Pressure Biofeedback on Deep Cervical Flexor Muscles

NCT07535879 | Enrolling By Invitation

• 1 other identifier: 25-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to reduce mechanical neck pain and improve deep cervical flexor muscle endurance by using pressure biofeedback training for school educators to improve their job satisfaction and quality of life. The main question is Can adding Pressure Biofeedback training to the General musculoskeletal Exercise Increase Deep Cervical Flexor Muscle Endurance , Functional Disability and reduce Pain than only implementing General Musculoskeletal Exercise in School Teachers ? Researcher will Compare General Musculoskeletal Exercise Treatment with a General Musculoskeletal exercise Treatment including Pressure Biofeedback Training Participants will: 1- undergo this trial for 8 weeks 2 - Three times per week for 30 minute per session

Conditions

Neck Pain; School Based Intervention; Functional Disabilities

Keywords

Deep Cervical Muscle activation; deep cervical muscles; Functional disability; School Teachers; Pressure Biofeedback Training; Mechanical Neck Pain

Outcome Measures

Primary Outcomes (4)

• Cervical Range of Motion

  Cervical range of motion using a goniometer, Flexion and Extension of the neck as the axis of the goniometer is aligned parallel to the external auditory meatus (ear canal). The stationary arm is placed parallel to the floor while the moving arm is aligned with the base of the nares (nostrils). The patient is instructed to gently flex the chin toward the chest . Then arch the head backwards for extension

  From enrollment time Until after Intervention of 8 weeks

• Cranio-Cervical Flexion Test

  clinical test of neuromotor control including the activation and endurance of deep flexors of the cervical spine. This test includes the patient to perform a "yes" like nod. This move is the anatomical action of deep cervical flexors against pressure biofeedback unit.The first stage of this test pressure should increase by 2 mm Hg. The patient is asked to obtain this position for 10 seconds. Then the patient relaxes back to 20 mm Hg. Then we increase the pressure again this time to 24 mm Hg using the same action and hold for 10 seconds. The patient must do this until he/she has reached a pressure of 30 mm Hg. This test should be repeated two times without fatigue

  From enrollment time until after Intervention 8 weeks

• Numeric Pain Scale

  It is a pain screening evaluation tool that is commonly used to evaluate the severity of pain at the moment in time, using scale from 0 - 10, with zero meaning " no pain" and 10 meaning " the worst pain"

  From enrollment time until after Intervention 8 weeks

• Cervical Joint position Error Test

  It is a valid test for assessing cervical spine proprioception. In this test, a 40 cm target with 1 cm concentric circles is placed 90 cm away at head height while the patient sits A laser pointer attached to a headband helps the patient align the laser with the target's center to find a neutral head position .With eyes closed, the patient rotates their head and verbally signals when they believe they are back at the starting position before opening their eyes

  From enrollment until after intervention 8 weeks

Secondary Outcomes (1)

• Neck Disability Index

  From enrollment Until after intervention 8 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

General musculoskeletal training (n=30) These exercises will be applied three times a week for 30 minutes over an 8-week time period. General musculoskeletal exercise: 10 minutes stretching, 15 minutes strengthening, and 5 minutes posture correction and proprioception exercises with elastic ball against the wall.

Other: General Musculoskeletal Exercise

Pressure Biofeedback Training

EXPERIMENTAL

intervention group participants will receive pressure biofeedback training in addition to general musculoskeletal training. This will occur three times a week for 20 minutes over an 8-week period. Sessions begin with a 5-minute warm-up consisting of neck stretching. This was done to prepare for the pressure biofeedback, which will increase the strength of the neck. Participants lay supine with the neck in a neutral position, A stabilizer pressure biofeedback unit (Chattanooga Group, Hixson, TN) is placed under the cervical lordosis and inflated to 20 mmHg using a pressure sensor. The therapist then stands beside the participant and instruct them to nod their head slowly at their own speed. When the DCFM are activated, they make the cervical lordosis a little flatter. In this study, this change is measured as a change in pressure measured by the sensor. The activation scores are calculated as the highest pressure that participants could maintain for 10 seconds.

Device: Pressure Biofeedback Training; Other: General Musculoskeletal Exercise

Interventions

Pressure Biofeedback Training DEVICE

intervention group participants will receive pressure biofeedback training in addition to general musculoskeletal training. This will occur three times a week for 20 minutes over an 8-week period. Sessions begin with a 5-minute warm-up consisting of neck stretching. This was done to prepare for the pressure biofeedback, which will increase the strength of the neck. Participants lay supine with the neck in a neutral position, A stabilizer pressure biofeedback unit (Chattanooga Group, Hixson, TN) is placed under the cervical lordosis and inflated to 20 mmHg using a pressure sensor. The therapist then stands beside the participant and instruct them to nod their head slowly at their own speed. When the DCFM are activated, they make the cervical lordosis a little flatter. In this study, this change is measured as a change in pressure measured by the sensor. The activation scores are calculated as the highest pressure that participants could maintain for 10 seconds.

Also known as: General Musculoskeletal Exercise

Pressure Biofeedback Training

General Musculoskeletal Exercise OTHER

These exercises will be applied three times a week for 30 minutes over an 8-week time period. General musculoskeletal exercise: 10 minutes stretching, 15 minutes strengthening, and 5 minutes posture correction and proprioception exercises with elastic ball against the wall.

Control Group; Pressure Biofeedback Training

Eligibility Criteria

• Age: 22 Years - 65 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female School teachers.
• Age between 22 and 65 years old.
• Presence of Mechanical Neck Pain

You may not qualify if:

• Pregnancy.
• Presence due to non-mechanical issues ( inflammatory ,traumatic or systematic conditions)
• Presence of any chronic systematic diseases.
• Presence of any neurological disorder effecting the cervical region

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Özel Ihsan Atakent Okulları

Istanbul, Küçükçekmece, 34290, Turkey (Türkiye)

Location

Related Publications (3)

• Blomgren J,Strandell E,Jull G,Vikman I,Röijezon U

  RESULT

• Iqbal ZA,Alghadir AH,Anwer S

  RESULT

• Jull GA, O'Leary SP, Falla DL. Clinical assessment of the deep cervical flexor muscles: the craniocervical flexion test. J Manipulative Physiol Ther. 2008 Sep;31(7):525-33. doi: 10.1016/j.jmpt.2008.08.003.

  PMID: 18804003 RESULT

Related Links

• Deep Cervical muscle training
• Cranioflexion test
• Deep Cervical muscle Training

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 17, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)