Cervico BrachialgiaNM-CBNNCT06913062
Neural Mobilization in Cervico-Brachial Neuralgia
A study testing conventional rehabilitation and neural mobilisation in people with Cervico Brachialgia, run by Hopital Charles Nicolle at 1 site in Tunisia.
Trial summary
This study aimed to compare the effectiveness of neural mobilization (NM) combined with conventional rehabilitation versus conventional rehabilitation alone in patients with chronic common cervico-brachial neuralgia (CBN), focusing on pain, cervical range of motion (ROM), functional disability, and psychological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervico Brachialgia
- What is being tested?
- conventional rehabilitation and neural mobilisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2024to 30 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- with chronic common CBN
Who cannot join
- secondary CBN
- prior cervical surgery
- cervical trauma
- recent central or peripheral neurological conditions
- unstable cauda equina lesions,
- untreated tumors or infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Neural Mobilization With Conventional Rehabilitation: A New Approach to Cervico-Brachial Neuralgia Management
This study aimed to compare the effectiveness of neural mobilization (NM) combined with conventional rehabilitation versus conventional rehabilitation alone in patients with chronic common cervico-brachial neuralgia (CBN), focusing on pain, cervical range of motion (ROM), functional disability, and psychological state.
A randomized controlled trial was conducted including patients with chronic CBN. They were randomized into two groups: control group received standard rehabilitation, while NM Group received the same treatment with additional NM techniques. Evaluations were conducted pre- and post-treatment, assessing pain, cervical ROM, functional disability and psychological state via the Beck Depression Inventory.
- Conditions
- Cervico Brachialgia
- Being tested
- conventional rehabilitation, neural mobilisation
- Keywords
- cervico-brachial neuralgia, neural mobilization, pain, function
- Medical subject headings
- Brachial Plexus Neuritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional rehabilitationProcedure or surgery
For control group, the conventional rehabilitation protocol aimed to alleviate muscular and neuropathic pain in the short term, improve cervical mobility, reduce muscle tension, and increase muscle strength in the medium term, and promote a healthy lifestyle along with socio-professional reintegration in the long term. The principles included educating patients about their condition, respecting pain thresholds, and considering fatigue levels. Each patient received treatment for two months, with three sessions per week, each lasting about one hour. The protocol consisted of three phases: the first week focused on relaxation through massage and low-frequency electrotherapy; the second week introduced passive joint mobilizations; and from the third week, muscle stretching and strengthening exercises were incorporated. Additionally, functional exercises targeting daily activities and body awareness techniques are included to maintain proper posture.
neural mobilisationProcedure or surgery
The protocol was structured around three main axes: treatment of interfaces (joint mobilizations and traction), direct treatment (using neurodynamic techniques), and indirect treatment (neural self-mobilization and lifestyle advice). The treatment included various stages for each ULNT technique. ULNT1 targeted the median nerve and involved shoulder abduction, elbow extension, and head inclination. ULNT2 focused on scapular depression and targeted cervical roots. ULNT3 emphasized radial nerve tension with internal rotation of the shoulder, while ULNT4 addressed ulnar nerve tension through elbow flexion and shoulder abduction. Each technique was executed with specific movements, maintained for 20 to 30 seconds, and repeated 15 times, followed by gentle scapular mobilizations until pain resolution.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | For control group, the conventional rehabilitation protocol aimed to alleviate muscular and neuropathic pain in the short term, improve cervical mobility, reduce muscle tension, and increase muscle strength in the medium term, and promote a healthy lifestyle along with socio-professional reintegration in the long term. The principles included educating patients about their condition, respecting pain thresholds, and considering fatigue levels. Each patient received treatment for two months, with three sessions per week, each lasting about one hour. The protocol consisted of three phases: the first week focused on relaxation through massage and low-frequency electrotherapy; the second week introduced passive joint mobilizations; and from the third week, muscle stretching and strengthening exercises were incorporated. Additionally, functional exercises targeting daily activities and body awareness techniques are included to maintain proper posture. Receives: Procedure: conventional rehabilitation |
| NM arm | Experimental | For NM group, long-term goals included improving neuromeningeal mobility and restoring function to neural structures. Each patient received the treatment for two months, with three sessions per week, each lasting about one hour. After addressing joint limitations and muscle tensions affecting radicular mobility, NM was introduced starting from the fourth week. The protocol was structured around three main axes: treatment of interfaces (joint mobilizations and traction), direct treatment (using neurodynamic techniques), and indirect treatment (neural self-mobilization and lifestyle advice). The treatment included various stages for each ULNT technique [9]. ULNT1 targeted the median nerve and involved shoulder abduction, elbow extension, and head inclination. ULNT2 focused on scapular depression and targeted cervical roots. ULNT3 emphasized radial nerve tension with internal rotation of the shoulder, while ULNT4 addressed ulnar nerve tension through elbow flexion and shoulder abduction Receives: Procedure: conventional rehabilitation; Procedure: neural mobilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Pain: was assessed using the Visual Analog Scale (VAS) which ranges from 0 (no pain) to 10 (maximal imaginable pain)
Measured: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
Secondary outcomes (3)
mobility
Joint mobility assessment: focused on both the qualitative and quantitative aspects of movement. Following active movement, the therapist conducts a passive evaluation to analyze the end-range of motion (ROM) and any associated pain
Measured: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
function
Functional assessment: was performed using the Copenhagen Neck Functional Disability Scale (CNFDS) in its Arabic version. It is a self-administered questionnaire that measures functional disability levels in patients suffering from cervical pain. The CNFDS consists of 15 questions addressing various aspects of daily life, including headache, sleep quality, concentration, and psychosocial factors such as social interaction and emotional relationships. Scores on the scale range from 0 (no disability) to 30 (maximum disability)
Measured: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
depression
Psychological evaluation: was conducted using the Beck Depression Inventory (BDI). The Arabic validated version of this inventory was used to gauge the psychological state of patients, providing a quantitative estimate of depressive symptoms. The BDI includes 21 items that describe specific behavioral manifestations of depression, rated on a scale from 0 to 3. The final score is interpreted in terms of depression severity: 0-9 indicates minor depression, 10-18 indicates mild depression, 19-29 indicates moderate depression, and 30-63 indicates severe depression
Measured: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start2 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervico BrachialgiaStudies 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Charles Nicolle
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Bouden, Hopital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913062
- Sponsor's protocol ID
- ECR-OMG-2024-302
- Other IDs
- ECR-OMG-2024-303
- Acronym
- NM-CBN
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 8 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 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Neural Mobilization With Conventional Rehabilitation: A New Approach to Cervico-Brachial Neuralgia Management
- ClinicalTrials.gov ID
- NCT06913062
- Acronym / sponsor ID
- NM-CBN / ECR-OMG-2024-302
- Conditions
- Cervico Brachialgia
- Keywords
- cervico-brachial neuralgia, neural mobilization, pain, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hopital Charles NicolleUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 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 aimed to compare the effectiveness of neural mobilization (NM) combined with conventional rehabilitation versus conventional rehabilitation alone in patients with chronic common cervico-brachial neuralgia (CBN), focusing on pain, cervical range of motion (ROM), functional disability, and psychological state.
