Nonspecific Chronic Neck PainNCT03933267
Cervical Sensorimotor Control Training in Chronic Neck Pain
A study testing Conventional Exercises in people with Nonspecific Chronic Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Impaired cervical joint position sense is associated with neck pain. This study will determine the effects of sensorimotor control training exercises on cervical joint position, pain, ROM and function in nonspecific chronic neck pain. There will be two groups ; experimental and control. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonspecific Chronic Neck Pain
- What is being tested?
- Conventional Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Apr 2019to 30 Jun 2019
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20 to 50 years
- Non specific neck pain
- Insidious neck pain for at least 3 month
- Average pain intensity over the past week >4 on Numeric Pain Rating Scale(NPRS)
Who cannot join
- Previous history of neck and head trauma or surgery
- Inflammatory joint disease
- Systemic conditions
- Cognitive impairment
- Taking four or more medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cervical Sensorimotor Control Training in Nonspecific Chronic Neck Pain
Impaired cervical joint position sense is associated with neck pain. This study will determine the effects of sensorimotor control training exercises on cervical joint position, pain, ROM and function in nonspecific chronic neck pain. There will be two groups ; experimental and control. Half of study group will receive cervical sensorimotor control training exercises and half of study group will receive conventional physiotherapy protocol.
Read the detailed description
The study is Randomized Control Trail , which is being conducted in physical therapy Out patient department of Pakistan Railway hospital (April 2019-July 2019) . Sample size of 18 individual was calculated using Epitool with 95% confidence interval (CI), and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups , 9 in cervical Sensori-motor training group and 9 in conventional physiotherapy protocol group by sealed envelope method.
Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) for neck pain in common and the experimental group will receive cervical sensorimotor control training in addition to conventional protocol.
Assessment will be done on baseline and 6th week.
Data will be analysed on SPSS version 21.
- Conditions
- Nonspecific Chronic Neck Pain
- Being tested
- Cervical sensorimotor control training exercises, Conventional Exercises
- Keywords
- Cervical Pain, Kinesthesis
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical sensorimotor control training exercisesOther
Also called Prioprioception Exercises
Cervical sensory motor training exercises consisting of cervical position sense and cervical movement sense exercises with 3 levels of difficulty and 5 repetitions * 3 sets for each exercise will be given. Some exercises are:
Head relocation with laser feedback:
head relocation to neutral and predetermined position with eyes opened (in horizontal / vertical direction) (5 reps x 3 sets) Head relocation to neutral, predetermined and to specific targets with eyes opened (in diagonal directions) (5 reps x 3 sets) Head relocation to neutral and predetermined position with eyes closed (in all directions)(5 reps x 3 sets) In addition to it conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility.
Conventional ExercisesOther
conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | This group of participant will receive Cervical sensorimotor control training exercises. In addition to it conventional physical therapy protocol will be given. Receives: Other: Cervical sensorimotor control training exercises |
| Group II Control | Active comparator | this group of participant will receive Conventional physical therapy protocol. Receives: Other: Conventional Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Joint position error
The task is to return head to the starting position as accurately as possible. Three trials will be performed of right and left rotation and extension. An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
Measured: Baseline
Cervical Joint position error
The task is to return head to the starting position as accurately as possible. Three trials will be performed of right and left rotation and extension. An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
Measured: post 6th week
Clinical test of sensory interaction and balance (CTSIB)
This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise. Begin timing each trial using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
Measured: Baseline
Clinical test of sensory interaction and balance (CTSIB)
This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise. Begin timing each trial using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
Measured: post 6th week
Secondary outcomes (8)
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Measured: Baseline
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at 6th week of intervention.
Measured: post 6th week
Neck Disability Index (NDI):
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured at Baseline before Intervention.
Measured: Baseline
Neck pain and disability index (NDI):
Neck Disability Index (NDI) is a questionnaire designed to assess how neck pain has affected patient's ability to manage in everyday life. It has total 10 sections, For each section the total possible score is 5: if the first statement is marked the section score = 0, if the last statement is marked it = 5. If all ten sections are completed the score is calculated and converted into percentages. The maximum Score of Neck Disability Index (NDI) is 50. It is measured after 6th week of Intervention.
Measured: post 6th week
CROM (inclinometer)
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: Baseline
CROM (inclinometer)
A cervical range of motion (CROM) inclinometer will be use to assess cervical range of motion in flexion, extension, left right lateral flexion and left-right rotation. Participants will be seated upright and asked to actively move their neck in each direction.
