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NCT Number: NCT04173143

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

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.

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Key information

Conditions

Mechanical Neck Pain

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pakistan Railway hospital

Rawalpindi, Punjab Province, 40100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Craniocervical flexion training with pressure biofeedback

Device

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

Craniocervical flexion training without pressure biofeedback

Other

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 outcomes

  1. Numeric pain rating scale (NPRS)

    Time frame: Baseline

    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.

  2. Numeric pain rating scale (NPRS)

    Time frame: Post 4 week

    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.

  3. Numeric pain rating scale (NPRS)

    Time frame: Post 6 week

    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.

  4. CROM-Flexion

    Time frame: Baseline

    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.

  5. CROM-Flexion

    Time frame: Post 4 week

    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.

  6. CROM-Flexion

    Time frame: Post 6th Week

    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.

  7. CROM-Extention

    Time frame: Baseline

    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.

  8. CROM-Extention

    Time frame: Post 4th Week

    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.

  9. CROM-Extention

    Time frame: Post 6th Week

    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.

  10. Deep neck Flexor endurance

    Time frame: Baseline

    Deep neck flexor endurance test: (Clinical test of endurance for control group)

  11. Deep neck Flexor endurance

    Time frame: Post 4th Week

    Deep neck flexor endurance test: (Clinical test of endurance for control group)

  12. Deep neck Flexor endurance

    Time frame: Post 6th Week

    Deep neck flexor endurance test: (Clinical test of endurance for control group)

  13. Craniocervical flexion test (Clinical test of endurance for experimental group)

    Time frame: Baseline

    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.

  14. Craniocervical flexion test (Clinical test of endurance for experimental group)

    Time frame: Post 4th week

    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.

  15. Craniocervical flexion test (Clinical test of endurance for experimental group)

    Time frame: Post 6th week

    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 outcomes

  1. Cranio-vertebral angle

    Time frame: Baseline

    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.

  2. Cranio-vertebral angle

    Time frame: Post 4th week

    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.

  3. Cranio-vertebral angle

    Time frame: Post 6th week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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