NCT05332418

Brief Summary

PURPOSE: to investigate effect of electromagnetic field therapy on neck pain and proprioception in cervical radiculopathy patients BACKGROUND: Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

April 11, 2022

Last Update Submit

May 27, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Visual analogue scale for pain (VAS-P)

    is a method for measuring the intensity of pain on a horizontal straight line of fixed length (10 cm), as the left end of the line showed the greatest pain score \& the right end showed the least pain scores, then the patient was asked to put a mark, on the line according to his/her pain sensation, with a higher score representing the higher level of pain

    4 weeks

  • cervical proprioception using cervical joint position error test (JPET)

    * The subject will be instructed to perform an active head rotation to one side, after which returns back to the neutral or starting head position. * The test will be performed in a 3 trials in each direction: right, left rotations , extension and flexion.

    4 weeks

  • Neck disability index

    includes 10 items as follows: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation, with a score (0:5) for every point. The maximum score is 50, with the interpretation scoring (no disability = 0: 4, mild disability 5:14, moderate disability 15:24, severe disability 25: 34 and complete disability above 34

    4 weeks

  • Cervical range of motion (CROM) goniometer device

    The CROM is an inclinometers system with a gravitational reference that is suitable for evaluating the active cervical spine movements in different direction

    4 weeks

Study Arms (2)

study group

EXPERIMENTAL

the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks

Other: selected exercise programDevice: Electromagenetic Field therapy

control group

EXPERIMENTAL

the control group which received the selected exercise program

Other: selected exercise program

Interventions

therapeutic ultrasound, Static neck exercise, Educational postural correction, and Home neck exercise program for patient

control groupstudy group

Magnetotherapy application the device will be adjusted around the neck and shoulder area at low frequency (50 Hz), with intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60) , and the application time (10 minutes)

study group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranging from 30:45
  • Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
  • With mild to moderate cervical disability according to neck disability index
  • Body mass index (18.5 to 29.9) Kg/m2.

You may not qualify if:

  • Cervical myelopathy.
  • Patients with previous cervical surgery.
  • Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
  • Any other musculoskeletal disorders of the spine or upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lama Saad El-Din Mahmoud

Al Jīzah, Select State, 0020, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 18, 2022

Study Start

January 15, 2022

Primary Completion

April 30, 2022

Study Completion

June 30, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Locations