- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06913062
Neural Mobilization in Cervico-Brachial Neuralgia (NM-CBN)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tunis, Tunisia
- Charles Nicolle Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
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.
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
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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