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

NCT04173143 | Completed

• 1 other identifier: RiphahIU Rabia Ashfaq
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Neck Pain

Keywords

endurance training,

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  Post 4 week

• 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.

  Post 6 week

• 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.

  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.

  Post 4 week

• 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.

  Post 6th Week

• 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.

  Baseline

• 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.

  Post 4th Week

• 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.

  Post 6th Week

• Deep neck Flexor endurance

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

  Baseline

• Deep neck Flexor endurance

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

  Post 4th Week

• Deep neck Flexor endurance

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

  Post 6th Week

• 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.

  Baseline

• 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.

  Post 4th week

• 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.

  Post 6th week

Secondary Outcomes (3)

• Cranio-vertebral angle

  Baseline

• Cranio-vertebral angle

  Post 4th week

• Cranio-vertebral angle

  Post 6th week

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Craniocervical flexion training with pressure biofeedback

Group 2

ACTIVE COMPARATOR

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

Other: Craniocervical flexion training without pressure biofeedback

Interventions

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

Group 1

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

Group 2

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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°

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Railway hospital

Rawalpindi, Punjab Province, 40100, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 24298492 BACKGROUND

• 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.

  PMID: 26957772 BACKGROUND

• 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.

  PMID: 26644676 BACKGROUND

• 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.

  PMID: 24259822 BACKGROUND

• 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.

  PMID: 30881101 BACKGROUND

Study Officials

• Huma Riaz, PHD*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Both experimental and control groups will be treated simultaneously with different modes of endurance training

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 21, 2019
• Study Start: May 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 31, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)