A randomized controlled trial was conducted including patients with chronic CBN. They were randomized into two groups: control group received standard rehabilitation, while NM Group received the same treatment with additional NM techniques. Evaluations were conducted pre- and post-treatment, assessing pain, cervical ROM, functional disability and psychological state via the Beck Depression Inventory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Procedure: conventional rehabilitationFor control group, the conventional rehabilitation protocol aimed to alleviate muscular and neuropathic pain in the short term, improve cervical mobility, reduce muscle tension, and increase muscle strength in the medium term, and promote a healthy lifestyle along with socio-professional reintegration in the long term. The principles included educating patients about their condition, respecting pain thresholds, and considering fatigue levels. Each patient received treatment for two months, with three sessions per week, each lasting about one hour. The protocol consisted of three phases: the first week focused on relaxation through massage and low-frequency electrotherapy; the second week introduced passive joint mobilizations; and from the third week, muscle stretching and strengthening exercises were incorporated. Additionally, functional exercises targeting daily activities and body awareness techniques are included to maintain proper posture. |
| NM arm | Experimental | Procedure: conventional rehabilitation, Procedure: neural mobilisationFor NM group, long-term goals included improving neuromeningeal mobility and restoring function to neural structures. Each patient received the treatment for two months, with three sessions per week, each lasting about one hour. After addressing joint limitations and muscle tensions affecting radicular mobility, NM was introduced starting from the fourth week. The protocol was structured around three main axes: treatment of interfaces (joint mobilizations and traction), direct treatment (using neurodynamic techniques), and indirect treatment (neural self-mobilization and lifestyle advice). The treatment included various stages for each ULNT technique [9]. ULNT1 targeted the median nerve and involved shoulder abduction, elbow extension, and head inclination. ULNT2 focused on scapular depression and targeted cervical roots. ULNT3 emphasized radial nerve tension with internal rotation of the shoulder, while ULNT4 addressed ulnar nerve tension through elbow flexion and shoulder abduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over 18 years old
- with chronic common CBN
Key exclusion criteria (6 listed)
- secondary CBN
- prior cervical surgery
- cervical trauma
- recent central or peripheral neurological conditions
- unstable cauda equina lesions,
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 |
|---|---|---|
| conventional rehabilitationFor control group, the conventional rehabilitation protocol aimed to alleviate muscular and neuropathic pain in the short term, improve cervical mobility, reduce muscle tension, and increase muscle strength in the medium term, and promote a healthy lifestyle along with socio-professional reintegration in the long term. The principles included educating patients about their condition, respecting pain thresholds, and considering fatigue levels. Each patient received treatment for two months, with three sessions per week, each lasting about one hour. The protocol consisted of three phases: the first week focused on relaxation through massage and low-frequency electrotherapy; the second week introduced passive joint mobilizations; and from the third week, muscle stretching and strengthening exercises were incorporated. Additionally, functional exercises targeting daily activities and body awareness techniques are included to maintain proper posture. | Procedure or surgery | NM arm, control group |
| neural mobilisationThe protocol was structured around three main axes: treatment of interfaces (joint mobilizations and traction), direct treatment (using neurodynamic techniques), and indirect treatment (neural self-mobilization and lifestyle advice). The treatment included various stages for each ULNT technique. ULNT1 targeted the median nerve and involved shoulder abduction, elbow extension, and head inclination. ULNT2 focused on scapular depression and targeted cervical roots. ULNT3 emphasized radial nerve tension with internal rotation of the shoulder, while ULNT4 addressed ulnar nerve tension through elbow flexion and shoulder abduction. Each technique was executed with specific movements, maintained for 20 to 30 seconds, and repeated 15 times, followed by gentle scapular mobilizations until pain resolution. | Procedure or surgery | NM arm |
Primary outcome
pain intensity
Time frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
Pain: was assessed using the Visual Analog Scale (VAS) which ranges from 0 (no pain) to 10 (maximal imaginable pain)
3 secondary outcomes
mobility
Time frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
function
Time frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
depression
Time frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
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 8 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional rehabilitation and neural mobilisation in people with Cervico Brachialgia, run by Hopital Charles Nicolle at 1 site in Tunisia.
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 2 inclusion and 6 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 8 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 Tunisia. 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?
pain intensity (time frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).). 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 8 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.