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

NCT ID: NCT04173143

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Mechanical Neck Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Both experimental and control groups will be treated simultaneously with different modes of endurance training
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Craniocervical flexion training with pressure biofeedback

Intervention Type 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 2

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

Group Type ACTIVE_COMPARATOR

Craniocervical flexion training without pressure biofeedback

Intervention Type 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

Interventions

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Craniocervical flexion training with pressure biofeedback

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 DEVICE

Craniocervical flexion training without pressure biofeedback

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huma Riaz, PHD*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Railway hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 24298492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26957772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26644676 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24259822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30881101 (View on PubMed)

Other Identifiers

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RiphahIU Rabia Ashfaq

Identifier Type: -

Identifier Source: org_study_id

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