Cervical RadiculopathyNCT05887427
Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
A study testing Neural Mobilisation and Conservative physiotherapy in people with Cervical Radiculopathy, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Neural Mobilisation and Conservative physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2022to 6 Jan 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants meeting the following criteria were included in the study: age between 18 and 65 years, referred to physiotherapy with a diagnosis of cervical disc herniation, self-reported neck pain with a visual analog scale (VAS) score of more than 5, presence of pain radiating from the neck to the arm, and at least 3 of the following tests were positive: Spurling's Test, Upper Extremity Tension Test-1, Distraction Test, and ipsilateral cervical rotation less than 60 degrees. These tests were assessed by a trained examiner according to standardized procedures
Who cannot join
- Exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy.
Read the detailed description
This study was designed as a randomized controlled experimental study and was conducted in the Physiotherapy and Rehabilitation Department of Istanbul Medicana International Hospital. Population: The study included patients diagnosed with cervical disc herniation who were referred to physiotherapy sessions by a physician Patients were assigned to the Control Group(CG) or Neural Mobilization Group(NMG) by simple randomization. The control group received conventional physiotherapy while the neural mobilization group received neural mobilization of the ulnar median and radial nerves. The pain of the patients was evaluated with Numeric Pain Rating Sacale (NPRS) and Neuropathic Pain Questionnaire (NPQ) at the beginning and end of the intervention, while hand grip strength and pinch grip strength were evaluated with digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) and digital pinchmeter (JAMAR Plus Pinch Gauge). Pre- and post-intervention data were statistically analyzed and compared.
- Conditions
- Cervical Radiculopathy
- Being tested
- Neural Mobilisation, Conservative physiotherapy
- Keywords
- NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural MobilisationOther
Transcutaneous Electrical Stimulation, hotpack, ultrasound and neural mobilization(radial,ulnar,median)
Conservative physiotherapyOther
Hotpack,Transcutaneous Electrical Stimulation ,Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Neural Mobilisation Group (NMG) | Experimental | The neural mobilisation group received one session of conservative physiotherapy and neural mobilization at the end of the session. The content of the conservative program was the same in both groups. Before the neural mobilization application, a nerve stretching test was performed to provide a specific stretching position for each nerve and the patient was asked if he/she had any complaints. After adjusting the intensity of the neural mobilization tension, all participants were asked if they felt numbness, tension or tingling sensation in the nerve. When the symptoms were at a level that did not bother the patient, the nerve was held in that position for 10 seconds and then the nerve was left in the relaxation position. Each neural mobilization was performed in 10 repetitions. Receives: Other: Neural Mobilisation |
| Control Group (CG) | Active comparator | Control group patients received one session of conservative physiotherapy program. The conservative program consisted of 20 minutes of heat application to the cervical region, 20 minutes of Transcutaneous Electrical Stimulation (TENS) application and 5 minutes of ultrasound application. Receives: Other: Conservative physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NPRS)
Pain in the neck region of the participants was evaluated using NPRS before and after the intervention. On this scale, patients were asked to mark the pain they felt on a 10 cm scale. Accordingly, the participants marked the range of values "0" was no pain, and "10" was the most severe.
Measured: 2 Month
Neuropathic Pain Questionnaire (NPQ)
Before and after the intervention, the characteristics and severity of the patients' pain were evaluated with the Neuropathic Pain Questionnaire. This scale was used for initial screening of patients with pain. It has the ability to provide a quantitative measurement for the symptoms that are important in the diagnosis and evaluation of neuropathic pain. In the questionnaire consisting of 12 questions, 10 questions were asked about the nature of pain and the other two questions about changes in sensitivity.
Measured: 2 Month
Secondary outcomes (2)
Hand Grip Strength
A digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) , was used to measure hand grip strength.. The test was performed in an upright sitting position, 3 measurements were performed with one-minute intervals between each measurement and the averages were recorded. For painless grip strength, patients were asked to squeeze the dynamometer until they felt discomfort before and after treatment.The shoulder was in adduction and neutral position, elbow in 90° flexion, forearm in neutral position and wrist in 0 -30° extension and 0-15° ulnar deviation position while the patients were sitting in a chair with their arms supported.Both hands were measured separately.
Measured: 2 Month
Pinch Grip Strength
Pinch grip (two-point grip) strength was evaluated with a pinch meter (JAMAR Plus Pinch Gauge). The application was performed comparatively in both extremities; patients were sitting in a chair with support, shoulder in adduction and neutral position, elbow in 90˚ flexion, forearm in neutral position, wrist in 0-30˚ extension and 0-15˚ ulnar deviation position.Measurements were taken before and after the intervention. Three measurements were made with one minute intervals between each measurement and the averages were recorded.
