NCT06493617

Brief Summary

All Double Crush Syndrome patients were assessed via VAS, BCTQ \& Nerve conduction study before and after the treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 2, 2024

Last Update Submit

July 11, 2024

Conditions

Keywords

cervical mobilizationhand functiondouble crush syndrome

Outcome Measures

Primary Outcomes (3)

  • Visual analogue scale

    Used to assess degree of pain

    4 weeks

  • Boston carpal tunnel syndrome questionnaire

    Used to assess patients' functional ability and symptoms severity

    4 weeks

  • Nerve conduction study

    Used to assess sensory and motor fibers of median nerve to determine the improvement in nerve capacity and hand function

    4 weeks

Study Arms (2)

Control Group

EXPERIMENTAL

received a standard physical therapy program of nerve glide, hand strengthening exercise and mobilization

Other: Traditional physical therapy treatment

Study Group

EXPERIMENTAL

received a cervical mobilization in addition to the standard physical therapy program for 12 sessions

Other: Cervical MobilizationOther: Traditional physical therapy treatment

Interventions

The technique is used to mobilize a specific cervical or upper thoracic segment (C2-C3 through T3-T4) in a posterior to anterior direction. The therapist gently applies pressure in an anteroposterior direction in the plane of the facet joint to assess mobility, resistance, end feel, and pain provocation. Gentle oscillations can be used to either inhibit pain (grades I and II) or restore motion (grades III and IV). Slight variations in depth and direction of force can be used to optimize the therapeutic effects of this technique.

Study Group

tendon gliding exercises, median nerve gliding exercise, strengthening exercises for 60 minutes

Control GroupStudy Group

Eligibility Criteria

Age25 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Thirty female patients diagnosed as Double Crush Syndrome based on the clinical diagnostic criteria of the American Academy of Neurology, (American Academy of Neurology 2019).
  • Patient ages ranged from 25 to 35 years old. Patient who reported pain, hyperesthesia, and/or paresthesia at the course of median nerve distribution and upper limb.
  • A Nerve Conduction Study (NCS) evidence of peripheral entrapment of median nerve at level of carpal bone "Carpal tunnel Syndrome" with a fractionated sensory nerve conduction velocity for the median nerve across the wrist of 40 m/s or less and with sensory peak latency \> 3.6 ms and recordable and with motor distal latency \>4.4 ms and less than 6.5ms.

You may not qualify if:

  • Patients had Systemic disease causes double Crush Syndrome as rheumatoid arthritis (RA), thyroid disease, Diabetes mellitus (DM), Pregnant women, Patients with concomitant neurological disease as peripheral neuropathy, Patients with history of wrist surgery, fracture, or carpal tunnel injection in the last two weeks before the study, Patients who have wasting of the thenar muscles, Patients with previous surgery for CTS.
  • Patients with complete conduction block on EDX or previous regular exposure to hand-held vibrating tools, Patients with Nerve Conduction Study with motor distal latency \> 6.5 ms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Ryada University for Science and Technology

Sadat, Menoufia, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Neurology and it's Surgery

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

August 2, 2022

Primary Completion

August 5, 2023

Study Completion

January 8, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations