Cervical RadiculopathyNCT06932510
EFFECTS OF INFLATTABLE CERVICAL TRACTION COLLAR AS COMPARED TO MANUAL TRACION IN THE MANAGEMENT OF CERVICAL RADICULOPATHY
A study testing Manual Traction and Cervical Traction Collar in people with Cervical Radiculopathy, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 44 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Manual Traction and Cervical Traction Collar
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Apr 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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. -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Foundation University College of Physical Therapy, Foundation University Islamabad.
Islamabad, 64000
About this study
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.
Read the detailed description
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 on
- Pain
- Functional Disability
- Range of motion Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method.
- Conditions
- Cervical Radiculopathy
- Being tested
- Manual Traction, Cervical Traction Collar
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TractionProcedure or surgery
Manual cervical traction will be administered by a trained physical therapist.
Cervical Traction CollarDevice
Cervical traction will be administered via Cervical Traction Collar.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cervical Traction Collar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Osama, Foundation University Islamabad
- Investigators
- Mehwish Iqbal, DPT, Principal investigator, Foundation University IslamabadMuhammad Osama, PhD, Study director, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932510
- Sponsor's protocol ID
- FUI/CTR/2025/5
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF INFLATTABLE CERVICAL TRACTION COLLAR AS COMPARED TO MANUAL TRACION IN THE MANAGEMENT OF CERVICAL RADICULOPATHY
- ClinicalTrials.gov ID
- NCT06932510
- Acronym / sponsor ID
- FUI/CTR/2025/5
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 17 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 on
- Pain
- Functional Disability
- Range of motion Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Traction | Active comparator | Procedure: Manual Traction"Manual Traction Group" will be given Manual Traction with facet joint and Upper Extremity Neural Mobilization with Hot Pack and electrotherapy for 20 minutes. |
| Cervical Traction Collar | Experimental | Device: Cervical Traction Collar"Cervical Traction Collar" will be given Manual Traction with facet joint and Upper Extremity Neural Mobilization with Hot Pack and electrotherapy for 20 minutes. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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. -
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual TractionManual cervical traction will be administered by a trained physical therapist. | Procedure or surgery | Manual Traction |
| Cervical Traction CollarCervical traction will be administered via Cervical Traction Collar. | Device | Cervical Traction Collar |
Primary outcome
Neck Pain
Time frame: 2 weeks
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.
Neck Disability Index
Time frame: 2 weeks
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.
Cervical Range of Motion
Time frame: 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mehwish Iqbal, DPT principal investigator
Foundation University Islamabad
Muhammad Osama, PhD study director
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Traction and Cervical Traction Collar in people with Cervical Radiculopathy, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck Pain (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.