NCT05931731

Brief Summary

this study will be conducted to compare between mechanical interference and neural mobilization on ulnar neuropathy post-cubital tunnel syndrome

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 1, 2023

Conditions

Keywords

mechanical interferenceneural mobilizationulnar neuropathypost cubital syndrome

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    pain will be measured by visual analogue scale. it is a vertical or horizontal 100mm line graduated by different level of pain, starting from 0 (no pain) till 100 (worst pain).

    up to four weeks

Secondary Outcomes (3)

  • function and severity

    up to four weeks

  • ulnar nerve sensory conduction velocity

    up to four weeks

  • ulnar nerve motor distal latency

    up to four weeks

Study Arms (3)

Mechanical interference

EXPERIMENTAL

the patients will receive mechanical interference and conventional treatment three times a week for four weeks

Other: Mechanical interferenceOther: conventional treatment

Neural mobilization

EXPERIMENTAL

the patients will receive neural mobilization and conventional treatment three times a week for four weeks

Other: Neural mobilizationOther: conventional treatment

conventional treatment

ACTIVE COMPARATOR

the patients will receive conventional treatment only three times a week for four weeks

Other: conventional treatment

Interventions

The patients will receive mechanical interference treatment in the form of five techniques, including wrist distraction (3 sets for 3 minutes), rhythmic and gentle stretching of the transverse carpal ligaments, the release of palmar hand fascia, gliding of the finger flexor tendons (using the oscillatory flexion-extension movement of the metacarpophalangeal joint) and release of the upper forearm muscle and fascia were applied. Manual techniques were performed total of 15 minutes in each session each technique included 3 sets for 3 minutes and conventional treatment

Mechanical interference

the patients will receive neurodynamic mobilizations, including sliding techniques and tensioning techniques which are thought to enhance ulnar nerve gliding and restore neural tissue mobility and conventional treatment

Neural mobilization

the patients will receive therapeutic ultrasound (frequency of 1 MHz, intensity of 1 W/cm2, for 5 minutes), transcutaneous electrical nerve stimulation (TENS) (frequency of 80 Hz, pulse duration of 60 μs, at the level of comfortable tingling sensation, for 20 minutes) and therapeutic exercises.

Mechanical interferenceNeural mobilizationconventional treatment

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients were diagnosed and referred by an orthopedist.
  • The patient's age ranged from 20 to 55 years old.
  • Recent NCV for ulnar nerve confirming the diagnosis.
  • Unilateral cubital tunnel syndrome with ulnar neuropathy

You may not qualify if:

  • Patients with cervical brachialgia.
  • Patients with metabolic diseases such as diabetes, severe thyroid disorders, anemia, and -pregnancy.
  • Hypertensive patients or patients who had a previous hand or elbow surgery.
  • Patients with median nerve involvement in proximal areas such as thoracic outlet syndrome.
  • History of carpal tunnel release surgery. Steroid injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cubital Tunnel SyndromeUlnar Neuropathies

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesUlnar Nerve Compression SyndromesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: mechanical interference and neural mobilization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator mohamed tarek mohamed hefnawy

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 5, 2023

Study Start

June 30, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07