NCT05496764

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

December 27, 2021

Last Update Submit

August 10, 2022

Conditions

Carpal Tunnel Syndrome

Keywords

local injectionpain reliefsteroidglucose 5%

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • -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 neurophysiological studies (pre-post and follow up).

    3 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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: DexamethasoneDrug: Glucose Injection

Group B

ACTIVE COMPARATOR

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

Drug: DexamethasoneDrug: Glucose Injection

Interventions

DexamethasoneDRUG

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

Group AGroup B
Glucose InjectionDRUG

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

Also known as: glucose 5%
Group AGroup B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • age younger than 18y.
  • severe cases of CTS.
  • systemic diseases cause CTS .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71511, Egypt

RECRUITING

Related Publications (22)

  • Wipperman J, Goerl K. Carpal Tunnel Syndrome: Diagnosis and Management. Am Fam Physician. 2016 Dec 15;94(12):993-999.

    PMID: 28075090BACKGROUND

  • 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.

    PMID: 31209710BACKGROUND

  • 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.

    PMID: 19534294BACKGROUND

  • 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.

    PMID: 26173490BACKGROUND

  • Nakandala, Piumi. (2019). International Journal of Advanced Research and Publications Manual Therapy Interventions For Carpal Tunnel Syndrome: A Review. 3. 88-96.

    BACKGROUND

  • 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.

    PMID: 3519887BACKGROUND

  • 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.

    PMID: 26019423BACKGROUND

  • 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.

    PMID: 19687086BACKGROUND

  • 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.

    PMID: 1593914BACKGROUND

  • 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.

    PMID: 30194626BACKGROUND

  • 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.

    PMID: 11323136BACKGROUND

  • 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.

    PMID: 28850536BACKGROUND

  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PMID: 12914662BACKGROUND

  • 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.

    PMID: 34394615BACKGROUND

  • 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.

    PMID: 15155897BACKGROUND

  • 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.

    PMID: 12913205BACKGROUND

  • 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.

    PMID: 10918269BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 31742366BACKGROUND

  • 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.

    PMID: 28334999BACKGROUND

  • 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.

    PMID: 18386719BACKGROUND

  • 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.

    PMID: 29667082BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

DexamethasoneGlucose

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Eman MH Khedr

    Assiut University

    STUDY DIRECTOR

  • Khaled O Aboshaera

    Assiut University

    STUDY DIRECTOR

  • Aml MA Tohami

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohamed TH Mohamed, Resident

CONTACT

00201090117707mohamedtalaathelmy7@gmail.com

Eman MH Khedr, Professor

CONTACT

0020100 585 0632Emankhedr99@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2021

First Posted

August 11, 2022

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

August 11, 2022

Record last verified: 2022-08

Locations

EG(1)