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Effects of Cervical Proprioceptive Training in CMNP

Primary Purpose

Chronic Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional physiotherapy
Cervical proprioceptive training
Sponsored by
Mir Arif Hussain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring chronin non traumatic neck pain, Joint position error, Cervical Proprioception, NDI

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mechanical neck pain of Chronic duration (Symptoms present form more than 3 months)
  2. Limitation of cervical ROM
  3. Age 18-55
  4. Men and Women

Exclusion Criteria:

  1. Sharp purser test positive
  2. Vertebral artery insufficiency test positive Neck pain due to:
  3. Inflammatory conditions - infections, ankylosing spondylitis, juvenile arthritis, rheumatoid arthritis and polymyalgia rheumatica.
  4. Metabolic - osteoporosis, osteomalacia, Paget's disease, gout.
  5. Neoplastic - metastases, myeloma, intrathecal tumours.
  6. Referred pain as a result of - angina pectoris, aortic aneurysm, pancoast tumour, diaphragmatic pathology, pharyngial pathology
  7. Neck injury due to trauma

Sites / Locations

  • Federal Government Polyclinic Hospital, Islamabad.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education

It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education. It also include the cervical proprioceptive training

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in patients. The NPRS is a numeric version of the visual analog scale (VAS) in which patient selects a number (0-10) from a horizontal line that best depict the intensity of their pain. 0 represents no pain and 10 represents pain as bad as one can imagine.
Neck Disability Index
NDI is the most widely used instrument for assessing self rated disability in patients with neck pain. It has a total of 10 sections of the following domain: Pain intensity, personal care, carrying weights, reading, headaches, concentration, work, driving, sleep disturbances and recreational activities. Each of the 10 items is scored from 0 (No disability) to 5 (Complete disability).
Range of Motion
Range of motion is a movement potential of a joint in which it moves in its possible availble range. For cervical spine active movements of the neck were recorded in sitting postion. Universal goniometer was used to measure patient's active flexion, extension, Left and right side bendings, left and right side rotations.
Cervical Proprioception
The treatment protocol used for the patients in experimental group was also used as an outcome measurement tool in this study. Patient's cervical proprioception was measured through a procedure adapted by Clark's Joint position error testing. Patients proprioception was assessed on day one and on the last day of their treatment.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2021
Last Updated
September 2, 2021
Sponsor
Mir Arif Hussain
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1. Study Identification

