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Effect of Proprioceptive Training Using Head Mounted Laser in Chronic Mechanical Neck Pain

Primary Purpose

Mechanical Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive training using head mounted laser
Conventional Physical therpay
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring proprioception, joint position sense error, head mounted laser, cervical range of motion

Eligibility Criteria

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

Inclusion Criteria: Both genders Age: 45 to 55 years Mechanical neck pain more than 3 months (chronic stage) Individuals having cervical radiculopathy (Spurling Test A and Spurling test B +ve) Decreased Range of motion (Flexion 80 to 90*) (Extension 70*) (Lateral Flexion 20 TO 45*) (Rotation 90*) Numeric Pain Rating Scale: 5 to 08 Cervical spondylosis on Xray Exclusion Criteria: Individuals having vascular pathology of neck. Previous surgery related to cervical spine. Individuals having structural deformity of spine (Adam's forward bend test) Spinal Cord Injury /Cervical Myelopathy Malignancy and tumor Infection Previous history of Cervical spine fractures

Sites / Locations

  • Shifa Tameer-e-Millat University IslamabadRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental Group

Control Group

Arm Description

Conventional physical therapy along with proprioceptive training, head relocation practice that is relocating the head back to the natural head posture and to pre determined postions in range with eyes open. Tracing figure of eight with eyes open. 3 days per week for 4 weeks, 15 repititions, 1 set.

Conventional physical therapy, cervical range of motion (flexion, extension, lateral flexion and rotation), isometric exercises of neck muscles, stretching (scalene, trapezius, sternocleidomastoid), TENS, heating pad. 3 days per week for 4 weeks, 15 repitions, 1 set.

Outcomes

Primary Outcome Measures

cervical joint position sense error
use for assess proprioception
bubble inclinometer
use to assess cervical range of motion
numerical pain rating scale
used for assessment of pain
neck disability index
used for pain related disability

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
September 5, 2023
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT06034223
Brief Title
Effect of Proprioceptive Training Using Head Mounted Laser in Chronic Mechanical Neck Pain
Official Title
Effect of Proprioceptive Training Using Head Mounted Laser in Chronic Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