Measured: post 6th week
Patient-Specific Functional Scale (PSFS)
The patient-specific functional scale (PSFS) will be use to assess participants' functional status. Participants will be ask to nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their neck pain. These activities will be rated on a 0-10 scale, where 0 is unable to perform the activity and 10 is able to perform the activity at same. An average of all activities scores will be use for analysis
Measured: baseline
Patient-Specific Functional Scale (PSFS)
The patient-specific functional scale (PSFS) will be use to assess participants' functional status. Participants will be ask to nominate 3 to 5 activities that they are unable to do or having difficulty doing because of their neck pain. These activities will be rated on a 0-10 scale, where 0 is unable to perform the activity and 10 is able to perform the activity at same. An average of all activities scores will be use for analysis
Measured: post 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start25 Apr 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nonspecific Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933267
- Sponsor's protocol ID
- RiphahIU Aruba Iram
- Status last verified
- Aug 2019
- First submitted
- 27 Apr 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Javanshir K, Ortega-Santiago R, Mohseni-Bandpei MA, Miangolarra-Page JC, Fernandez-de-Las-Penas C. Exploration of somatosensory impairments in subjects with mechanical idiopathic neck pain: a preliminary study. J Manipulative Physiol Ther. 2010 Sep;33(7):493-9. doi: 10.1016/j.jmpt.2010.08.022.
PubMed 20937427Saadat M, Salehi R, Negahban H, Shaterzadeh MJ, Mehravar M, Hessam M. Postural stability in patients with non-specific chronic neck pain: A comparative study with healthy people. Med J Islam Repub Iran. 2018 Apr 23;32:33. doi: 10.14196/mjiri.32.33. eCollection 2018.
PubMed 30159284de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
PubMed 25983238Beinert K, Taube W. The effect of balance training on cervical sensorimotor function and neck pain. J Mot Behav. 2013;45(3):271-8. doi: 10.1080/00222895.2013.785928.
PubMed 23663191Swait G, Rushton AB, Miall RC, Newell D. Evaluation of cervical proprioceptive function: optimizing protocols and comparison between tests in normal subjects. Spine (Phila Pa 1976). 2007 Nov 15;32(24):E692-701. doi: 10.1097/BRS.0b013e31815a5a1b.
PubMed 18007229
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cervical Sensorimotor Control Training in Nonspecific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03933267
- Acronym / sponsor ID
- RiphahIU Aruba Iram
- Conditions
- Nonspecific Chronic Neck Pain
- Keywords
- Cervical Pain, Kinesthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 1 May 2019 (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.
Impaired cervical joint position sense is associated with neck pain. This study will determine the effects of sensorimotor control training exercises on cervical joint position, pain, ROM and function in nonspecific chronic neck pain. There will be two groups ; experimental and control. Half of study group will receive cervical sensorimotor control training exercises and half of study group will receive conventional physiotherapy protocol.
Detailed description
The study is Randomized Control Trail , which is being conducted in physical therapy Out patient department of Pakistan Railway hospital (April 2019-July 2019) . Sample size of 18 individual was calculated using Epitool with 95% confidence interval (CI), and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups , 9 in cervical Sensori-motor training group and 9 in conventional physiotherapy protocol group by sealed envelope method.
Both groups will receive conventional physiotherapy protocol (hot pack, stretching exercises and strengthening exercises) for neck pain in common and the experimental group will receive cervical sensorimotor control training in addition to conventional protocol.
Assessment will be done on baseline and 6th week.
