NCT05213819

Brief Summary

Carpal tunnel syndrome (CTS) is the most common peripheral nerve compression syndrome. There is insufficient evidence about the efficacy and superiority of conservative treatment methods. The purpose of this study was to evaluate the additional contribution of phonophoresis and Low-Level Laser Therapy (LLLT) to exercise in patients with the CTS. Study design: A single-blind randomized controlled study. Methods: Forty-five patients with clinical and electrophysiologic evidence of moderate CTS were included in the study. The patients were randomized into three groups. Group 1 received phonophoresis and exercise, group 2 received LLLT and exercise and group 3 received exercise alone. All patients were evaluated electrophysiologically, clinically and ultrasonographically before treatment and 6th and 12th week after the treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2015

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

December 28, 2021

Last Update Submit

January 17, 2022

Conditions

Keywords

Carpal tunnel syndromePhonophoresisLow-Level Laser TherapyExerciseElectrophysiologicalUltrasonographical

Outcome Measures

Primary Outcomes (1)

  • Body mass index

    kg/m2

    12 weeks

Secondary Outcomes (6)

  • Duration of disease

    12 weeks

  • Sex

    12 weeks

  • The Boston Carpal Tunnel Questionnaire

    12 weeks

  • visual analog scale (VAS)

    12 weeks

  • Ultrasonographic parameters

    12 weeks

  • +1 more secondary outcomes

Study Arms (1)

Carpal tunnel syndrome

OTHER

Patients with carpal tunnel syndrome were treated with phonophoresis, low level laser therapy and exercise.

Other: Carpal Tunnel Syndrome

Interventions

Carpal tunnel syndrome

Eligibility Criteria

Age26 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age older than 18 years
  • positive Tinel's sign or positive Phalen's sign
  • pain or paresthesia in the median nerve course
  • pain or paresthesia aggravated at night
  • moderate CTS according to the American Association of Electrodiagnostic Medicine (AAEM) guidelines

You may not qualify if:

  • metabolic diseases (including diabetes mellitus, thyroid and chronic kidney diseases)
  • rheumatoid arthritis
  • wrist trauma
  • pregnancy
  • corticosteroid treatment in the last 3 months
  • physical or medical treatment in the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University, Evliya Çelebi Training and Research Hospital

Kütahya, Merkez, 10440, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesBehavior

Study Officials

  • Nazlı Karaman

    Kütahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 28, 2022

Study Start

February 20, 2013

Primary Completion

February 20, 2015

Study Completion

February 20, 2015

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Locations