Clinical trial NCT04173143: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Keywords: endurance training,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both experimental and control groups will be treated simultaneously with different modes of endurance training
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Numeric pain rating scale (NPRS)
timeFrame: Baseline
measure: Numeric pain rating scale (NPRS)
timeFrame: Post 4 week
measure: Numeric pain rating scale (NPRS)
timeFrame: Post 6 week
measure: CROM-Flexion
timeFrame: Baseline
measure: CROM-Flexion
timeFrame: Post 4 week
measure: CROM-Flexion
timeFrame: Post 6th Week
measure: CROM-Extention
timeFrame: Baseline
measure: CROM-Extention
timeFrame: Post 4th Week
measure: CROM-Extention
timeFrame: Post 6th Week
measure: Deep neck Flexor endurance
timeFrame: Baseline
measure: Deep neck Flexor endurance
timeFrame: Post 4th Week
measure: Deep neck Flexor endurance
timeFrame: Post 6th Week
measure: Craniocervical flexion test (Clinical test of endurance for experimental group)
timeFrame: Baseline
measure: Craniocervical flexion test (Clinical test of endurance for experimental group)
timeFrame: Post 4th week
measure: Craniocervical flexion test (Clinical test of endurance for experimental group)
timeFrame: Post 6th week
Secondary outcomes:
measure: Cranio-vertebral angle
timeFrame: Baseline
measure: Cranio-vertebral angle
timeFrame: Post 4th week
measure: Cranio-vertebral angle
timeFrame: Post 6th week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Huma Riaz, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.