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

NCT ID: NCT05352464

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-19

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

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cervical traction with EMG biofeedback

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

Group Type: EXPERIMENTAL

cervical traction with EMG biofeedback

Intervention Type: 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 and conventional physical therapy

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.

Group Type: ACTIVE_COMPARATOR

cervical traction and conventional physical therapy

Intervention Type: 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

Interventions

cervical traction with EMG biofeedback

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

cervical traction and conventional physical therapy

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

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Khalid, MSOMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC -01052 Sana Sabir

Identifier Type: -

Identifier Source: org_study_id