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Effects Of Deep Neck Flexor And Extensor Exercises

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Deep Neck Flexors & Extensors exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mechanical Neck Pain focused on measuring Neck muscles, Neck Pain, Muscle strength, Range of Motion

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Males and Females 18 and 40 years of age Forward Head Posture Manual Muscle testing (MMT) grade less than 6 Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds Exclusion Criteria: Cervical radiculopathy History of whiplash injury History of cervical and thoracic spine surgery Neck pain associated with vertigo History of spinal osteoporosis Vertebral Fractures Tumors Diagnosed psychological disorders

Sites / Locations

  • Riphah Rehabilitation Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A: Deep Neck Flexors & Extensors exercises

Group B: Standardized Physical Therapy

Arm Description

Group A Patients will receive: Deep neck flexor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,

Standardized Physiotherapy treatment will be: Hot pack for 10 minutes, SNAG manual therapy at Cervical spine 6 repetitions for 60 seconds. Superficial neck muscles (upper trapezius, Levator scapulae, Pect.Major) stretching for 3 times with 30 seconds and Neck isometrics 10 times with 6 seconds hold. Both groups will come thrice per week for a total of 4 weeks. Pre and post treatment values of both groups will be analyzed

Outcomes

Primary Outcome Measures

Numerical Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; High test-retest reliability has been (r = 0.96 and 0.95, respectively) For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95
Manual Muscle Testing (MMT)
Muscle strength will be assessed by Manual muscle testing. Which is scored using a 0-5 points Medical Research Council muscle strength scale. MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.
Universal Goniometer (UG)
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error. The range of motion of neck including flexion and extension will be measured by using universal goniometer that has an inter-rater reliability (ICC2, 2 = 0.79 to 0.92) for cervicle region.
Pressure Biofeedback unit
Pressure biofeedback unit if placed under the suboccipital region and the pressure cuff is inflated to a pressure of 20 mmHg in order to fill the space of the cervical lordosis and the subject asked to perform a gentle head-nodding action of craniocervical flexion (indicating yes). Maximum pressure increase above the baseline upto 10 mmHg achieved and held for 10 seconds is defined as strength of deep cervical flexors.

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
February 20, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05618964
Brief Title
Effects Of Deep Neck Flexor And Extensor Exercises
Official Title
Effects Of Deep Neck Flexor And Extensor Exercises On Pain, Range Of Motion And Muscle Strength In Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
January 18, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

