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Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Mechanical Neck Pain

Primary Purpose

Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Craniocervical flexion training with pressure biofeedback
Craniocervical flexion training without pressure biofeedback
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 endurance training,

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients with Chronic mechanical neck pain for more than 3 months duration

    • subjects with aged 25-40 years
    • Numeric pain rating scale (NRPS) greater than 3.
    • Patients with Forward neck posture and a Craniovertebral angle less than 48°

Exclusion Criteria:

  • • History of neck surgery, cervical trauma Spinal cord compression, Spinal tumor, Spinal instability

    • History of Spinal fracture, inflammatory disease of spine, Spinal infections, significant neurological deficit, Congenital or acquired postural deformity, doing prescribed exercise for cervical spine.
    • Neck or shoulder pain from non-musculoskeletal causes, demonstrated neurological signs, or had a history of malignancy, current pregnancy.

Sites / Locations

  • Pakistan Railway hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

This group will receive Cranio cervical flexion training with pressure biofeedback protocol.

This group will receive Cranio cervical flexion training without pressure biofeedback protocol

Outcomes

Primary Outcome Measures

Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Numeric pain rating scale (NPRS)
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Flexion
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
CROM-Extention
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Deep neck Flexor endurance
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Craniocervical flexion test (Clinical test of endurance for experimental group)
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.

Secondary Outcome Measures

Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Cranio-vertebral angle
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.

