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Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis

Primary Purpose

Cervical Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Modified Cervical Retraction Exercises (MCRE)
Motor Control therapeutic exercise(MCTE)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 45 -65 years Both. male and female, Patient with pain NPRS 4-7 Subject radiological diagnosed Cervical spondylosis (With or without Radiculopathy Exclusion Criteria: Cervical fracture or injury Cervical spine osteoporosis, Cervical myelopathy & Cervical canal stenosis, Cervical Malignancy

Sites / Locations

  • Riphah Rehabilitation ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

: Modified Cervical Retraction Exercises (MCRE)

Motor Control therapeutic exercise(MCTE)

Arm Description

The patient is in sitting OR standing position and faces the physical therapist. The MCRE program consisted of alternating head positions. Hold each position for 20 sec with 8 to 10 repetitions

The MCTE will used is based on retraining the cervical muscles and included four exercises

Outcomes

Primary Outcome Measures

. Numerical Rating Scale (NPRS)
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Neck Disability Index (NDI)
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80
Handheld dynamometry (HHD)
A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction. The device can be used to test both proximal and distal muscles in all extremities. Specific dynamometers are used to test grip strength. The Strength measure is more sensitive to change than MMT and correlates well with fixed dynamometry up to 30-kg force. Reliability coefficients for HHD ranged from -0.19 to 0.99, with the majority surpassing 0.70. HHD readings obtained by multiple raters may be up to 53% more variable than those obtained by a single rater

Secondary Outcome Measures

ROM cervical spine (flexion)
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion
ROM cervical spine (extension)
the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM. [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and pati
ROM cervical spine (side flexion)
the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for sid
ROM cervical spine (Rotation)
the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM

Full Information

First Posted
June 14, 2023
Last Updated
June 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05916794
Brief Title
Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis
Official Title
Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises on Pain, Range of Motion and Functional Disability in Patients With Cervical Spondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 8, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International 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
Cervical spondylosis is a general term for age-related wear and tear in the cervical spine that can lead to neck pain, stiffness and other symptoms. Sometimes this condition is called arthritis or osteoarthritis of the neck. The spine likely begins this wearing-down process sometime in your 30s. By age 60, almost nine in 10 people have cervical spondylosis .Objective of this study is to compare the effects of Modified cervical retraction Motor control therapeutic exercises on pain, ROM and functional disability in patients with cervical spondylosis
Detailed Description
Cervical spondylosis is a chronic degenerative process of the cervical spine which affects the vertebral bodies and intervertebral discs and causes herniated intervertebral discs, osteophytes, and ligament hypertrophy. It is commonly seen in patients between the ages of 40 and 60. Neck pain not only imposes a notable burden on individuals in the society, but also affects families, the healthcare and economic systems of countries. In 2017, age-standardized prevalence, annual incidence, and years lived with disability from neck pain were estimated at 3551, 807, and 352 per 100,000 population worldwide, respectively Patients seeking medical help for this condition primarily complain of neck pain and/or stiffness. This pain is considered the second most common complaint post low back pain and increased by neck movements especially hyperextension and side bending Currently, there are several therapeutic approaches, either pain relievers or non-medicinal treatments for the management of cervical spondylosis and its associated pain and disability Pain medications mainly include non-steroids anti-inflammatory drugs and narcotics with exercise therapy, massage, physiotherapy, and local injections are among the most common non-medicinal therapies. Evidence suggests that exercise therapy plays a role in improving neck pain and disability of patients with cervical spondylosis. Besides, thanks to being non-invasive and profitable, exercise therapy is commonly used in patient rehabilitation Therapeutic exercises include various workouts such as proprioceptive exercises, stability exercises, strength exercises (dynamic and isometric) and endurance exercises. Neck retraction helps recover the lordotic curve in the lower cervical portion, but kyphotic changes may occur at the upper cervical level. The motor control exercises are the therapeutic approach which mainly focuses on motor control, activation of deep cervical muscles, and aims to retrain the optimal control and coordination of the cervical muscles Apart from the fact that clinical guidelines suggest therapeutic exercises as an integral part of managing neck pain and disability, prescribing the most advantageous exercise therapy has yet been controversial and even current guidelines do not offer specific recommendations on the preferred type and dosage of exercises

