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Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
cervical traction with EMG biofeedback
cervical traction and conventional physical therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring cervical traction, Range of motion, pain, EMG biofeedback, disability

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptoms duration was more than one month up to six months.
  • Radiculopathy due to muscle spasm.
  • Radiculopathy due to postero-lateral disc herniation.
  • Pain radiating with numbness and tingling sensations to both arms, forearms and hands.

Exclusion Criteria:

  • Patients diagnosed with thoracic outlet syndrome, diabetes mellitus, and/or carpel tunnel syndrome.
  • Patients had severe sensory and/or motor manifestations.
  • Patients had manifestations of central cervical disc herniation.
  • Congenital conditions of the cervical spine.
  • Patients with contraindications to mobilization techniques and those with dizziness due to vertebrobasilar insufficiency or vestibular dysfunctions.
  • Cervical Fractures.

Sites / Locations

  • Fauji Foundation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cervical traction with EMG biofeedback

cervical traction and conventional physical therapy

Arm Description

Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device

Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position.

Outcomes

Primary Outcome Measures

Visual Analogue Scale (VAS):
It is a subjective tool used to measure intensity of pain. It starts from 0 meaning "No pain" to 10 meaning "Worst pain". The reliability and validity of VAS measured by ICC is 0.97 and 0.941 respectively.Assesment to be done on baseline,2nd week,4th week and 6th week.
Neck Disability Index (NDI)
It is also a subjective tool used to evaluate neck disability. It ranks from 0 meaning "No pain" to 5 meaning "Worst imaginable pain". The reliability and validity if NDI measured by Cronbach's alpha is 0.89 and 0.60-0.70 respectively. Assessment to be done at baseline,2nd week,4th week and 6th week.
EMG biofeedback
It is an electric device use to generate electrical feedback signals from activation of muscles. The reliability and validity of EMG biofeedback is 0.815-0.979 (19) and 0.781-0.907 respectively.Assesment to be done at baseline,2nd week,4th week and 6th week.
Inclinometer.
Inclinometers have dials or digital readouts that display the angle at which the inclinometer is situated relative to the line of gravity. Inclinometer measurements of cervical flexion, extension, lateral flexion, and rotation were found to be reliable for all three methods with ICCs ranging from 0.89 to 0.94.Assesment to be done at baseline,2nd week,4th week and 6th week.

Secondary Outcome Measures

Full Information

First Posted
April 25, 2022
Last Updated
September 5, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05352464
Brief Title
Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy
Official Title
Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides.
Detailed Description
Cervical radiculopathy is a neurological condition which is caused by underlying musculoskeletal disorders including herniated disc and degenerative changes in cervical spine that results in narrowing or stenosis of intervertebral foramen. This narrowing leads to compression of nerve root at the respective foramen. The compressed nerve root produces symptoms like numbness, tingling, pain and motor weakness in neck and upper extremity. These symptoms appear at the dermatome and myotome distribution of the affected nerve root. Mostly the cervical radiculopathy is present unilaterally but in severe cases it can appear bilaterally where bony spurs are found at various levels and nerve root in under compression on both sides. The annual incidence rate of cervical radiculopathy is reported to be 107.3 per 100,000 of men and 63.5 per 100,000 of women. So accordingly, the condition is more common in males than females. Although no definitive treatment plan for cervical radiculopathy has been developed, there is a general consensus in the literature that using manual therapy techniques in conjunction with therapeutic exercise is effective in terms of increasing function and active range of motion (AROM). The focus will most likely be on reducing pain and disability. Recent researches have shown that exercise therapy has the highest beneficial outcomes. Treatment options for rehabilitation plan includes: Education and advice, Manual Therapy - PAIVMs (Passive Accessory Intervertebral Movements) / PPIVMs (Passive Physiological Intervertebral Movements) / NAGs (Natural Apophyseal Glides) / SNAGs (Sustained Natural Apophyseal Glides),Exercise Therapy - AROM, stretching and strengthening and Postural re-education Cervical traction and electromyography (EMG) biofeedback have been administered by many physiotherapists and positive outcomes are revealed. Traction not only relives nerve root compression but also helps in managing acute pain instantly whereas EMG biofeedback is used to generate an electrical feedback signal in response to muscle activation and helps patients to learn a more effective way of using their weak muscles

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
cervical traction, Range of motion, pain, EMG biofeedback, disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical traction with EMG biofeedback
Arm Type
Experimental
Arm Description
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device
Arm Title
cervical traction and conventional physical therapy
Arm Type
Active Comparator
Arm Description
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position.
Intervention Type
Other
Intervention Name(s)
cervical traction with EMG biofeedback
Intervention Description
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position. Ask the patient to assume sitting position on a comfortable chair. Place surface electrodes of EMG biofeedback at the level of C5-6 Para spinal muscles to pick up the activity of the muscles and convert it to vis-ual and auditory impulses produced from the device. Tell the patient to try to relax the tension of the neck muscles as much as he can by lowering the visual and auditory impulses from the device
Intervention Type
Other
Intervention Name(s)
cervical traction and conventional physical therapy
Intervention Description
Continuous traction for 15-20 minutes in sitting position on average at an angle of 15-25 degrees of cervical flexion or in the most pain-free position
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS):
Description
It is a subjective tool used to measure intensity of pain. It starts from 0 meaning "No pain" to 10 meaning "Worst pain". The reliability and validity of VAS measured by ICC is 0.97 and 0.941 respectively.Assesment to be done on baseline,2nd week,4th week and 6th week.
Time Frame
for six weeks
Title
Neck Disability Index (NDI)
Description
It is also a subjective tool used to evaluate neck disability. It ranks from 0 meaning "No pain" to 5 meaning "Worst imaginable pain". The reliability and validity if NDI measured by Cronbach's alpha is 0.89 and 0.60-0.70 respectively. Assessment to be done at baseline,2nd week,4th week and 6th week.
Time Frame
for six weeks
Title
EMG biofeedback
Description
It is an electric device use to generate electrical feedback signals from activation of muscles. The reliability and validity of EMG biofeedback is 0.815-0.979 (19) and 0.781-0.907 respectively.Assesment to be done at baseline,2nd week,4th week and 6th week.
Time Frame
for six weeks
Title
Inclinometer.
Description
Inclinometers have dials or digital readouts that display the angle at which the inclinometer is situated relative to the line of gravity. Inclinometer measurements of cervical flexion, extension, lateral flexion, and rotation were found to be reliable for all three methods with ICCs ranging from 0.89 to 0.94.Assesment to be done at baseline,2nd week,4th week and 6th week.
Time Frame
for six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptoms duration was more than one month up to six months. Radiculopathy due to muscle spasm. Radiculopathy due to postero-lateral disc herniation. Pain radiating with numbness and tingling sensations to both arms, forearms and hands. Exclusion Criteria: Patients diagnosed with thoracic outlet syndrome, diabetes mellitus, and/or carpel tunnel syndrome. Patients had severe sensory and/or motor manifestations. Patients had manifestations of central cervical disc herniation. Congenital conditions of the cervical spine. Patients with contraindications to mobilization techniques and those with dizziness due to vertebrobasilar insufficiency or vestibular dysfunctions. Cervical Fractures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Khalid, MSOMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Cervical Traction With and Without EMG Biofeedback in Patients With Cervical Radiculopathy

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