Unique Protocol Identification Number
NCT04941495
Brief Title
Effects of Cervical Proprioceptive Training in CMNP
Official Title
Effects of Proprioceptive Training in the Management of Chronic Mechanical Neck Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 22, 2021 (Actual)
Primary Completion Date
July 12, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mir Arif Hussain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a randomized control trial will be conducted at Federal Government Polyclinic hospital on 44 chronic mechanical neck pain patients. Patients will be recruited in the study through non probability purposive sampling. Random allocation will be done through toss coin method into two groups; Conventional Physiotherapy Control group (n=22) and Proprioceptive training Experimental group (n=22). Research data will be collected through structural questionnaires. Tools will be used to collect data are NPRS, NDI, Goniometer (Cervical ROMs) and proprioception.
Detailed Description
Neck pain is a very common complaint. In the general population and musculoskeletal practice, it occurs second to low back pain in its frequency. Neck pain has a point prevalence of nearly 13% and lifetime prevalence of nearly 50%. Neck pain and disability are prevalent throughout the industrialized society. It is a common reason for visits in accidents and emergency departments. In Chiropractic treatment, Neck pain is the second most common complaint. It Is the result of fast, mechanical, stressful life, lack of mobility and poor posture. Some injury can also lead to neck pain. Sometimes neck pain lasts for a few days and itself goes away, but when it persists for a long time it results in greater problems. Neck pain is said to be more common in females than in males and in peaks at the middle age. Sedentary lifestyles are contributing to the prevalence of neck pain. Neck pain is one of the most debilitating musculoskeletal problems. Neck problems are a significant source of disability to patients, but they have not been studied in detail as low back pain problems. Neck pain can be categorized in many ways i.e. Duration(Acute, Sub acute, Chronic), Intensity, Severity, Type(Mechanical, Neuropathic etc.). Among them duration proves to be the best predictor of outcome. Short duration pain have better prognosis than long standing pain. Mechanical Neck Pain is defined as widespread cervical and/or shoulder pain possessing mechanical properties, such as symptoms aggravated by prolonged or abnormal neck posture, neck mobility and/or by palpation of the neck musculature Mechanical pain originates from the spine or by its supporting structures, such as muscles and ligaments. Pain arising from the facet joints eg, arthritis, diskogenic pain, and myofascial pain can be named as Mechanical pain. It is proposed to be associated with several anatomic structures, predominantly facet joints and uncovertebral(Luschka's joints). The risk factors for mechanical neck pain include abnormal posture, stress, substantial lifting and anxiety. Around 15% females and 10% males suffer from Chronic mechanical neck pain at any one time in life. Clinicians find it challenging to prevent a patient from entering into the chronic phase of their condition. The most mobile part of the vertebral column is the upper cervical spine. And it is at the expense of its mechanical stability. Neuromuscular control to the mobile cervical spine is provided by the highly developed proprioceptive system. Neck pain can lead to disturbed afferent input from the cervical region that may be a possible cause of symptoms such as dizziness, unsteadiness, and visual disturbances. Signs of altered postural stability, cervical proprioception, and head and eye movement control are also said to be the cause of disturbed afferent input. By an abundance of mechanoreceptors, the proprioceptive system of the cervical spine is very well developed especially from the muscle spindles in the deep segmental upper cervical muscles. Muscle spindle afferent are more important because they are the first ones to operate in proprioception. As compared to the lower cervical spine, the upper cervical spine has an abundance of muscle spindle receptors and greater contributions to reflex activity and connections to the visual and vestibular systems. It concludes that patients with the cause of upper cervical complaints in neck pain have a greater chance for balance and visual disturbances than those with complaints of lower cervical spine. The ability to maintain body orientation and posture in relation to the surrounding environment is a key process required for normal functions such as coordinated movements. Sensorimotor control of stable upright posture and head and eye movement depends on afferent information from the vestibular, visual and proprioceptive systems, which all together merge in several areas of the Central Nervous System. Proprioception is important for well-adapted sensorimotor control. Proprioception fulfills roles in feedback sensorimotor control and regulation of muscle stiffness, being specifically important for movement acuity, joint stability, coordination, and balance. For head-eye co-ordination and movement control, cervical proprioception is uniquely important. Musculoskeletal disorders due to pain, effusion, trauma, and fatigue alter the normal proprioceptive mechanism. Neck pain patients are said to have a poor awareness of their head and neck posture, and a few patients are reported to complain about "whopping head" which might be the cause of altered cervical position sense. The rehabilitation procedures in the field of musculoskeletal diseases aim to improve muscular force, joint mobility, and proprioceptive sensibility. Currently, only strength and mobility are evaluated in cervical spine rehabilitation programs, although a wealth of cephalic and neck receptors suggests a major emphasis on proprioceptive information in postural and dynamic functions of the head-neck system. A study by J Arami and colleagues (2014) on the "Applicability of proprioceptive and endurance measurement protocols to treat patient with chronic non-specific neck pain" was conducted. Chronic neck pain patients were divided into two groups, one of them received endurance training