Data will be analysed on SPSS version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Both experimental and control groups will be treated simultaneously with one treatment option common to both groups
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Cervical sensorimotor control training exercisesThis group of participant will receive Cervical sensorimotor control training exercises. In addition to it conventional physical therapy protocol will be given. |
| Group II Control | Active comparator | Other: Conventional Exercisesthis group of participant will receive Conventional physical therapy protocol. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20 to 50 years
- Non specific neck pain
- Insidious neck pain for at least 3 month
- Average pain intensity over the past week >4 on Numeric Pain Rating Scale(NPRS)
Key exclusion criteria (5 listed)
- Previous history of neck and head trauma or surgery
- Inflammatory joint disease
- Systemic conditions
- Cognitive impairment
- Taking four or more medications
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 |
|---|---|---|
| Cervical sensorimotor control training exercisesAlso: Prioprioception ExercisesCervical sensory motor training exercises consisting of cervical position sense and cervical movement sense exercises with 3 levels of difficulty and 5 repetitions * 3 sets for each exercise will be given. Some exercises are: Head relocation with laser feedback: head relocation to neutral and predetermined position with eyes opened (in horizontal / vertical direction) (5 reps x 3 sets) Head relocation to neutral, predetermined and to specific targets with eyes opened (in diagonal directions) (5 reps x 3 sets) Head relocation to neutral and predetermined position with eyes closed (in all directions)(5 reps x 3 sets) In addition to it conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility. | Other | Group I |
| Conventional Exercisesconventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients. | Other | Group II Control |
Primary outcome
Cervical Joint position error
Time frame: Baseline
The task is to return head to the starting position as accurately as possible. Three trials will be performed of right and left rotation and extension. An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
Cervical Joint position error
Time frame: post 6th week
The task is to return head to the starting position as accurately as possible. Three trials will be performed of right and left rotation and extension. An average absolute error of > 4.5° in any direction is indicative of a deficit in cervical joint position sense
Clinical test of sensory interaction and balance (CTSIB)
Time frame: Baseline
This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise. Begin timing each trial using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
Clinical test of sensory interaction and balance (CTSIB)
Time frame: post 6th week
This test is design to assess how well an older adult is using sensory inputs when one or more sensory systems are compromise. Begin timing each trial using a stopwatch. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall
8 secondary outcomes
Numeric pain rating scale (NPRS)
Time frame: Baseline
Numeric pain rating scale (NPRS)
Time frame: post 6th week
Neck Disability Index (NDI):
Time frame: Baseline
Neck pain and disability index (NDI):
Time frame: post 6th week
CROM (inclinometer)
Time frame: Baseline
CROM (inclinometer)
Time frame: post 6th week
Patient-Specific Functional Scale (PSFS)
Time frame: baseline
Patient-Specific Functional Scale (PSFS)
Time frame: post 6th week
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 9 Aug 2019.
- Background: PubMed 20937427Javanshir K, Ortega-Santiago R, Mohseni-Bandpei MA, Miangolarra-Page JC, Fernandez-de-Las-Penas C. Exploration of somatosensory impairments in subjects with mechanical idiopathic neck pain: a preliminary study. J Manipulative Physiol Ther. 2010 Sep;33(7):493-9. doi: 10.1016/j.jmpt.2010.08.022.
- Background: PubMed 30159284Saadat M, Salehi R, Negahban H, Shaterzadeh MJ, Mehravar M, Hessam M. Postural stability in patients with non-specific chronic neck pain: A comparative study with healthy people. Med J Islam Repub Iran. 2018 Apr 23;32:33. doi: 10.14196/mjiri.32.33. eCollection 2018.
- Background: PubMed 25983238de Vries J, Ischebeck BK, Voogt LP, van der Geest JN, Janssen M, Frens MA, Kleinrensink GJ. Joint position sense error in people with neck pain: A systematic review. Man Ther. 2015 Dec;20(6):736-44. doi: 10.1016/j.math.2015.04.015. Epub 2015 May 2.
- Background: PubMed 23663191Beinert K, Taube W. The effect of balance training on cervical sensorimotor function and neck pain. J Mot Behav. 2013;45(3):271-8. doi: 10.1080/00222895.2013.785928.
- Background: PubMed 18007229Swait G, Rushton AB, Miall RC, Newell D. Evaluation of cervical proprioceptive function: optimizing protocols and comparison between tests in normal subjects. Spine (Phila Pa 1976). 2007 Nov 15;32(24):E692-701. doi: 10.1097/BRS.0b013e31815a5a1b.
- Individual participant dataSharing planned: No
Related trials for Nonspecific Chronic Neck Pain
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Not yet recruiting
Comparative Effectiveness Randomised Controlled Trial of Hybrid Muscle Conditioning
Chronic Nonspecific Neck Pain
RecruitingObservational study
Physical Profile of Cervicogenic Headache: Comparison With Neck Pain and Healthy Controls
Cervicogenic Headache, Chronic Neck Pain
Enrolling by invitation
Workplace Exercise Therapy With or Without Manual Therapy in Chronic Spinal Pain
Back Pain, Neck Pain
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.
Huma Riaz, PHD* 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 Conventional Exercises in people with Nonspecific Chronic 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 4 inclusion and 5 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 9 Aug 2019. 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 Joint position error (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03933267, which also lists 5 linked publications.
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 9 Aug 2019.