NCT06761391

Brief Summary

Suboccipital release is a straightforward technique beneficial for addressing musculoskeletal complaints like neck pain and headaches. This versatile method aids the autonomic system by manipulating the occipital-atlanto region, specifically regulating the parasympathetic system rather than the sympathetic system targeted by most osteopathic treatments. Studies indicate this technique enhances range of motion and balance in the lower extremities of both healthy and pre-existing patients due to fascia connections throughout the body. Suboccipital muscle release increases cervical spine range of motion, facilitating physical therapy. Myofascial release significantly boosts joint flexibility and range of motion (ROM) without reducing strength or performance. The rectus capitus posterior minor (RCPM) muscle, dense with spindles, is crucial in the suboccipital region for balance and pain proprioception. Trauma-induced atrophy in this muscle is strongly linked to chronic neck pain and reduced standing balance. A case report showed that a patient undergoing a personalized balance program exhibited significant balance improvement, suggesting that balance training should be considered for cervicogenic pain intervention strategies. Neck muscle spasms or fatigue can impair proprioception and postural control, with prolonged unilateral cervical muscle contraction increasing neck proprioceptor sensitivity. Muscle fatigue-related interstitial inflammatory mediators can sensitize muscle spindles. This study will explore suboccipital relaxation's acute effects on pressure pain threshold, range of motion, balance, and joint position sense in healthy individuals based on existing literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

December 22, 2024

Last Update Submit

January 5, 2025

Conditions

Keywords

suboccipital releaseneck proprioceptionpain pressure threshold

Outcome Measures

Primary Outcomes (1)

  • Neck Proprioception

    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 Outcomes (3)

  • Pain Pressure Threshold

    Change from baseline to final examination immediate after 5 minutes of manual therapy

  • Range of Motion

    Change from baseline to final examination immediate after 5 minutes of manual therapy

  • Balance Error Scoring

    Change from baseline to final examination immediate after 5 minutes of manual therapy

Study Arms (2)

Suboccipital Myofascial Release

EXPERIMENTAL

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.

Diagnostic Test: Pain Pressure ThresholdDiagnostic Test: Cervical Range of MotionDiagnostic Test: Balance Error ScoringDiagnostic Test: Cervical Joint Position SenseOther: Suboccipital manual therapy

Suboccipital Hold

SHAM COMPARATOR

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.

Diagnostic Test: Pain Pressure ThresholdDiagnostic Test: Cervical Range of MotionDiagnostic Test: Balance Error ScoringDiagnostic Test: Cervical Joint Position SenseOther: Suboccipital manual therapy

Interventions

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.

Suboccipital HoldSuboccipital Myofascial Release

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.

Suboccipital HoldSuboccipital Myofascial Release
Balance Error ScoringDIAGNOSTIC_TEST

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: 1. Lifting hands above the iliac crest, 2. Opening eyes, 3. Taking a step,staggering, falling, 4. Flexing or abducting the hip joint beyond 30°, 5. Lifting the forefoot or heel off the ground, 6. Leaving the test position

Suboccipital HoldSuboccipital Myofascial Release

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.

Suboccipital HoldSuboccipital Myofascial Release

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.

Suboccipital HoldSuboccipital Myofascial Release

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers willing to participate in the study.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Safran E, Kaya Y. Contextual and placebo effects of suboccipital myofascial release: evaluating its influence on pain threshold, cervical range of motion, and proprioception. BMC Musculoskelet Disord. 2025 May 21;26(1):502. doi: 10.1186/s12891-025-08741-6.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 7, 2025

Study Start

June 2, 2024

Primary Completion

October 2, 2024

Study Completion

October 2, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations