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Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
Glucose Injection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring local injection, pain relief, steroid, glucose 5%

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. female or male patient > 18y
  2. mild to moderate cases of carpal tunnel syndrome according to Bland's Neurophysiological Grading Scale for Patients with CTS
  3. clear consent to participate in the study

Exclusion Criteria:

  1. age younger than 18y.
  2. severe cases of CTS.
  3. systemic diseases cause CTS .

Sites / Locations

  • Assiut University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

26 patients we planned to inject them local steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group A)

26 patients we planned to inject them local glucose 5% ( 10 ml glucose) directly into the carpal tunnel in (group A)

Outcomes

Primary Outcome Measures

the changes in visual analogue scale (pre - post- and follow up)
the changes in visual analogue scale (pre - post- and follow up) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores . pain intensity described as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).

Secondary Outcome Measures

-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up). -U/S In the literature, four criteria are used to diagnose CTS by sonography: Increase in cross-sectional area at the level of the pisiform bone; Increase in the flattening ratio at the level of the hook of the Hamate Palmar bowing of the flexor retinaculum by sonography. The above readings will be calculated and will be compared to the previous readings of the same patient of each group. eg. The grade of CTS severity was classified according to the CSA of the median nerve considering 10.0 - 12.9mm2 as mild grade, 13.0 - 15.0mm2 as moderate grade and >15.0 mm2 as severe grade
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up). Neurophysiology studies (sensory, motor conduction, and f wave of both median and ulnar nerve) Grade ............................................ EDX Abnormality Very mild CTS ............ .................. detected by only PWDSLD* Mild Median.................................... DML <4.5 and sensory NCV <40 Moderately severe Median............. DML♦ >4.5 and <6.5 with preserved SNAP Severe Median ...............................DML >4.5 and <6.5 with absent SNAP Very severe Median....................... DML >6.5 with CMAP >0.2 mv Extremely severe Median ...............CMAP from APB <0.2 mv we detect improvment in latency, amplitude and NCV after 3 months of local injection and comparing it with previous readings of the same patient of each group.

Full Information

First Posted
December 27, 2021
Last Updated
August 10, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05496764
Brief Title
Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome
Official Title
The Therapeutic Effect and Quality of Life After Local Injection of Steroid VS. Glucose 5% for Carpal Tunnel Syndrome : Double-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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

5. Study Description

Brief Summary
To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection.
Detailed Description
Carpal tunnel syndrome (CTS) is the most prevalent type of peripheral nerve entrapment involving compression of the median nerve in the carpal tunnel. 1 This condition is more common in females than in males. CTS may be unilateral or bilateral. It is a significant cause of morbidity and poor quality of life in those patients. There is deterioration in functional outcomes and maybe psychologically as well. The severity of CTS varied from mild to moderate to severe. Its signs and symptoms include numbness along with the median nerve distribution of the hand, pain, atrophy of muscles, handgrip weakness, etc. Mild or moderate cases are usually seeking conservative treatment like electrotherapeutic modalities, manual therapy interventions, oral supplements and medications, and wrist immobilizations such as splints. Severe cases are likely to go toward surgery. But most patients with CTS are reluctant to take the surgical choice, mainly because of financial issues and secondary complications. Therefore, the evaluation of the effectiveness of the non-surgical (conservative) therapies should be a major concern, as they are cost-effective and lacks secondary complications. Much research has been conducted to see the efficacy of various conservative therapies. -study method: We are going to carry out a double-blinded randomized, case-controlled study on 52 patients who are randomly chosen and categorized them into 2 groups, 26 patients each. we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group 1) and to inject 10 ml glucose 5% into the carpal tunnel for the other group (group 2).. All injections will be under sonographic guidance. Neurophysiology, U/S, pain scales, and quality of life scales studies will be performed for these two groups before treatment and after 12 weeks of injection. The patients will be followed up for 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
local injection, pain relief, steroid, glucose 5%

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The patients were randomly assigned to one of two groups. Serially numbered opaque closed envelopes were used for allocation concealment. Allocation was maintained. To ensure double blinding, the random allocation sequence was kept by one investigator different from the one who enrolled the participants or assigned them to the interventions. Moreover, a third investigator was responsible for following the patients up and for assessment.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
26 patients we planned to inject them local steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in (group A)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
26 patients we planned to inject them local glucose 5% ( 10 ml glucose) directly into the carpal tunnel in (group A)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
we planned to inject steroid( 4 mg of dexamethasone acetate combined with 1% lidocaine into the carpal tunnels) directly into the carpal tunnel in group A
Intervention Type
Drug
Intervention Name(s)
Glucose Injection
Other Intervention Name(s)
glucose 5%
Intervention Description
inject10 ml glucose 5% into the carpal tunnel in group B
Primary Outcome Measure Information:
Title
the changes in visual analogue scale (pre - post- and follow up)
Description
the changes in visual analogue scale (pre - post- and follow up) Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores . pain intensity described as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Time Frame
14 days
Secondary Outcome Measure Information:
Title
-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
Description
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up). -U/S In the literature, four criteria are used to diagnose CTS by sonography: Increase in cross-sectional area at the level of the pisiform bone; Increase in the flattening ratio at the level of the hook of the Hamate Palmar bowing of the flexor retinaculum by sonography. The above readings will be calculated and will be compared to the previous readings of the same patient of each group. eg. The grade of CTS severity was classified according to the CSA of the median nerve considering 10.0 - 12.9mm2 as mild grade, 13.0 - 15.0mm2 as moderate grade and >15.0 mm2 as severe grade
Time Frame
3 months
Title
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
Description
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up). Neurophysiology studies (sensory, motor conduction, and f wave of both median and ulnar nerve) Grade ............................................ EDX Abnormality Very mild CTS ............ .................. detected by only PWDSLD* Mild Median.................................... DML <4.5 and sensory NCV <40 Moderately severe Median............. DML♦ >4.5 and <6.5 with preserved SNAP Severe Median ...............................DML >4.5 and <6.5 with absent SNAP Very severe Median....................... DML >6.5 with CMAP >0.2 mv Extremely severe Median ...............CMAP from APB <0.2 mv we detect improvment in latency, amplitude and NCV after 3 months of local injection and comparing it with previous readings of the same patient of each group.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: female or male patient > 18y mild to moderate cases of carpal tunnel syndrome according to Bland's Neurophysiological Grading Scale for Patients with CTS clear consent to participate in the study Exclusion Criteria: age younger than 18y. severe cases of CTS. systemic diseases cause CTS .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed TH Mohamed, Resident
Phone
00201090117707
Email
mohamedtalaathelmy7@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eman MH Khedr, Professor
Phone
0020100 585 0632
Email
Emankhedr99@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman MH Khedr
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khaled O Aboshaera
Organizational Affiliation
Assiut University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aml MA Tohami
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman MH Khedr, Professor
Phone
0020100 585 0632
Email
Emankhedr99@yahoo.com

12. IPD Sharing Statement

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Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome

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