.
After holding the head in position for three seconds, participants will be asked to remember the position.
Subsequently, they will be instructed to return their head to the neutral position and then actively move it to the previously determined point.
The degree of error between the target and achieved positions will be measured.
The procedure will be conducted with the patient lying on their back.
The practitioner will be seated on a stool at the top of the examination table, their forearm in contact with the surface.
After locating the occipital condyles through palpation, the practitioner will position their fingers in the slightly concave region between the occiput and the second cervical vertebra's spinous process.
The patient's head will be gently elevated by the practitioner flexing their metacarpophalangeal joints.
With the patient's skull base resting in the practitioner's palm, pressure equivalent to the weight of the patient's head will be applied to the rectus capitis posterior and obliquus capitis superior muscles using the practitioner's second, third, and fourth fingers for a duration of 5 minutes.
To prevent eye movements from influencing suboccipital muscle tone, patients will be instructed to keep their eyes closed during the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Proprioception
Time Frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
|
Cervical Joint Position Sense Assessment was performed with the Reposition Test using a goniometer.
|
Change from baseline to final examination immediate after 5 minutes of manual therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Pressure Threshold
Time Frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
|
Pain pressure threshold of the upper trapezius and rectus capitis muscles was measured with a handheld algometer
|
Change from baseline to final examination immediate after 5 minutes of manual therapy
|
|
Range of Motion
Time Frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
|
A goniometer was utilized to assess the range of motion for cervical flexion, extension, and rotation.
|
Change from baseline to final examination immediate after 5 minutes of manual therapy
|
|
Balance Error Scoring
Time Frame: Change from baseline to final examination immediate after 5 minutes of manual therapy
|
Balance Error Scoring System was used to measure balance performances.
|
Change from baseline to final examination immediate after 5 minutes of manual therapy
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Bvu1903
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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