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Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS

Primary Purpose

Carpal Tunnel Syndrome, Tenosynovitis

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
local injection
extracorporeal shock wave therapy
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring extracorporeal shock wave therapy, corticosteroid injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG.
  2. Patients who are able to understand and correctly understand the patient information form
  3. Patients consenting to participate in the study according to the informed consent form

Exclusion Criteria:

  1. Cervical radiculopathy
  2. Polyneuropathy
  3. Brachial plexopathy
  4. Systemic corticosteroid treatment
  5. Fracture and trauma history of the treated side anterior arm and wrist
  6. Inflammatory rheumatic disease
  7. Pregnant and lactating patients
  8. Patients with cardiac pacemakers
  9. Patients undergoing carpal tunnel syndrome surgery
  10. Thoracic outlet syndrome
  11. Severe atrophy
  12. Severe carpal tunnel syndrome
  13. Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient,
  14. Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder

Sites / Locations

  • Ahi Evran University Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

extracorporeal shock wave therapy

local injection

carpal tunnel wrist brace

Arm Description

ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) - Pain
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.
Visual Analog Scale (VAS) - Numbness
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.

Secondary Outcome Measures

hand clamping force
Hand grip strength measurement using Jamar hydraulic hand dynamometer. Hand grip strength measurements will be performed using the elbow at 90 degrees of flexion, while the forearm and wrist is in neutral position using resistance at level 2. Measurements shall be performed three times, and the average result shall be recorded in kilograms (kg) for each hand separately.
boston scale
Boston symptom severity score(SSS) and improvement in functional status score(FSS). There are 11 questions at SSS. Responses vary from 'none(1 point)' to 'very severe(5 points)'. There are 8 questions in FSS. Responses vary from 'very easy (1 point)' to 'very difficult (5 points) according to difficulty level. In both scales, the degree of symptom severity and dysfunction increases as the total score increases.The score of the patient is divided by the total score (total score is 11x5 = 55 for the SSS and the total score is 8x5 = 40 for FSS) and 0 to 1 for each patient. As this ratio reaches 1, the degree of symptom severity and dysfunction of the patient increases. For example; Considering that the total score obtained from all the questions in the SPS is 22, the ratio of 22/55 = 0. 4 is obtained.These scales will be applied after treatment and the rates obtained before and after treatment will be compared.
Median nerve sensory distal latency(electrophysiological examination,physiological parameter)
Evaluation of median nerve sensory distal latency: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. On EMG examination, sensory distal latency was greater than 3.6 ms and CTS was accepted.
Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)
Evaluation of median nerve sensory transmission rate: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. Emotional nerve conduction velocity lower than 50 m/s in EMG examination will be accepted as CTS.
Median nerve motor distal latency( electrophysiological examination, physiological parameter)
Evaluation of median nerve motor distal latency : The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. In the EMG examination, if the motor distal latency is over 4.2 ms, CTS will be accepted.
Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)
Evaluation of median nerve motor transmission rate: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist.
Median sensory nerve action potential amplitude
Evaluation of Median sensory nerve action potential amplitude: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. In the emg examination, the median sensory nerve action potential amplitude below 10 microvolts will be accepted as CTS.
Compound muscle action potential amplitude
Evaluation of compound muscle action potential amplitude: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. The median CBAP amplitude below 5 millivolt in the recording of APB muscle in the emg examination will be accepted as CTS.

