Neural Mobilization in Cervico-Brachial Neuralgia (NM-CBN)

April 4, 2025 updated by: Selma Bouden, Hopital Charles Nicolle

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Charles Nicolle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients over 18 years old
  • with chronic common CBN

Exclusion Criteria:

  • secondary CBN
  • prior cervical surgery
  • cervical trauma
  • recent central or peripheral neurological conditions
  • unstable cauda equina lesions,
  • untreated tumors or infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
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.
Procedure: conventional rehabilitation
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.
Experimental: NM arm
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
Procedure: conventional rehabilitation
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.
Procedure: neural mobilisation
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mobility
Time Frame: Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).
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
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).
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)
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).
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
Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Charles Nicolle

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECR-OMG-2024-302
  • ECR-OMG-2024-303 (Other Identifier: Charles Nicolle Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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