Cervical RadiculopathyNCT06276699
Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy
A study testing 1.Isometric exercise 2.combined conservative treatment in people with Cervical Radiculopathy, run by University of Peradeniya.
Trial summary
This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- 1.Isometric exercise 2.combined conservative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 35-60 years
- Neck pain > 3 months
- Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side < 60
Who cannot join
- Presence of any signs or symptoms of medical red flags
- Less than 3(positive) items for the CPR
- Bilateral arm radiating pain
- Osteoporosis
- Tumor
- Whiplash injury
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- Pregnancy woman
- Rheumatoid arthritis
- Post-surgery to cervical/thoracic spine
About this study
Official title: Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy - A Randomized Controlled Trial
This intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.
- Conditions
- Cervical Radiculopathy
- Being tested
- 1.Isometric exercise 2.combined conservative treatment
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.Isometric exercise 2.combined conservative treatmentProcedure or surgery
Also called Conservative management (Cervical traction, Neural mobilization)
Exercise programs will be taught to patients with details by an experienced physiotherapist at the beginning of the study. Cervical Traction Patient will sit upright posture on a chair. Mechanical traction will be applied. It includes placement of a halo device around the neck, then the harness will be attached to the machine that applies traction force through-out the treatment, the device is controlled by the control panel. Intermittent mechanical traction will be applied for 10 minutes in which pull for 10 seconds and 5 seconds rest will be applied. Neural mobilization will be carried out using Butler's approach. The subject will be positioned in supine, and the median nerve will be mobilized using a slider.
| Study group | Role | What they receive |
|---|---|---|
| 1.Isometric exercise | Placebo comparator | Not described Receives: Procedure: 1.Isometric exercise 2.combined conservative treatment |
| 2. Combined conservative treatment | Experimental | Not described Receives: Procedure: 1.Isometric exercise 2.combined conservative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline.
Visual analog scale (VAS) is a measurement tool used in order to measure the pain Zero indicates no pain and 10 indicates maximum pain that patient feels
Measured: 2 times a week for 6 weeks
Secondary outcomes (2)
Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline.
Measured by using a goniometer
Measured: 2 times a week for 6 weeks
Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline
Neck disability index (NDI) will be used to measure the patient's level of disability
Measured: 2 times a week for 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Peradeniya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, T.Neeraja, University of Peradeniya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276699
- Sponsor's protocol ID
- FAHS
- Status last verified
- Apr 2024
- First submitted
- 2 Feb 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combination of Conservative Treatments Compared to Isometric Exercise on Clinical Outcomes in Patients With Cervical Radiculopathy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06276699
- Acronym / sponsor ID
- FAHS
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of PeradeniyaUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Feb 2024 (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 intervention study is to evaluate the efficacy of a combination of conservative treatments compared to isometric exercise on clinical outcomes in patients with cervical radiculopathy. It is a randomized, parallel, 2-arm superiority trial study. The study will be conducted at the District General Hospital in Trincomalee, where patients with cervical radiculopathy seek medical care. Patients who refer to the Department of Physical Medicine (DPM) from the Out Patients Department (OPD), orthopedic clinic and surgical clinic with a diagnosis of cervical radiculopathy or neck and arm pain (symptoms extending distal to the shoulder) will be eligible for recruitment. The study details will be explained to the subjects in the language that they best understand. Written informed consent will be obtained from the individuals who express their willingness to participate in the study, and they will sign the informed consent document accordingly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Isometric exercise | Placebo comparator | Procedure: 1.Isometric exercise 2.combined conservative treatment |
| 2. Combined conservative treatment | Experimental | Procedure: 1.Isometric exercise 2.combined conservative treatment |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 35-60 years
- Neck pain > 3 months
- Clinical Prediction Rules - Positive Spurling's test (+) Distraction test (+) Upper limb tension test A (+) Cervical rotation on affected side < 60
Key exclusion criteria (9 listed)
- Presence of any signs or symptoms of medical red flags
- Less than 3(positive) items for the CPR
- Bilateral arm radiating pain
- Osteoporosis
- Tumor
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 |
|---|---|---|
| 1.Isometric exercise 2.combined conservative treatmentAlso: Conservative management (Cervical traction, Neural mobilization)Exercise programs will be taught to patients with details by an experienced physiotherapist at the beginning of the study. Cervical Traction Patient will sit upright posture on a chair. Mechanical traction will be applied. It includes placement of a halo device around the neck, then the harness will be attached to the machine that applies traction force through-out the treatment, the device is controlled by the control panel. Intermittent mechanical traction will be applied for 10 minutes in which pull for 10 seconds and 5 seconds rest will be applied. Neural mobilization will be carried out using Butler's approach. The subject will be positioned in supine, and the median nerve will be mobilized using a slider. | Procedure or surgery | 1.Isometric exercise, 2. Combined conservative treatment |
Primary outcome
Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline.
Time frame: 2 times a week for 6 weeks
Visual analog scale (VAS) is a measurement tool used in order to measure the pain Zero indicates no pain and 10 indicates maximum pain that patient feels
2 secondary outcomes
Difference in cervical ROM measured by Goniometry between combination of treatments and isometric exercises at 6-weeks post-baseline.
Time frame: 2 times a week for 6 weeks
Difference in functional disability measured by Neck Disability Index between combination of treatments and isometric exercises at 6-weeks post-baseline
Time frame: 2 times a week for 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 1.Isometric exercise 2.combined conservative treatment in people with Cervical Radiculopathy, run by University of Peradeniya.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Difference in pain intensity measured by Visual Analogue Scale (VAS) between combination of treatments and isometric exercises at 6-weeks post-baseline. (time frame: 2 times a week for 6 weeks). 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 16 Apr 2024.