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
: Modified Cervical Retraction Exercises (MCRE)
Arm Type
Experimental
Arm Description
The patient is in sitting OR standing position and faces the physical therapist. The MCRE program consisted of alternating head positions. Hold each position for 20 sec with 8 to 10 repetitions
Arm Title
Motor Control therapeutic exercise(MCTE)
Arm Type
Experimental
Arm Description
The MCTE will used is based on retraining the cervical muscles and included four exercises
Intervention Type
Other
Intervention Name(s)
Modified Cervical Retraction Exercises (MCRE)
Intervention Description
Group A includes Modified cervical retraction exercise The patient is in sitting OR standing position and faces the physical therapist. The MCRE program consisted of alternating head position( neutral, side bending and rotation) while pushing their chin backward patients maintained an upright posture and tried to pull back their shoulders while maintaining this retracted position patient side bend OR rotate their head respectively hold the position for 20 sec.subject performed 5 sets of 10 repetition for 3-4 days per week. Rest intervals of 30 seconds were provided after the completion of 10 repetitions for each pattern and between sets, respectively. The total duration of MCRE will be of approximately 15-20 minutes
Intervention Type
Other
Intervention Name(s)
Motor Control therapeutic exercise(MCTE)
Intervention Description
Motor control therapeutic exercises will be guided for the retraining of cervical muscles.it include craniocervical flexor exercise,craniocervical extensor exercise, co-contraction of flexors and extensor, a synergy exercise for retraining the strength of the deep neck flexors. Each of these four exercises will be performed for 3 sets of 8 to 10 repetitions, taking an approximate total duration of 15-20 minutes for, 3 days a week
Primary Outcome Measure Information:
Title
. Numerical Rating Scale (NPRS)
Description
Numeric Rating Scale (NPRS) is most frequently used instruments to measure pain intensity in neck pain .The 11-point numeric with 0 representing No pain, 1-3 representing Mild Pain (nagging, annoying, interfering little with ADLs), 4-6 representing Moderate Pains (interferes significantly with ADLs), 7-10 representing Sever Pain (disabling, unable to perform ADLs)
Time Frame
6th week
Title
Neck Disability Index (NDI)
Description
The NDI can be scored as a raw score or doubled and expressed as a percent. Each section is scored on a 0 to 5 rating scale, in which zero means 'No pain' and 5 means 'Worst imaginable pain. Points summed to a total score The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage.,0 points or 0% means : no activity limitations .50 points or 100% means complete activity limitation. A higher score indicates more patient-rated disability. For patients' understanding, the URDU version is used. A clinically important change was calculated as 5 points, with a sensitivity of 0.78 and a specificity of 0.80
Time Frame
6th weeks
Title
Handheld dynamometry (HHD)
Description
A small portable device is held by the examiner and placed against the patient's limb during a maximal isometric contraction. The device can be used to test both proximal and distal muscles in all extremities. Specific dynamometers are used to test grip strength. The Strength measure is more sensitive to change than MMT and correlates well with fixed dynamometry up to 30-kg force. Reliability coefficients for HHD ranged from -0.19 to 0.99, with the majority surpassing 0.70. HHD readings obtained by multiple raters may be up to 53% more variable than those obtained by a single rater
Time Frame
6th weeks
Secondary Outcome Measure Information:
Title
ROM cervical spine (flexion)
Description
The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor for measuring range of cervical flexion
Time Frame
6th weeks
Title
ROM cervical spine (extension)
Description
the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and patient extend neck, for measuring the cervical extension ROM. [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed over the external auditory meatus, proximal arm is Perpendicular or parallel to ground and distal arm With base of nares or parallel to longitudinal axis of tongue depressor and pati
Time Frame
6th weeks
Title
ROM cervical spine (side flexion)
Description
the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for side flexion [Time Frame: 6th week] The patient is seated with upper back supported with chair the center of goniometer is placed Over spinous process of C7,proximal arm over Spinous processes of thoracic vertebrae so that arm is perpendicular to ground and distal arm place over Dorsal midline of head. Reference occipital protuberance for sid
Time Frame
6th weeks
Title
ROM cervical spine (Rotation)
Description
the center of the goniometer is placed Over center of cranial aspect of head, proximal arm is placed Parallel to imaginary line between the two acromial processes and distal arm With the tip of the nose. If using the tongue depressor, parallel to the longitudinal axis of tongue depressor for cervical rotation ROM
Time Frame
6th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 45 -65 years Both. male and female, Patient with pain NPRS 4-7 Subject radiological diagnosed Cervical spondylosis (With or without Radiculopathy Exclusion Criteria: Cervical fracture or injury Cervical spine osteoporosis, Cervical myelopathy & Cervical canal stenosis, Cervical Malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sana hafeez, phD*
Phone
03234195603
Email
Sana.hafeez@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Zafar, MS
Phone
03228418395
Email
Ayishahzafar027@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sana hafeez, phD*
Organizational Affiliation
Riphah International University Lahore Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Zafar, DPT
First Name & Middle Initial & Last Name & Degree
SANA HAFEEZ, PhD*
Phone
03314545667

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises in Cervical Spondylosis

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