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
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
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 .
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
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
Citations:
PubMed Identifier
28075090
Citation
Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.
Results Reference
background
PubMed Identifier
31209710
Citation
Kamel SR, Sadek HA, Hamed A, Sayed OA, Mahmud MH, Mohamed FA, El Sagher GM, Aly LH. Ultrasound-guided insulin injection for carpal tunnel syndrome in type 2 diabetes mellitus patients. Clin Rheumatol. 2019 Oct;38(10):2933-2940. doi: 10.1007/s10067-019-04638-7. Epub 2019 Jun 17.
Results Reference
background
PubMed Identifier
19534294
Citation
Ashraf A, Moghtaderi AR, Yazdani AH, Mirshams S. Evaluation of effectiveness of local insulin injection in non-insulin-dependent diabetic patient with carpal tunnel syndrome. Electromyogr Clin Neurophysiol. 2009 May-Jun;49(4):161-6.
Results Reference
background
PubMed Identifier
26173490
Citation
Pourmemari MH, Shiri R. Diabetes as a risk factor for carpal tunnel syndrome: a systematic review and meta-analysis. Diabet Med. 2016 Jan;33(1):10-6. doi: 10.1111/dme.12855. Epub 2015 Aug 18.
Results Reference
background
Citation
Nakandala, Piumi. (2019). International Journal of Advanced Research and Publications Manual Therapy Interventions For Carpal Tunnel Syndrome: A Review. 3. 88-96.
Results Reference
background
PubMed Identifier
3519887
Citation
Recio-Pinto E, Rechler MM, Ishii DN. Effects of insulin, insulin-like growth factor-II, and nerve growth factor on neurite formation and survival in cultured sympathetic and sensory neurons. J Neurosci. 1986 May;6(5):1211-9. doi: 10.1523/JNEUROSCI.06-05-01211.1986.
Results Reference
background
PubMed Identifier
26019423
Citation
Kanikannan MA, Boddu DB, Umamahesh, Sarva S, Durga P, Borgohain R. Comparison of high-resolution sonography and electrophysiology in the diagnosis of carpal tunnel syndrome. Ann Indian Acad Neurol. 2015 Apr-Jun;18(2):219-25. doi: 10.4103/0972-2327.150590.
Results Reference
background
PubMed Identifier
19687086
Citation
Mody GN, Anderson GA, Thomas BP, Pallapati SC, Santoshi JA, Antonisamy B. Carpal tunnel syndrome in Indian patients: use of modified questionnaires for assessment. J Hand Surg Eur Vol. 2009 Oct;34(5):671-8. doi: 10.1177/1753193409101469. Epub 2009 Aug 17.
Results Reference
background
PubMed Identifier
1593914
Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Results Reference
background
PubMed Identifier
30194626
Citation
Arian M, Mirmohammadkhani M, Ghorbani R, Soleimani M. Health-related quality of life (HRQoL) in beta-thalassemia major (beta-TM) patients assessed by 36-item short form health survey (SF-36): a meta-analysis. Qual Life Res. 2019 Feb;28(2):321-334. doi: 10.1007/s11136-018-1986-1. Epub 2018 Sep 7.
Results Reference
background
PubMed Identifier
11323136
Citation
Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
Results Reference
background
PubMed Identifier
28850536
Citation
Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.
Results Reference
background
PubMed Identifier
12914662
Citation
Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
Results Reference
background
PubMed Identifier
34394615
Citation
Sharour LA, Omari OA, Salameh AB, Yehia D. Health-related quality of life among patients with colorectal cancer. J Res Nurs. 2020 Mar;25(2):114-125. doi: 10.1177/1744987119846177. Epub 2019 Aug 22.
Results Reference
background
PubMed Identifier
15155897
Citation
Wong SM, Griffith JF, Hui AC, Lo SK, Fu M, Wong KS. Carpal tunnel syndrome: diagnostic usefulness of sonography. Radiology. 2004 Jul;232(1):93-9. doi: 10.1148/radiol.2321030071. Epub 2004 May 20.
Results Reference
background
PubMed Identifier
12913205
Citation
Kele H, Verheggen R, Bittermann HJ, Reimers CD. The potential value of ultrasonography in the evaluation of carpal tunnel syndrome. Neurology. 2003 Aug 12;61(3):389-91. doi: 10.1212/01.wnl.0000073101.04845.22.
Results Reference
background
PubMed Identifier
10918269
Citation
Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. doi: 10.1002/1097-4598(200008)23:83.0.co;2-y.
Results Reference
background
Citation
Subandi, S., Mirawati, D., Erdana Putra, S., Hafizhan, M., Susilo, W. and Danuaji, R., 2020. THE RELATIONSHIP BETWEEN WORKING PERIOD OF BATIK CRAFTSMEN AND INCIDENT OF CARPAL TUNNEL SYNDROME. MNJ (Malang Neurology Journal), 6(2), pp.73-76
Results Reference
background
PubMed Identifier
31742366
Citation
Ezzati K, Laakso EL, Saberi A, Yousefzadeh Chabok S, Nasiri E, Bakhshayesh Eghbali B. A comparative study of the dose-dependent effects of low level and high intensity photobiomodulation (laser) therapy on pain and electrophysiological parameters in patients with carpal tunnel syndrome. Eur J Phys Rehabil Med. 2020 Dec;56(6):733-740. doi: 10.23736/S1973-9087.19.05835-0. Epub 2019 Nov 18.
Results Reference
background
PubMed Identifier
28334999
Citation
Maeda Y, Kim H, Kettner N, Kim J, Cina S, Malatesta C, Gerber J, McManus C, Ong-Sutherland R, Mezzacappa P, Libby A, Mawla I, Morse LR, Kaptchuk TJ, Audette J, Napadow V. Rewiring the primary somatosensory cortex in carpal tunnel syndrome with acupuncture. Brain. 2017 Apr 1;140(4):914-927. doi: 10.1093/brain/awx015.
Results Reference
background
PubMed Identifier
18386719
Citation
Niempoog S, Sanguanjit P, Waitayawinyu T, Angthong C. Local injection of dexamethasone for the treatment of carpal tunnel syndrome in pregnancy. J Med Assoc Thai. 2007 Dec;90(12):2669-76.
Results Reference
background
PubMed Identifier
29667082
Citation
Sung YT, Wu JS. The Visual Analogue Scale for Rating, Ranking and Paired-Comparison (VAS-RRP): A new technique for psychological measurement. Behav Res Methods. 2018 Aug;50(4):1694-1715. doi: 10.3758/s13428-018-1041-8.
Results Reference
background
Learn more about this trial
Local Injection of Steroid VS.Glucose 5% in Carpal Tunnel Syndrome
We'll reach out to this number within 24 hrs