NCT06913062

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

cervico-brachial neuralgianeural mobilizationpainfunction

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    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 Outcomes (3)

  • mobility

    Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).

  • function

    Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).

  • depression

    Outcome measures were collected at baseline prior to the intervention (T0) and at the end of the treatment period (T1).

Study Arms (2)

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.

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

Procedure: conventional rehabilitationProcedure: neural mobilisation

Interventions

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.

NM armcontrol group

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.

NM arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients over 18 years old
  • with chronic common CBN

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunisia

Location

MeSH Terms

Conditions

Brachial Plexus NeuritisPain

Condition Hierarchy (Ancestors)

Brachial Plexus NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuritisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

January 2, 2024

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations