Neck PainNCT05074615
Effects of Cranio-cervical Flexion on Cervical Proprioception
A study testing Cranio-Cervical Flexion Training and Conventional Therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of cranio-cervical flexion training on the cervical proprioception and pain in patients with mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Cranio-Cervical Flexion Training and Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Nov 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Vertebrobasilar insufficiency.
- Any history of serious underlying pathology, cervical trauma, structural deformities, genetic spinal disorders or previous spinal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cranio-cervical Flexion Training on Cervical Proprioception in Patients With Mechanical Neck Pain
To determine the effects of cranio-cervical flexion training on the cervical proprioception and pain in patients with mechanical neck pain.
Read the 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.
- Conditions
- Neck Pain
- Being tested
- Cranio-Cervical Flexion Training, Conventional Therapy
- Keywords
- Mechanical neck pain, Proprioceptive training, Deep cervical flexors
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranio-Cervical Flexion TrainingOther
Participants of this group will receive conventional training along with Cranio-cervical flexion training:
- The pressure cuff is placed behind the neck just next to the occiput and inflated up to a baseline pressure of 20 mmHg. The patient is asked to perform Cranio-Cervical Flexion (CCF) to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the patient is instructed to maintain the contraction for 10 sec for 10 repetitions with brief rest periods between each contraction i.e., 3-5 seconds. Once a set of 10 repetitions of 10 sec is achieved at one target level, the exercise is progressed to train at the next target level up to the final target level at 30 mmHg.
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.
Conventional TherapyOther
Participants of this group will receive only conventional therapy and home plan will be given which includes;
- Hot pack placed on the posterior neck for 15 minutes.
- Transcutaneous electrical nerve stimulation (TENS) with a frequency of 80 Hz for 20 minutes with 10-30 mA intensity.
- Isometric exercises: Isometric neck flexion, extension, side bending exercises. 10 repetitions. Hold period is 10 seconds for each movement. Resistance would be provided manually by the therapist.
- Stretching exercises: Passive stretching for Sternocleidomastoid, Trapezius, Pectoralis Major. 10 reps and each stretch maintained for 10 seconds.
- Home Plan: Patients will be given a home plan of self-stretches and isometrics and instructions on how to perform and number of repetitions will be guided. Exercise protocol will consist of 25 minutes. Exercise will consist of total 3 sessions/week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cranio-Cervical Flexion Training Group | Experimental | 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. Receives: Other: Cranio-Cervical Flexion Training; Other: Conventional Therapy |
| Conventional Therapy Group | Active comparator | 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. Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Range of Motion
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.
Measured: 3 weeks
Secondary outcomes (1)
Numeric Pain Rating Scale
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start2 Nov 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Rauf, Master, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074615
- Sponsor's protocol ID
- REC/00945 Laiba Gul
- Status last verified
- Mar 2022
- First submitted
- 29 Sep 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranio-cervical Flexion Training on Cervical Proprioception in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT05074615
- Acronym / sponsor ID
- REC/00945 Laiba Gul
- Conditions
- Neck Pain
- Keywords
- Mechanical neck pain, Proprioceptive training, Deep cervical flexors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of cranio-cervical flexion training on the cervical proprioception and pain in patients with mechanical neck pain.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranio-Cervical Flexion Training Group | Experimental | Other: Cranio-Cervical Flexion Training, Other: Conventional TherapyParticipants 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. |
| Conventional Therapy Group | Active comparator | Other: Conventional TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Vertebrobasilar insufficiency.
- Any history of serious underlying pathology, cervical trauma, structural deformities, genetic spinal disorders or previous spinal surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranio-Cervical Flexion TrainingParticipants of this group will receive conventional training along with Cranio-cervical flexion training: * The pressure cuff is placed behind the neck just next to the occiput and inflated up to a baseline pressure of 20 mmHg. The patient is asked to perform Cranio-Cervical Flexion (CCF) to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the patient is instructed to maintain the contraction for 10 sec for 10 repetitions with brief rest periods between each contraction i.e., 3-5 seconds. Once a set of 10 repetitions of 10 sec is achieved at one target level, the exercise is progressed to train at the next target level up to the final target level at 30 mmHg. 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. | Other | Cranio-Cervical Flexion Training Group |
| Conventional TherapyParticipants of this group will receive only conventional therapy and home plan will be given which includes; * Hot pack placed on the posterior neck for 15 minutes. * Transcutaneous electrical nerve stimulation (TENS) with a frequency of 80 Hz for 20 minutes with 10-30 mA intensity. * Isometric exercises: Isometric neck flexion, extension, side bending exercises. 10 repetitions. Hold period is 10 seconds for each movement. Resistance would be provided manually by the therapist. * Stretching exercises: Passive stretching for Sternocleidomastoid, Trapezius, Pectoralis Major. 10 reps and each stretch maintained for 10 seconds. * Home Plan: Patients will be given a home plan of self-stretches and isometrics and instructions on how to perform and number of repetitions will be guided. Exercise protocol will consist of 25 minutes. Exercise will consist of total 3 sessions/week for 3 weeks | Other | Conventional Therapy Group, Cranio-Cervical Flexion Training Group |
Primary outcome
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.
1 secondary outcome
Numeric Pain Rating Scale
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad Rauf, Master principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranio-Cervical Flexion Training and Conventional Therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Range of Motion (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.