NCT06932510

Brief Summary

This study is a randomized control trial and the purpose of this study is to determine the effects of inflatable cervical traction collar as compared to manual traction in the management of cervical radiculopathy.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

April 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 10, 2025

Last Update Submit

April 10, 2025

Conditions

Cervical Radiculopathy

Outcome Measures

Primary Outcomes (3)

  • Neck Pain

    Neck pain will be measured using Visual Analogue Scale, which has scoring from 0 to 100 mm, and a higher score represents greater pain and a lower score represents less pain.

    2 weeks

  • Neck Disability Index

    It consists of 10 items, each scored on a scale of 0-5, with 0 indicating no pain or limitations and 5 indicating the worst imaginable pain or limitation. The total score ranges from 0-50, with higher score indicating greater disability. The score can also be expressed in terms of percentage.

    2 weeks

  • Cervical Range of Motion

    Cervical range of motion will be measured using a Goniometer. A higher score represents greater range of motion, and lower score represents decreased or lesser range of morion of cervical spine.

    2 weeks

Study Arms (2)

Manual Traction

ACTIVE COMPARATOR

"Manual Traction Group" will be given Manual Traction with facet joint and Upper Extremity Neural Mobilization with Hot Pack and electrotherapy for 20 minutes.

Procedure: Manual Traction

Cervical Traction Collar

EXPERIMENTAL

"Cervical Traction Collar" will be given Manual Traction with facet joint and Upper Extremity Neural Mobilization with Hot Pack and electrotherapy for 20 minutes.

Device: Cervical Traction Collar

Interventions

Manual TractionPROCEDURE

Manual cervical traction will be administered by a trained physical therapist.

Manual Traction
Cervical Traction CollarDEVICE

Cervical traction will be administered via Cervical Traction Collar.

Cervical Traction Collar

Eligibility Criteria

Age19 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 19-44 years Neck pain \>4 and \<8 on NPRS NDI scoring \<24(moderate disability) Positive Spurling test Positive Distraction Test Active and passive ROM limited/painful towards the side of pain Radiating Symptoms Numbness/paresthesia radiating to upper limb Both genders Positive - Upper Limb Neural Tension Tests (ULNTT) will be included. -

You may not qualify if:

  • Patients having Bilateral radiating sign and symptoms Cervical myelopathy Cervical syringomyelia Rheumatoid arthritis Thoracic outlet syndrome Brachial plexopathy Cervical Rib Vertebrobasilar insufficiency Recent history of fracture, surgery, trauma or whiplash Positive alar ligament stress test Positive sharp purser stress test Cervical instability Cancer, tumor or sudden weight loss.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy, Foundation University Islamabad.

Islamabad, 64000, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Mehwish Iqbal, DPT

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

  • Muhammad Osama, PhD

    Foundation University Islamabad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and outcome assessor are blind to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2025

First Posted

April 17, 2025

Study Start

April 25, 2025

Primary Completion

October 1, 2025

Study Completion

October 15, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)