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
Deep cervical flexor and extensor muscles show decreased strength in patients with Mechanical neck pain. Exercises involving deep cervical muscles has improved coordination and motor control. This study aim to determine the effects of deep flexor muscle exercises along with deep extensor muscle exercises on pain, range of motion and muscle strength in mechanical neck pain.
Detailed Description
This study will be a randomized controlled trial and will be conducted in Riphah Rehabilitation Clinic Lahore and Physiotherapy outpatient department of WAPDA Teaching Hospital Lahore. Non-probability consecutive sampling will be used to collect the data. Sample size of 36 subjects with age group between 18-40 years will be taken. Data will be collected from the patients having present complaint of Mechanical Neck pain. Outcome measures will be taken using Numeric pain rating scale (NPRS) for pain, Manual Muscle Testing (MMT) for muscle strength and Universal Goniometer (GU) for Range of motion. An informed consent will be taken. Subjects will be selected on the basis of inclusion and exclusion criteria and will be equally divided into two groups by random number generator table. Both the Groups will receive Hot Pack, superficial neck muscles stretching and Neck isometrics, while Group A will receive deep neck flexor and extensor exercises, and Group B will receive conventional treatment. Outcome measures will be measured at baseline and after 4 weeks. Data analysis will be done by SPSS version 25.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
Neck muscles, Neck Pain, Muscle strength, Range of Motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Deep Neck Flexors & Extensors exercises
Arm Type
Experimental
Arm Description
Group A Patients will receive: Deep neck flexor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,
Arm Title
Group B: Standardized Physical Therapy
Arm Type
No Intervention
Arm Description
Standardized Physiotherapy treatment will be: Hot pack for 10 minutes, SNAG manual therapy at Cervical spine 6 repetitions for 60 seconds. Superficial neck muscles (upper trapezius, Levator scapulae, Pect.Major) stretching for 3 times with 30 seconds and Neck isometrics 10 times with 6 seconds hold. Both groups will come thrice per week for a total of 4 weeks. Pre and post treatment values of both groups will be analyzed
Intervention Type
Other
Intervention Name(s)
Deep Neck Flexors & Extensors exercises
Intervention Description
Deep neck flexor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck flexor muscle in supine Craniocervical flexion in supine Deep Neck Extensor exercises (2 set of 10 repetitions) that includes: Contraction of deep neck extensors in quadruped position Segmented extension movement with the head bent down onto their chest in a horizontal direction,
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NPRS)
Description
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain. The NPRS is a segmented numeric version in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). The NPRS takes <1 minute to complete The NPRS is a valid and reliable scale to measure pain intensity; High test-retest reliability has been (r = 0.96 and 0.95, respectively) For construct validity, the NPRS was shown to be highly correlated: correlations range from 0.86 to 0.95
Time Frame
follow up on 4th week
Title
Manual Muscle Testing (MMT)
Description
Muscle strength will be assessed by Manual muscle testing. Which is scored using a 0-5 points Medical Research Council muscle strength scale. MMT is the most commonly used method for documenting impairments in muscle strength in both spine and periphery with a kappa value 0.88.
Time Frame
followup on 4th week
Title
Universal Goniometer (UG)
Description
A goniometer is an instrument that measures the available range of motion at a joint. To measure the range of motion physical therapists most commonly use a goniometer. It is necessary that a single notation system is used in goniometry. The neutral zero method (0 to 180- degree system) is the most widely used method. The same goniometer should always be used to reduce the chances of instrumental error. The range of motion of neck including flexion and extension will be measured by using universal goniometer that has an inter-rater reliability (ICC2, 2 = 0.79 to 0.92) for cervicle region.
Time Frame
follow up on 4th week
Title
Pressure Biofeedback unit
Description
Pressure biofeedback unit if placed under the suboccipital region and the pressure cuff is inflated to a pressure of 20 mmHg in order to fill the space of the cervical lordosis and the subject asked to perform a gentle head-nodding action of craniocervical flexion (indicating yes). Maximum pressure increase above the baseline upto 10 mmHg achieved and held for 10 seconds is defined as strength of deep cervical flexors.
Time Frame
follow up on 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and Females 18 and 40 years of age Forward Head Posture Manual Muscle testing (MMT) grade less than 6 Deep Flexor strength measured by pressure biofeedback unit (20 mmHg), patients who cannot hold craniocervical flexion (indicating yes) for 10 seconds Exclusion Criteria: Cervical radiculopathy History of whiplash injury History of cervical and thoracic spine surgery Neck pain associated with vertigo History of spinal osteoporosis Vertebral Fractures Tumors Diagnosed psychological disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphil
Organizational Affiliation
Riphah International University,Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34980079
Citation
Kazeminasab S, Nejadghaderi SA, Amiri P, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Neck pain: global epidemiology, trends and risk factors. BMC Musculoskelet Disord. 2022 Jan 3;23(1):26. doi: 10.1186/s12891-021-04957-4.
Results Reference
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Fandim JV, Nitzsche R, Michaleff ZA, Pena Costa LO, Saragiotto B. The contemporary management of neck pain in adults. Pain Manag. 2021 Jan;11(1):75-87. doi: 10.2217/pmt-2020-0046. Epub 2020 Nov 25.
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Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.
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Citation
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Rodriguez-Sanz J, Malo-Urries M, Lucha-Lopez MO, Lopez-de-Celis C, Perez-Bellmunt A, Corral-de-Toro J, Hidalgo-Garcia C. Comparison of an exercise program with and without manual therapy for patients with chronic neck pain and upper cervical rotation restriction. Randomized controlled trial. PeerJ. 2021 Nov 24;9:e12546. doi: 10.7717/peerj.12546. eCollection 2021.
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Citation
Suvarnnato T, Puntumetakul R, Uthaikhup S, Boucaut R. Effect of specific deep cervical muscle exercises on functional disability, pain intensity, craniovertebral angle, and neck-muscle strength in chronic mechanical neck pain: a randomized controlled trial. J Pain Res. 2019 Mar 7;12:915-925. doi: 10.2147/JPR.S190125. eCollection 2019.
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Alghadir AH, Iqbal ZA. Effect of Deep Cervical Flexor Muscle Training Using Pressure Biofeedback on Pain and Forward Head Posture in School Teachers with Neck Pain: An Observational Study. Biomed Res Int. 2021 May 22;2021:5588580. doi: 10.1155/2021/5588580. eCollection 2021.
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Effects Of Deep Neck Flexor And Extensor Exercises

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