- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535879
Pressure Biofeedback on Deep Cervical Flexor Muscles
The Investigation of the Effect of Pressure Biofeedback on the Endurance of Deep Cervical Flexor Muscles in School Teachers With Mechanical Neck Pain : A Randomized Controlled Trial
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Mechanical neck pain is the most frequent musculoskeletal disorder. It is characterized by feeling of pain, stiffness and loss of function in the cervical region. It is often related to poor posture, repetitive strain, or local soft tissue dysfunction. Evidence suggests that this disorder significantly influences daily life activities and quality of life. Mechanical neck pain is one of the leading causes of global disability. It shows the importance of physiotherapeutic interventions for the associated pain and functional limitations. The prevalence of this condition has been increasing. Particularly among individuals who engage in prolonged periods of desk work or activities requiring sustained postural maintenance .School teachers are particularly impacted due to the demanding nature of their work.
Studies report a prevalence of 35% to 65% among teachers. primarily caused by prolonged static postures, repetitive overhead activities like writing on boards, and poor ergonomic practices. The shift toward virtual teaching has further worsen the issue by increasing screen time, leading to cervical strain=. Additionally, psychological stress and heavy workloads associated with teaching contribute significantly to musculoskeletal pain.This negatively affects teachers' physical health, productivity, and overall quality of life. Targeting school teachers, a population with unique occupational demands, the study emphasizes early muscle-specific interventions to prevent chronic neck pain and promote functional recovery. School teachers build the future of the nation, for this reason our study is highlighting the importance of preventing any injuries that may cause absenteeism. It also highlights the importance of integrating workplace health promotion and ergonomic solutions into physiotherapy strategies for long-term benefits. Previous studies on cervical impairments indicated that lower endurance in deep cervical flexors is responsible for neck pain. This leads to muscular insufficiency as well as impaired activation. In such cases, poor endurance of deep cervical flexor muscles has been observed and weakness of the anterior cervical flexor muscles can lead to head and neck postural imbalances .A restoration of deep cervical flexor muscle function has been suggested clinically for managing neck pain, but still limited evidence on its efficacy in work-related neck pain has been noted . Mechanical neck pain is associated with disfunction in proprioception. The body's ability to sense joint movement and joint position. These disfunctions can disrupt sensorimotor control causing potential exacerbating pain and functional limitations .
Previous studies has also showed that individuals with neck pain experience increased joint position limitations that indicate compromised cervical proprioception. The imbalance between superficial and deep flexor muscles during neck pain causes DCF to weaken. Mainly leading to hyperactivity of the superficial neck muscles and loss of correct alignment. This leads many cervical deficits like muscular insufficiency and poor muscle activation . General musculoskeletal treatment such as stretching and strengthening of the neck muscles were used as an intervention to reduce neck pain. Severe cases of mechanical neck pain may cause functional disability by limiting the teacher from performing his tasks on daily bases due to the severe pain and discomfort.
Pressure biofeedback is a device that is designed to provide feedback for ensuring the quality and precision in exercise performance and testing. It is used to monitor and provide feedback on the body movement during exercise. Promoting effective exercise to improve neck and back pain by targeting deep muscles. The original value of our study lies in comparing the effectiveness of a combined pressure biofeedback training targeting deep cervical flexor muscles with general musculoskeletal training. consisting non specific neck muscle strengthening and stretching to improve endurance, reduce mechanical neck pain, increase proprioception and improve posture and functional disability.
The investigator expects the results and findings of this study will attribute in filling the gap in musculoskeletal and ergonomic rehabilitation. By highlighting the impact of combined training for deep cervical flexor muscles for school teachers using pressure biofeedback increases deep cervical flexor endurance, reduces pain and increases proprioception and functional disability. The uniqueness of this study is that it investigates the effect of adding pressure biofeedback training to usual care for mechanical neck pain. Specially considering the deep cervical flexor (DCF) muscles.
Previous studies have ignored DCF dysfunction in favor of superficial muscle assessment, despite its contribution to chronic neck pain .Previous study limitations, such as insufficient sample sizes, have further limited the generalizability of the findings. Targeting schoolteachers, who are especially prone to neck pain due to their working conditions .This study clearly combines pressure biofeedback assessment of deep cervical flexor (DCF) endurance with cervical joint position error testing to examine proprioception. Primarily to address the sensory-motor control often impaired in cervical disorders .Impairments in proprioception have been related to poor DCF performance .The intervention design combines ergonomic principles with health promotion strategies in occupational settings, aiming to address the physiological and functional aspects of neck pain .
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Küçükçekmece
-
Istanbul, Küçükçekmece, Turkey (Türkiye), 34290
- Özel Ihsan Atakent Okulları
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female School teachers.
- Age between 22 and 65 years old.
- Presence of Mechanical Neck Pain
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control Group
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. |
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. |
|
Experimental: Pressure Biofeedback Training
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.
|
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.
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion
Time Frame: From enrollment time Until after Intervention of 8 weeks
|
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
Time Frame: From enrollment time until after Intervention 8 weeks
|
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
Time Frame: From enrollment time until after Intervention 8 weeks
|
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
Time Frame: From enrollment until after intervention 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index
Time Frame: From enrollment Until after intervention 8 weeks
|
Assessing 10 domains such as reading, lifting, concentration, driving, personal care, sleeping, driving and work.
The scores are are taken from 0-5 for each domain and then converted to percentage to measure the level of functional disability.
0 there is no pain , 5 the worse pain.
|
From enrollment Until after intervention 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Blomgren J, Strandell E, Jull G, Vikman I, Roijezon U. Effects of deep cervical flexor training on impaired physiological functions associated with chronic neck pain: a systematic review. BMC Musculoskelet Disord. 2018 Nov 28;19(1):415. doi: 10.1186/s12891-018-2324-z.
- 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.
- Iqbal ZA, Alghadir AH, Anwer S. Efficacy of Deep Cervical Flexor Muscle Training on Neck Pain, Functional Disability, and Muscle Endurance in School Teachers: A Clinical Trial. Biomed Res Int. 2021 Jan 13;2021:7190808. doi: 10.1155/2021/7190808. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-06
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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