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

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496764
• Other study ID #: 22151125
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2021
• Est. completion date: January 2023

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: Mohamed TH Mohamed, Resident
• Phone: 00201090117707
• Email: mohamedtalaathelmy7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• Glucose Injection
inject10 ml glucose 5% into the carpal tunnel in group B

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	14 days
Secondary	-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	3 months
Secondary	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.	3 months