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

NCT05352464 | Completed DMC

• 1 other identifier: REC -01052 Sana Sabir
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

cervical traction; Range of motion; pain; EMG biofeedback; disability

Outcome Measures

Primary Outcomes (4)

• 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.

  for six weeks

• 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.

  for six weeks

• 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.

  for six weeks

• 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.

  for six weeks

Study Arms (2)

cervical traction with EMG biofeedback

EXPERIMENTAL

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

Other: cervical traction with EMG biofeedback

cervical traction and conventional physical therapy

ACTIVE COMPARATOR

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.

Other: cervical traction and conventional physical therapy

Interventions

cervical traction with EMG biofeedback OTHER

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

cervical traction with EMG biofeedback

cervical traction and conventional physical therapy OTHER

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

cervical traction and conventional physical therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Khalid, MSOMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 28, 2022
• Study Start: April 1, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 19, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)