and the other group received proprioceptive training. This study suggested that endurance exercise was a more efficient method for improving endurance and Proprioceptive training was better in resolving joint position error and Pain. Both protocol appeared to be useful in treating patients with chronic non specific neck pain. Cervicogenic headache is getting common in young adults along with proprioception deficit in the cervical region. In this study, 30 participants of Cervicogenic headache were included. The control group received stretching exercises. The experimental group in addition to stretching received cervical stabilization exercises. Headache disability index and neck proprioception were evaluated before and after the treatment programs. At the end of 4rth week, Headache disability index scores and neck pain and proprioception error improved more in the experimental group. Hence the study concluded that Cervical stabilization exercises along with stretching are more effective in improving neck proprioception and Headache disability index than stretching alone. The presence of strong coupling between gaze orientation and muscle neck activity has been well documented in humans. This co-ordination between neck motor functions and eye strongly suggest that eye head coupling based rehabilitation program are more appropriate to improve neck proprioception and this afterwards aid in reducing pain. A comparison was done between two groups of neck pain patients one of them receiving the traditional physiotherapy protocol for chronic neck pain and the experimental group received an eye head coupling based rehabilitation program modified from Revel et al., in addition to the traditional protocol given to the other group. The results showed a significant reduction in scores of Neck Pain and Disability scale in both groups with a greater decrease in the experimental subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
chronin non traumatic neck pain, Joint position error, Cervical Proprioception, NDI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random allocation will be done through toss coin method into two groups; Conventional Physiotherapy Control group (n=22) and Proprioceptive training Experimental group (n=22).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
It Includes the TENS, Infrared, Isometric and stretching exercises along with the home plan and postural education. It also include the cervical proprioceptive training
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
TENS for 15 minutes on Constant Mode according to patient comfort. Infrared for 15 minutes. Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement. Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius & Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds. Home Plan: self stretches and isometrics. Postural Education: posture correction in daily life activities in sitting, walking, lying.
Intervention Type
Other
Intervention Name(s)
Cervical proprioceptive training
Intervention Description
TENS for 15 minutes on Constant Mode according to patient comfort. Infrared for 15 minutes. Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement. Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius & Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds. Home Plan: self stretches and isometrics. Postural Education: posture correction in daily life activities in sitting, walking, lying. The patients wearing a cap with a laser pointer attached to it were seated three feet away from the target A, B and C. Start Chart A with a 3 cm, chart B 2cm and chart C 1cm narrow pathway were presented to the patients. The time taken by the patient to complete the pathway without any error was noted.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in patients. The NPRS is a numeric version of the visual analog scale (VAS) in which patient selects a number (0-10) from a horizontal line that best depict the intensity of their pain. 0 represents no pain and 10 represents pain as bad as one can imagine.
Time Frame
2 weeks
Title
Neck Disability Index
Description
NDI is the most widely used instrument for assessing self rated disability in patients with neck pain. It has a total of 10 sections of the following domain: Pain intensity, personal care, carrying weights, reading, headaches, concentration, work, driving, sleep disturbances and recreational activities. Each of the 10 items is scored from 0 (No disability) to 5 (Complete disability).
Time Frame
2 weeks
Title
Range of Motion
Description
Range of motion is a movement potential of a joint in which it moves in its possible availble range. For cervical spine active movements of the neck were recorded in sitting postion. Universal goniometer was used to measure patient's active flexion, extension, Left and right side bendings, left and right side rotations.
Time Frame
2 weeks
Title
Cervical Proprioception
Description
The treatment protocol used for the patients in experimental group was also used as an outcome measurement tool in this study. Patient's cervical proprioception was measured through a procedure adapted by Clark's Joint position error testing. Patients proprioception was assessed on day one and on the last day of their treatment.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mechanical neck pain of Chronic duration (Symptoms present form more than 3 months) Limitation of cervical ROM Age 18-55 Men and Women Exclusion Criteria: Sharp purser test positive Vertebral artery insufficiency test positive Neck pain due to: Inflammatory conditions - infections, ankylosing spondylitis, juvenile arthritis, rheumatoid arthritis and polymyalgia rheumatica. Metabolic - osteoporosis, osteomalacia, Paget's disease, gout. Neoplastic - metastases, myeloma, intrathecal tumours. Referred pain as a result of - angina pectoris, aortic aneurysm, pancoast tumour, diaphragmatic pathology, pharyngial pathology Neck injury due to trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqra Raja, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Government Polyclinic Hospital, Islamabad.
City
Islamabad
State/Province
Capital
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Effects of Cervical Proprioceptive Training in CMNP

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