Full Information

First Posted
December 7, 2018
Last Updated
April 24, 2020
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03792945
Brief Title
Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS
Official Title
Comparison of the Efficacy of Corticosteroid Injection and Extracorporeal Shock Wave Therapy (ESWT) in Patients With Carpal Tunnel Syndrome; A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
May 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection in patients with carpal tunnel syndrome(CTS) compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. 90 idiopathic moderate and mild CTS patients will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded.The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once. And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.
Detailed Description
In this study, the investigators aimed to demonstrate the efficacy of ESWT (extracorporeal shock wave therapy) and local corticosteroid injection compared to participants receiving only splint and exercise therapy. And the investigators wanted to show that ESWT, a noninvasive treatment modality, is as effective and reliable as local corticosteroid injection, which is the least invasive treatment. Mild and moderate CTS patients will be determined according to American Association of Electrodiagnostic Medicine (AAEM) criteria. Cervical radiculopathy, polyneuropathy, brachial plexopathy, systemic corticosteroid treatment, fracture and trauma history of the treated side anterior arm and wrist, inflammatory rheumatic disease, pregnant and lactating participants, participants with cardiac pacemakers, participants undergoing carpal tunnel syndrome surgery, thoracic outlet syndrome, severe atrophy, severe carpal tunnel syndrome, participants who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the participants is not in favor of the participants, systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder will be excluded.90 idiopathic moderate and mild CTS participants will be included in the study. The participants will be informed about their participation in a study and written informed consent will be obtained.The demographic characteristics and disease duration of the participants will be recorded. The participants will be randomly divided into 3 groups.40 mg of local methylprednisolone (depomedrol) injection will be applied to Group 1 once. And group 1 will also be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. ESWT will be applied to Group 2 once a week for a total of 3 weeks and hand wrist rest splints will be given for 3 months especially at night when it is not in use. Group 3 (control group) will be given a hand wrist rest splint to use for 3 months, especially at night, when not using the hand. The evaluations will be repeated before treatment, after the first week after treatment (first ESWT application) and at the 3rd month. Hand grip strength measurement will be performed using Boston carpal tunnel syndrome questionnaire, visual analog scale and dynamometer. Electromyogram (EMG) data will be recorded before and 3 months after treatment. During the trial, the routine will not be excluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Tenosynovitis
Keywords
extracorporeal shock wave therapy, corticosteroid injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
extracorporeal shock wave therapy
Arm Type
Active Comparator
Arm Description
ESWT will be applied to Group 1 once a week for a total of 3 weeks. Modus ESWT device will be used. The patient's wrist will be applied at a pressure of 4 bar and 2000 Hz at a frequency of 5 Hz. Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.
Arm Title
local injection
Arm Type
Active Comparator
Arm Description
40 mg of local Depomedrol (methylprednisolone) injection will be applied to group 2 once. Injection will be made from wrist with carpal tunnel syndrome.Patients will be given a splint at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.
Arm Title
carpal tunnel wrist brace
Arm Type
No Intervention
Arm Description
Patients will be given a carpal tunnel wrist brace at night and when they do not use their hands during the day. Participants will use the carpal tunnel wrist brace 3 months.
Intervention Type
Drug
Intervention Name(s)
local injection
Other Intervention Name(s)
local corticosteroid injection
Intervention Description
In addition to the local injection, carpal tunnel brace will be given.
Intervention Type
Device
Intervention Name(s)
extracorporeal shock wave therapy
Other Intervention Name(s)
physiotheraphy
Intervention Description
In addition to all ESWT participants, carpal tunnel brace will be given.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) - Pain
Description
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line.The participant is asked to mark the point indicating his/her status on this line.The patient marks his current state on this line.The length of the distance from where the pain is no longer to the point marked by the patient indicates the pain of the patient.The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10.The distance of the point marked by the participant is measured in millimeters.And divided into 10.This value gives the participant's pain score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad. The scale has no subscales and total score.
Time Frame
3. months after treatment
Title
Visual Analog Scale (VAS) - Numbness
Description
VAS is used to digitize some values that cannot be measured numerically.Two ends of the parameter to be evaluated are written on both ends of a 100 mm line. The participant is asked to mark the point indicating his / her status on this line. The patient marks his current state on this line. The length of the distance from where the numbness is no longer to the point marked by the patient indicates the numbness of the patient. The values obtained before and after treatment will be compared.The starting point of the graph is zero and the end point is 10. The distance of the point marked by the participant is measured in millimeters. And divided into 10. This value gives the participant's numbness score.For example, if the point marked by the participant is 50 mm, it will get 50/10 = 5 points.Increasing the score of the participant means that the complaint is too high and the result is bad.The scale has no subscales and total score.
