NCT06695312

Brief Summary

To investigate the Effect of High Tone Power Therapy on Neck Pain and Proprioception in Cervical Radiculopathy Patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

November 16, 2024

Last Update Submit

November 24, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • cervical joint position error test

    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

    four 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

    four weeks

  • CROM

    Cervical range of motion measured using CROM in different directions

    four weeks

Secondary Outcomes (1)

  • Visual analogue scale for pain (VAS-P)

    four weeks

Study Arms (2)

study group

OTHER

the study group received the selected exercise program in addition to High Tone Power Therapy

Other: selected exercise programDevice: High Tone Power Therapy

control group

OTHER

therapeutic ultrasound, Static neck exercise,

Other: selected exercise program

Interventions

therapeutic ultrasound, Static neck exercise

control groupstudy group

High Tone Power Therapy delivered in cervical region 3 times per week for four weeks

study group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Their ages range from 35 to 50 years.
  • Both sex
  • With mild to moderate cervical disability according to the neck disability index
  • Unilateral cervical radiculopathy for more than 6 months.
  • Cervical radiculopathy due to disc prolapse (C5-C6) (C6-C7) mild to moderate or disc prolapse according to magnetic resonance image (MRI).
  • Normal body mass index (18.5 - 24.99Kg/m2).

You may not qualify if:

  • Any other musculoskeletal disorders of the spine or upper extremity
  • Patients with any other Neurological deficits, psychiatric disease Cervical myelopathy, Cognitive problems, vertebral fractures and previous history of spine or cervical surgery.
  • Neck pain with vertigo or with bilateral upper limbs referred pain.
  • Clinical instability, recent trauma and vertebrobasilar insufficiency.
  • Structural abnormalities of the spine, osteoporosis, and spasmodic torticollis.
  • Inflammatory or other specific disorders of spina such as ankylosing spondylitis and rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 university

Giza, Giza Governorate, 0020, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Lama Saad El-Din ED Mahmoud

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

Study Record Dates

First Submitted

November 16, 2024

First Posted

November 19, 2024

Study Start

September 15, 2024

Primary Completion

November 30, 2024

Study Completion

December 15, 2024

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations