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

August 10, 2022 updated by: Mohamed Talaat Helmy Mohamed, Assiut University

The Therapeutic Effect and Quality of Life After Local Injection of Steroid VS. Glucose 5% for Carpal Tunnel Syndrome : Double-blinded Clinical Trial

To assess pain relief and quality of life among patients with carpal tunnel syndrome after local steroid vs. glucose 5% injection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Recruiting
        • Assiut University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
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)
Drug: Dexamethasone
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
Drug: Glucose Injection
inject10 ml glucose 5% into the carpal tunnel in group B
Other Names:
  • glucose 5%
Active Comparator: Group B
26 patients we planned to inject them local glucose 5% ( 10 ml glucose) directly into the carpal tunnel in (group A)
Drug: Dexamethasone
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
Drug: Glucose Injection
inject10 ml glucose 5% into the carpal tunnel in group B
Other Names:
  • glucose 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the changes in visual analogue scale (pre - post- and follow up)
Time Frame: 14 days
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).
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up).
Time Frame: 3 months

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:

  1. Increase in cross-sectional area at the level of the pisiform bone;
  2. Increase in the flattening ratio at the level of the hook of the Hamate
  3. 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
3 months
To evaluate the effect of sonar guided steroid vs. glucose 5% injection on neurophysiological studies (pre-post and follow up).
Time Frame: 3 months

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

  1. Very mild CTS ............ .................. detected by only PWDSLD*
  2. Mild Median.................................... DML <4.5 and sensory NCV <40
  3. Moderately severe Median............. DML♦ >4.5 and <6.5 with preserved SNAP
  4. Severe Median ...............................DML >4.5 and <6.5 with absent SNAP
  5. Very severe Median....................... DML >6.5 with CMAP >0.2 mv
  6. 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Eman MH Khedr, Assiut University
  • Study Director: Khaled O Aboshaera, Assiut University
  • Study Director: Aml MA Tohami, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 11, 2022

Study Record Updates

Last Update Posted (Actual)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22151125

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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