Time Frame
3. months after treatment
Secondary Outcome Measure Information:
Title
hand clamping force
Description
Hand grip strength measurement using Jamar hydraulic hand dynamometer. Hand grip strength measurements will be performed using the elbow at 90 degrees of flexion, while the forearm and wrist is in neutral position using resistance at level 2. Measurements shall be performed three times, and the average result shall be recorded in kilograms (kg) for each hand separately.
Time Frame
3. months after treatment
Title
boston scale
Description
Boston symptom severity score(SSS) and improvement in functional status score(FSS). There are 11 questions at SSS. Responses vary from 'none(1 point)' to 'very severe(5 points)'. There are 8 questions in FSS. Responses vary from 'very easy (1 point)' to 'very difficult (5 points) according to difficulty level. In both scales, the degree of symptom severity and dysfunction increases as the total score increases.The score of the patient is divided by the total score (total score is 11x5 = 55 for the SSS and the total score is 8x5 = 40 for FSS) and 0 to 1 for each patient. As this ratio reaches 1, the degree of symptom severity and dysfunction of the patient increases. For example; Considering that the total score obtained from all the questions in the SPS is 22, the ratio of 22/55 = 0. 4 is obtained.These scales will be applied after treatment and the rates obtained before and after treatment will be compared.
Time Frame
3. months after treatment
Title
Median nerve sensory distal latency(electrophysiological examination,physiological parameter)
Description
Evaluation of median nerve sensory distal latency: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. On EMG examination, sensory distal latency was greater than 3.6 ms and CTS was accepted.
Time Frame
3. months after treatment
Title
Median nerve sensory transmission rate( electrophysiological examination, physiological parameter)
Description
Evaluation of median nerve sensory transmission rate: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. Emotional nerve conduction velocity lower than 50 m/s in EMG examination will be accepted as CTS.
Time Frame
3. months after treatment
Title
Median nerve motor distal latency( electrophysiological examination, physiological parameter)
Description
Evaluation of median nerve motor distal latency : The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. In the EMG examination, if the motor distal latency is over 4.2 ms, CTS will be accepted.
Time Frame
3. months after treatment
Title
Median nerve motor transmission rate ( electrophysiological examination, physiological parameter)
Description
Evaluation of median nerve motor transmission rate: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist.
Time Frame
3. months after treatment
Title
Median sensory nerve action potential amplitude
Description
Evaluation of Median sensory nerve action potential amplitude: Active and reference electrodes in the form of superficial electrodes will be placed in the metacarpophalangial and distal interphalangial joints of the 2nd finger. In the emg examination, the median sensory nerve action potential amplitude below 10 microvolts will be accepted as CTS.
Time Frame
3. months after treatment
Title
Compound muscle action potential amplitude
Description
Evaluation of compound muscle action potential amplitude: The patient will be stretched in the supine position with the arm extended, the palm facing up.The active recording electrode will be connected to the middle point of the abductor pollicis brevis (APB), the reference electrode to the thumb, the ground electrode to the flexor face of the forearm.The first warning will be given by the ulnar of the brachial artery pulse from the proximal 5 cm proximal part of the active electrode to the wrist. The median CBAP amplitude below 5 millivolt in the recording of APB muscle in the emg examination will be accepted as CTS.
Time Frame
3. months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women and male patients with carpal tunnel syndrome, tendinitis, tenosynovitis diagnosed between 18-65 years of age with clinical and EMG. Patients who are able to understand and correctly understand the patient information form Patients consenting to participate in the study according to the informed consent form Exclusion Criteria: Cervical radiculopathy Polyneuropathy Brachial plexopathy Systemic corticosteroid treatment Fracture and trauma history of the treated side anterior arm and wrist Inflammatory rheumatic disease Pregnant and lactating patients Patients with cardiac pacemakers Patients undergoing carpal tunnel syndrome surgery Thoracic outlet syndrome Severe atrophy Severe carpal tunnel syndrome Patients who are unwilling or unable to participate for any reason, and those who have been decided by the clinician that the patient is not in favor of the patient, Systemic diseases such as renal failure, peptic ulcer, dm, hypothyroidism, coagulation disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havva ÖZTÜRK DURMAZ
Organizational Affiliation
Ahi Evran University Education and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahi Evran University Education and Research Hospital
City
Kırşehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35706121
Citation
Ozturk Durmaz H, Tuncay F, Durmaz H, Erdem HR. Comparison of Radial Extracorporeal Shock Wave Therapy and Local Corticosteroid Injection Effectiveness in Patients With Carpal Tunnel Syndrome: A Randomized Controlled Study. Am J Phys Med Rehabil. 2022 Jul 1;101(7):685-692. doi: 10.1097/PHM.0000000000001891. Epub 2021 Oct 4.
Results Reference
derived

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Comparison of the Efficacy of Corticosteroid Injection and ESWT in Patients With CTS

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