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

November 10, 2023 updated by: Riphah International University

Comparative Effects of Modified Cervical Retraction and Motor Control Therapeutics Exercises on Pain, Range of Motion and Functional Disability in Patients With Cervical Spondylosis

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

Study Overview

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

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Riphah Rehabilitation Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: : Modified Cervical Retraction Exercises (MCRE)
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
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
Experimental: Motor Control therapeutic exercise(MCTE)
The MCTE will used is based on retraining the cervical muscles and included four exercises
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
. Numerical Rating Scale (NPRS)
Time Frame: 6th week
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)
6th week
Neck Disability Index (NDI)
Time Frame: 6th weeks
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
6th weeks
Handheld dynamometry (HHD)
Time Frame: 6th weeks
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
6th weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROM cervical spine (flexion)
Time Frame: 6th weeks
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
6th weeks
ROM cervical spine (extension)
Time Frame: 6th weeks

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

6th weeks
ROM cervical spine (side flexion)
Time Frame: 6th weeks
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
6th weeks
ROM cervical spine (Rotation)
Time Frame: 6th weeks
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
6th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sana hafeez, phD*, Riphah International University Lahore Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2023

Primary Completion (Actual)

September 28, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 14, 2023

First Posted (Actual)

June 23, 2023

Study Record Updates

Last Update Posted (Actual)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • : REC/RCR & AHS/23/0123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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