Measured: 2 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start10 Nov 2022
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
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
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Büşra Sökmen Yıldırım, Uskudar University
- Investigators
- BERNA KARAMANCIOĞLU, Study director, berna.karamancioğlu@uskudar.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887427
- Sponsor's protocol ID
- Üsküdar Üniversitesi
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 2 Jun 2023
- 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 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Neural Mobilization in Cervical Radiculopathy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05887427
- Acronym / sponsor ID
- Üsküdar Üniversitesi
- Conditions
- Cervical Radiculopathy
- Keywords
- NEURAL MOBİLİSATİON,CERVİCAL RADİCULOPATHY,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 2 Jun 2023 (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.
The aim of this study was to investigate the immediate effect of neural mobilization techniques, one of the manual therapy methods that can be used in the treatment of cervical radiculopathy.
Detailed description
This study was designed as a randomized controlled experimental study and was conducted in the Physiotherapy and Rehabilitation Department of Istanbul Medicana International Hospital. Population: The study included patients diagnosed with cervical disc herniation who were referred to physiotherapy sessions by a physician Patients were assigned to the Control Group(CG) or Neural Mobilization Group(NMG) by simple randomization. The control group received conventional physiotherapy while the neural mobilization group received neural mobilization of the ulnar median and radial nerves. The pain of the patients was evaluated with Numeric Pain Rating Sacale (NPRS) and Neuropathic Pain Questionnaire (NPQ) at the beginning and end of the intervention, while hand grip strength and pinch grip strength were evaluated with digital hand dynamometer (JAMAR Plus Digital Hand Dynamometer) and digital pinchmeter (JAMAR Plus Pinch Gauge). Pre- and post-intervention data were statistically analyzed and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural Mobilisation Group (NMG) | Experimental | Other: Neural MobilisationThe neural mobilisation group received one session of conservative physiotherapy and neural mobilization at the end of the session. The content of the conservative program was the same in both groups. Before the neural mobilization application, a nerve stretching test was performed to provide a specific stretching position for each nerve and the patient was asked if he/she had any complaints. After adjusting the intensity of the neural mobilization tension, all participants were asked if they felt numbness, tension or tingling sensation in the nerve. When the symptoms were at a level that did not bother the patient, the nerve was held in that position for 10 seconds and then the nerve was left in the relaxation position. Each neural mobilization was performed in 10 repetitions. |
| Control Group (CG) | Active comparator | Other: Conservative physiotherapyControl group patients received one session of conservative physiotherapy program. The conservative program consisted of 20 minutes of heat application to the cervical region, 20 minutes of Transcutaneous Electrical Stimulation (TENS) application and 5 minutes of ultrasound application. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants meeting the following criteria were included in the study: age between 18 and 65 years, referred to physiotherapy with a diagnosis of cervical disc herniation, self-reported neck pain with a visual analog scale (VAS) score of more than 5, presence of pain radiating from the neck to the arm, and at least 3 of the following tests were positive: Spurling's Test, Upper Extremity Tension Test-1, Distraction Test, and ipsilateral cervical rotation less than 60 degrees. These tests were assessed by a trained examiner according to standardized procedures
Key exclusion criteria (1 listed)
- Exclusion criteria were surgical intervention in the head and neck region, history of fracture in the head and neck region, known chronic disease, infection and structural disorders in the bone and soft tissue in the cervical spine, malignancy and severe osteoporosis.
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 |
|---|---|---|
| Neural MobilisationTranscutaneous Electrical Stimulation, hotpack, ultrasound and neural mobilization(radial,ulnar,median) | Other | Neural Mobilisation Group (NMG) |
| Conservative physiotherapyHotpack,Transcutaneous Electrical Stimulation ,Ultrasound | Other | Control Group (CG) |
Primary outcome
Numerical Pain Rating Scale (NPRS)
Time frame: 2 Month
Pain in the neck region of the participants was evaluated using NPRS before and after the intervention. On this scale, patients were asked to mark the pain they felt on a 10 cm scale. Accordingly, the participants marked the range of values "0" was no pain, and "10" was the most severe.
Neuropathic Pain Questionnaire (NPQ)
Time frame: 2 Month
Before and after the intervention, the characteristics and severity of the patients' pain were evaluated with the Neuropathic Pain Questionnaire. This scale was used for initial screening of patients with pain. It has the ability to provide a quantitative measurement for the symptoms that are important in the diagnosis and evaluation of neuropathic pain. In the questionnaire consisting of 12 questions, 10 questions were asked about the nature of pain and the other two questions about changes in sensitivity.
2 secondary outcomes
Hand Grip Strength
Time frame: 2 Month
Pinch Grip Strength
Time frame: 2 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- 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. This study is not recruiting at the moment.
BERNA KARAMANCIOĞLU study director
berna.karamancioğlu@uskudar.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural Mobilisation and Conservative physiotherapy in people with Cervical Radiculopathy, run by Uskudar University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 2 Jun 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Pain Rating Scale (NPRS) (time frame: 2 Month). The study lists 2 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 2 Jun 2023.