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临床试验/NCT04173143
NCT04173143已完成不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Craniocervical flexion test (Clinical test of endurance for experimental group)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• 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
  • •Patients with Forward neck posture and a Craniovertebral angle less than 48°

排除标准

  • •• 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.

研究组 & 干预措施

Group 1

Experimental

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

干预措施: Craniocervical flexion training with pressure biofeedback (Device)

Group 2

Active Comparator

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

干预措施: Craniocervical flexion training without pressure biofeedback (Other)

结局指标

主要结局

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

时间窗: 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.

CROM-Flexion

时间窗: 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.

CROM-Extention

时间窗: 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.

Deep neck Flexor endurance

时间窗: Post 6th Week

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

Numeric pain rating scale (NPRS)

时间窗: 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.

Numeric pain rating scale (NPRS)

时间窗: 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.

Numeric pain rating scale (NPRS)

时间窗: 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.

CROM-Flexion

时间窗: 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.

CROM-Flexion

时间窗: 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.

CROM-Extention

时间窗: 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.

CROM-Extention

时间窗: 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.

Deep neck Flexor endurance

时间窗: Baseline

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

Deep neck Flexor endurance

时间窗: Post 4th Week

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

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • Cranio-vertebral angle(Post 6th week)
  • Cranio-vertebral angle(Baseline)
  • Cranio-vertebral angle(Post 4th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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