Full Information

First Posted
November 20, 2019
Last Updated
January 17, 2020
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04173143
Brief Title
Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Mechanical Neck Pain
Official Title
Effects of Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Patients With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 31, 2019 (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
The superficial neck flexor musculature has been given considerate amount of attention to explore its effects on the cervical pain in several researches.. This study intends to put through the benefits of deep cervical flexor training for treatment of cervical neck pain patients.This study will also compare the effects of Cranio cervical flexion training with and without pressure biofeedback on neck pain, muscular endurance,forward head posture and cervical mobility in mechanical neck pain.
Detailed Description
The study is Randomized Control Trail, which is being conducted in physical therapy Outpatient department of Pakistan Railway hospital. Sample size of 24 individual was calculated using Epitool with 95% confidence interval (CI) and power 80%. Individual will be screened out according to inclusion criteria. Individuals will be allocated randomly into two groups, 12 in Craniocervical flexion training with pressure biofeedbackgroup and 12 in Craniocervical flexion training without pressure biofeedbackgroup by sealed envelope method. Deep neck flexor endurance techniquewas used totrain theCraniocervical flexor muscles in control group.Craniocervical flexion technique with Pressure biofeedback unit's was positioned behind the neck just below the occiput was used to train the endurance of the Craniocervical flexor muscle in experimental group. Assessment will be done on baseline and 4th week. Data will be analyzed on SPSS version 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Neck Pain
Keywords
endurance training,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both experimental and control groups will be treated simultaneously with different modes of endurance training
Masking
Participant
Masking Description
This study will be single blinded randomized control trail, participants will be unaware of treatment groups, they will be randomly allocated through sealed envelope method.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
This group will receive Cranio cervical flexion training with pressure biofeedback protocol.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
This group will receive Cranio cervical flexion training without pressure biofeedback protocol
Intervention Type
Device
Intervention Name(s)
Craniocervical flexion training with pressure biofeedback
Intervention Description
Total 15 patients participated in this training group. Session was performed thrice in a week. Each session was givenfor approximately 20minutesPatients were asked to lie in supine hook lying position. After that Pressure biofeedback unit's air bag was clipped together and folded in three and positioned behind the neck just below the occiput. Patients were advised to perform Craniocervical flexion and practiced head nodding action to progressively target (reach the incremental targets) and hold the 5 pressure levels for 10 second between 22 mm Hg and 30 mmHg. A 2 minute second rest period was provided between each level. Minimum performance requirement was 26 mm Hg while ideal performance targets are 28 and 30 mm Hg... Patient will be re-assessed for all baseline variables after 4 weeks of training
Intervention Type
Other
Intervention Name(s)
Craniocervical flexion training without pressure biofeedback
Intervention Description
Total 15 patients participated in this control group.Session was given 3 times in a week. Each session continue forapproximately 20 minutes. The patient lies in supine crook lying position. The patientwas maximally retracted the chin and asked to maintained it while the patient lifts the head and neck until the head is relatively 2 to 5 cm (1 inch) abovethe couch. The examiner places a hand under the head of patient on the table. Patients were instructed to perform10 repetitions for a hold of 20 seconds initially, increasing it by 10 seconds progressively.The entire session had a maximum of 4 sets. Patient will be re-assessed for all baseline variables after 4 weeks of training
Primary Outcome Measure Information:
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Time Frame
Baseline
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Time Frame
Post 4 week
Title
Numeric pain rating scale (NPRS)
Description
Numeric pain rating scale (NPRS) is an 11 point (0-10) Scale used to measure pain. Patient verbally select value between (0-10) on the basis of intensity of pain. (0) means No pain and (10) means maximum pain experienced at baseline.
Time Frame
Post 6 week
Title
CROM-Flexion
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Baseline
Title
CROM-Flexion
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Post 4 week
Title
CROM-Flexion
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Post 6th Week
Title
CROM-Extention
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Baseline
Title
CROM-Extention
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Post 4th Week
Title
CROM-Extention
Description
A cervical range of motion (CROM) goniometer will be used to assess cervical range of motion in flexion, extension. Participants will be seated upright and asked to actively move their neck in each direction.
Time Frame
Post 6th Week
Title
Deep neck Flexor endurance
Description
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Time Frame
Baseline
Title
Deep neck Flexor endurance
Description
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Time Frame
Post 4th Week
Title
Deep neck Flexor endurance
Description
Deep neck flexor endurance test: (Clinical test of endurance for control group)
Time Frame
Post 6th Week
Title
Craniocervical flexion test (Clinical test of endurance for experimental group)
Description
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Time Frame
Baseline
Title
Craniocervical flexion test (Clinical test of endurance for experimental group)
Description
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Time Frame
Post 4th week
Title
Craniocervical flexion test (Clinical test of endurance for experimental group)
Description
The cranio cervical flexion test (CCFT) is used to assess endurance of the deep cervical flexors. A pressure biofeedback unit is inflated to 20 mmHg and is placed behind the neck. While keeping the back of the head stable, the patient performs cranial cervical flexion in a graded fashion in 5 increments (22, 24, 26, 28, and 30 mmHg). Each position is held for 10 seconds with 10 seconds rest between increments.. The test is ended when the pressure decreases >20% or when substitution occurs during the head nod.
Time Frame
Post 6th week
Secondary Outcome Measure Information:
Title
Cranio-vertebral angle
Description
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Time Frame
Baseline
Title
Cranio-vertebral angle
Description
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Time Frame
Post 4th week
Title
Cranio-vertebral angle
Description
On protractor tool was used to measure forward head posture through a craniovertebral angle (CVA).. It has excellent reliability value (ICC 0.991).Participants were asked to sit on a stool and concentrate at a specific point on their eye level.Then we used three markers: one on C7, the other on tragus and the third on canthus. The angle between the line connecting C7 to tragus and a vertical line extending from C7 was calculated and images were taken. Patients having a Craniovertebral angle less than 48°were considered in category of forward head posture.
Time Frame
Post 6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients with Chronic mechanical neck pain for more than 3 months duration subjects with aged 25-40 years Numeric pain rating scale (NRPS) greater than 3. Patients with Forward neck posture and a Craniovertebral angle less than 48° Exclusion Criteria: • History of neck surgery, cervical trauma Spinal cord compression, Spinal tumor, Spinal instability History of Spinal fracture, inflammatory disease of spine, Spinal infections, significant neurological deficit, Congenital or acquired postural deformity, doing prescribed exercise for cervical spine. Neck or shoulder pain from non-musculoskeletal causes, demonstrated neurological signs, or had a history of malignancy, current pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
40100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24298492
Citation
Gupta BD, Aggarwal S, Gupta B, Gupta M, Gupta N. Effect of Deep Cervical Flexor Training vs. Conventional Isometric Training on Forward Head Posture, Pain, Neck Disability Index In Dentists Suffering from Chronic Neck Pain. J Clin Diagn Res. 2013 Oct;7(10):2261-4. doi: 10.7860/JCDR/2013/6072.3487. Epub 2013 Oct 5.
Results Reference
background
PubMed Identifier
26957772
Citation
Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016 Jan;28(1):269-73. doi: 10.1589/jpts.28.269. Epub 2016 Jan 30.
Results Reference
background
PubMed Identifier
26644676
Citation
Kang DY. Deep cervical flexor training with a pressure biofeedback unit is an effective method for maintaining neck mobility and muscular endurance in college students with forward head posture. J Phys Ther Sci. 2015 Oct;27(10):3207-10. doi: 10.1589/jpts.27.3207. Epub 2015 Oct 30.
Results Reference
background
PubMed Identifier
24259822
Citation
Iqbal ZA, Rajan R, Khan SA, Alghadir AH. Effect of deep cervical flexor muscles training using pressure biofeedback on pain and disability of school teachers with neck pain. J Phys Ther Sci. 2013 Jun;25(6):657-61. doi: 10.1589/jpts.25.657. Epub 2013 Jul 23.
Results Reference
background
PubMed Identifier
30881101
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.
Results Reference
background

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Cranio- Cervical Flexion Training With and Without Pressure Biofeedback in Mechanical Neck Pain

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