- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05074615
Effects of Cranio-cervical Flexion on Cervical Proprioception
Effects of Cranio-cervical Flexion Training on Cervical Proprioception in Patients With Mechanical Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck pain is a very common health related problem that alters an individual's daily life. In the over-all population and musculoskeletal training, it happens next to low back pain in its frequency. Neck pain has a point incidence of approximately 13% and a lifetime incidence of almost 50%. It is a joint reason for visits in accidents and emergency departments. Neck pain is said to be more common in females than in males and it crests at the middle age. Sedentary lifestyles are contributing to the occurrence of neck pain. Chronic neck pain affects a very significant number when it comes to the adult population. Proprioception involves the body sensations that helps in the proper orientation of the body relative to the movement of joints and bones, in rest and in motion. When the joint position sense is disturbed due to some kind of abnormality, a person adopts an abnormal posture. If this faulty posture continues, this causes abnormalities in the spine and causes impaired stability. The system of proprioception in our body is dependent upon different afferent stimulus reaching towards mechanoreceptors from afferent neurons. Due to the presence of high densities of muscle spindles in the slow twitch fibers in deep, small intrinsic dorsal and sub-occipital muscles play very important role in the control of posture. The cervical musculature has a number of other systems working in congregation including vestibular system, visual as well as central nervous system feedbacks. All of these systems send the signals according to the body and head movements. That is why, the involvement of upper cervical region can cause impaired proprioception and altered afferent stimulus. When many levels of nervous system gets involved, it can impact a change in the sensitivity of muscle spindle and causes one of the major proprioception shortages in cervical patients. For the maintenance of motion, posture and joint position, proprioceptive information has an important role and any factor that disrupts this information may be considered a major reason of incorrect motion patterns and symptoms of chronic recurrent pain.
Cranio-Cervical flexion training which aims to enhance activation of the Deep Cervical flexors (DCFs) and restore coordination between the deep and superficial cervical flexors, is one form of exercise that has been advocated for addressing impaired neuromuscular control of the cervical flexors. Clinical trials examining the effectiveness of this exercise regime have demonstrated positive outcomes in terms of decrease in neck pain and disability, improvement in sitting posture, enhanced neuromuscular control of the cervical flexors in patients with chronic neck pain and also improved proprioceptive acuity of the neck, indicating that proprioception can be enhanced with specific exercise. Cranio-cervical flexion training will be done using Pressure Biofeedback Device by Chattanooga.
A cervical range of motion (CROM) device will be used to assess cervical proprioception. The unit of CROM has three inclinometers attached to it and each inclinometer collects degree of movement in each plane. The CROM device has an advantage over the use of a single inclinometer that it does not have to be moved again to measure the degree of movements in other planes. One the CROM device is mounted on the patient's head, instructions are given to the patient regarding their neutral head movements and target head movements. After that, patient is blindfolded and all the movements are performed with patient being blindfolded. No feedback should be given during the ongoing session. This entire procedure takes around 15 minutes for one individual.
In the light of previous research works, the disturbances in the proprioception involving cervical spine are a very important factor in treating the patients with neck pains. It is very important for a physical therapist to address these deficits and stop the vicious cycle of pain as well as improve proprioception. So, this study is aimed at improving the proprioception and decreasing mechanical neck pain with the help of deep cervical muscles flexion training using pressure biofeedback device.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Islamabad, Punjab, Pakistan, 45720
- SPIRE Medical Mall
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with mechanical neck pain with minimum duration of 4 weeks,
- Pain in the cervical region with moving or palpating the cervical spine,
- upper cervical involvement with or without headache and C1-C2 rotational deficits.
Exclusion Criteria:
- Vertebrobasilar insufficiency.
- Any history of serious underlying pathology, cervical trauma, structural deformities, genetic spinal disorders or previous spinal surgery.
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: Cranio-Cervical Flexion Training Group
Participants of this group will receive conventional training along with cranio-cervical flexion training and home plan. Cranio-cervical flexion training will be given with the help of pressure biofeedback unit. the cuff will be inflated at a specific pressure level and patient will be asked to maintain that pressure and gradually increase it. |
Participants of this group will receive conventional training along with Cranio-cervical flexion training:
Conventional therapy will be given along with home plan. Exercise protocol will consist of 30 minutes. Exercise will have total 3 sessions/week for 3 weeks. Participants of this group will receive only conventional therapy and home plan will be given which includes;
|
Active Comparator: Conventional Therapy Group
Participants of this group will receive only conventional therapy and home plan will be given which includes; hot pack, TENS, neck isometrics and passive stretching of neck musculature.
Home plan will include self-stretches and neck isometrics.
|
Participants of this group will receive only conventional therapy and home plan will be given which includes;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical Range of Motion
Time Frame: 3 weeks
|
The unit of CROM has three inclinometers attached to it and each inclinometer collects degree of movement in each plane..
One the CROM device is mounted on the patient's head, instructions are given to the patient regarding their neutral head movements and target head movements which are Right and Left sided rotation, Right and Left sided lateral flexion and cervical flexion and extension.
After that, patient is blindfolded and all the movements are performed with patient being blindfolded.
No feedback should be given during the ongoing session.
This entire procedure takes around 15 minutes for one individual.
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 3 weeks
|
Numeric Pain Rating Scale will be used to measure the level of pain of patients.
patient will be asked to rate their perceived level of pain from 0 to 10. 0 being no pain and 10 means highest.
|
3 weeks
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00945 Laiba Gul
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.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Cranio-Cervical Flexion Training
-
Zurich University of Applied SciencesRecruitingBruxism | Muscle Strength | EMG | Neck Muscle IssueSwitzerland
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Vanderbilt UniversityCompletedScapular and Cervical Neuromuscular Control Deficits in Musicians With and Without Playing Injuries.Playing Related Musculoskeletal DisordersUnited States
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
Riphah International UniversityCompletedMechanical Neck PainPakistan
-
King Saud UniversityCompletedNeck Pain | Forward Head PostureSaudi Arabia
-
Universidade Federal de Santa MariaCompleted
-
Amager HospitalCompletedHip Flexion StrengthDenmark
-
Unity Health TorontoNot yet recruitingMechanical Ventilator Weaning | Respiratory Muscle Training