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

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05496764

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Drug: Dexamethasone Drug: Glucose Injection	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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%

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%

Outcome Measures

Primary Outcome Measures

the changes in visual analogue scale (pre - post- and follow up) [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).

Secondary Outcome Measures

-To evaluate the effect of sonar guided steroid vs. glucose 5% injection on U/S (pre-post and follow up). [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: 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). [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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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