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
The purpose of this study is to compare the effect of conventional physical therapy with and without cervical proprioceptive training using head mounted laser system on cervical joint position sense error, pain, cervical range of motion and neck disability index. Proprioception disturbs in any function and structural impairments that is mechanical neck pain. Different studies has been done to find out the best therapy for pain management. our aim is to give cost effective, not so time consuming, most effective physcial therapy treatment. A literature gap exists on the effects of proprioceptive training combined with conventional physical therapy, no studies have directly compared the effect of proprioceptive training using head mounted laser with and without conventional physical therapy. In our clinical setting, proprioceptive training for mechanical neck pain is not used as much as it should be. It would be a new thing to add and it can be cost effective and better treatment for symptoms resolution
Detailed Description
Mechanical neck pain (MNP) is a common condition, affecting 30% to 50% of the general population, and is most prevalent in middle age. It is responsible for reducing the quality of life and one of the leading causes of disability worldwide with annual prevalence of 48.5%. Mechanical neck pain is characterized by several structural and functional features. The causes of MNP include structural and functional impairment of cervical muscles, degenerative changes of cervical spine, arthritis, inflammation, and trauma, abnormal posture, and movements. Current studies have found that one of the main problems in patients with MNP is the impairment of cervical proprioception. decreased range of motion (ROM) and functional ability, greater muscle fatigability and a reduction in the strength and endurance capacity of the muscles. In spite of neck disorders being so common in the population, little evidence supporting effective interventions has been identified. Conservative treatments used to help manage MNP are numerous and include usual medical care various forms of exercise, massage, and acupuncture. Medications, manual therapies, and exercise are the most widely used treatment modalities for MNP. 33% of individuals with neck pain sought care from physical therapy. Physical therapy improves pain, function and patient satisfaction in adults suffering from MNP, improves neck disability index. Physical therapy treatment includes cervical and thoracic spine mobilization/manipulation techniques active and passive exercise, ultrasound, transcutaneous electrical nerve stimulation, patient education. Spinal manipulative therapy (SMT), trigger point dry needling and trigger point manual therapy. Proprioception is the sense of perceiving self-movement, action of parts of the body and location. It is a term commonly used to describe the ascending information by the afferent receptors towards the central nervous system contributing to the neuromuscular control of movement and encompasses the sensation of joint movement (kinaesthesia) and joint position (joint position sense). Cervical spine has a very delicate proprioceptive system, which signals the position of the head relative to the trunk, coordinates the vestibular and visual systems and it plays a crucial role in controlling posture and balance and is of great importance for the spatial orientation. The deficits of Proprioception of cervical spine have been associated with age, pain muscle fatigue, forward head posture, cervical spondylosis, reduce balance control and abnormal posture, decreased neck muscle strength and altered motor control in the cervical spine. In last two decades the interest in the assessment and treatment of proprioception of the cervical spine has increased exponentially. Cervical joint position sense (JPS) is a major component of proprioception, and mainly reflects the ascending input (afferent) of cervical muscle, disc, capsule, and ligament receptors. Proprioception is evaluated using the Joint Position Sense Error (JPSE), which reflects a person's ability to accurately return his head to a predefined target after a cervical movement. Evidence to date suggests that the management of sensorimotor control disturbances due to chronic neck pain may need to address the primary causes and secondary effects of alterations in proprioceptive activity. A variety of treatments are available for cervical spine proprioception. It includes proprioception training, retraining of deep cervical flexor and extensor muscles, and etiological management of pain, strength training, cervical manipulation and acupuncture and many other conventional therapy protocols. Cervical proprioception training not only improves patient perceived pain and disability, but also has an effect on other aspects of neuromuscular function, specifically the coordination between the deep and superficial cervical flexors and balance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
proprioception, joint position sense error, head mounted laser, cervical range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
the participants are divided into two groups, control group will recieve conventional physical therapy and experimental group will recieve proprioceptive training with conventional physcial therapy.
Masking
Participant
Masking Description
It is a single blinded study in which participants will be alocated in two groups using simple random sampling.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Conventional physical therapy along with proprioceptive training, head relocation practice that is relocating the head back to the natural head posture and to pre determined postions in range with eyes open. Tracing figure of eight with eyes open. 3 days per week for 4 weeks, 15 repititions, 1 set.
Arm Title
Control Group
Arm Type
Other
Arm Description
Conventional physical therapy, cervical range of motion (flexion, extension, lateral flexion and rotation), isometric exercises of neck muscles, stretching (scalene, trapezius, sternocleidomastoid), TENS, heating pad. 3 days per week for 4 weeks, 15 repitions, 1 set.
Intervention Type
Other
Intervention Name(s)
Proprioceptive training using head mounted laser
Intervention Description
Exercises include head relocation practice, i.e., relocating the head back to the natural head posture and to pre-determined positions in range with eyes open using feedback from a laser attached to their head. And then tracing the figure of eight with the help of laser.
Intervention Type
Other
Intervention Name(s)
Conventional Physical therpay
Intervention Description
Conventional physical therapy for mechanical neck pain which includes cervical range of motion (flexion, extension, lateral rotation, and rotation), neck isometric exercises, stretching's (scalene, trapezius, SCM) and TENS with heating pad.
Primary Outcome Measure Information:
Title
cervical joint position sense error
Description
use for assess proprioception
Time Frame
4 weeks
Title
bubble inclinometer
Description
use to assess cervical range of motion
Time Frame
4 weeks
Title
numerical pain rating scale
Description
used for assessment of pain
Time Frame
4 weeks
Title
neck disability index
Description
used for pain related disability
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders Age: 45 to 55 years Mechanical neck pain more than 3 months (chronic stage) Individuals having cervical radiculopathy (Spurling Test A and Spurling test B +ve) Decreased Range of motion (Flexion 80 to 90*) (Extension 70*) (Lateral Flexion 20 TO 45*) (Rotation 90*) Numeric Pain Rating Scale: 5 to 08 Cervical spondylosis on Xray Exclusion Criteria: Individuals having vascular pathology of neck. Previous surgery related to cervical spine. Individuals having structural deformity of spine (Adam's forward bend test) Spinal Cord Injury /Cervical Myelopathy Malignancy and tumor Infection Previous history of Cervical spine fractures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syed Ali Hussain, PhD*
Phone
03315191713
Email
alihussain_dpt.ahs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nida Waseem, MS-PT*
Organizational Affiliation
Shifa Tameer-e-millet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa Tameer-e-Millat University Islamabad
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manan Haider
Phone
+923334839819
Email
m_manan.drs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
nida Waseem, MS-PT*

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Effect of Proprioceptive Training Using Head Mounted Laser in Chronic Mechanical Neck Pain

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