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Trial record 16 of 22 for:    "Nerve Compression Syndrome" | "Hormones"

Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02652390
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Isam Atroshi, Region Skane

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Carpal Tunnel Syndrome
Interventions Drug: Methylprednisolone 80 mg
Drug: Methylprednisolone 40 mg
Other: Saline
Enrollment 111
Recruitment Details This is a long-term follow-up of patients who participated in a randomized trial. In the initial trial the patients were recruited between November 7, 1998 and March 10, 2011 (NCT00806871; see Atroshi et al. Ann Intern Med 2013). Data in this follow-up were collected between February 24, 2016 and July 7, 2016.
Pre-assignment Details No significant events occurred after participant enrollment but prior to assignment to arms.
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Period Title: Overall Study
Started 37 37 37
Completed 37 37 37
Not Completed 0 0 0
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo Total
Hide Arm/Group Description

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Total of all reporting groups
Overall Number of Baseline Participants 37 37 37 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 37 participants 111 participants
53  (12) 50  (11) 55  (12) 53  (12)
[1]
Measure Description: Age at follow-up
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 37 participants 111 participants
Female
26
  70.3%
27
  73.0%
28
  75.7%
81
  73.0%
Male
11
  29.7%
10
  27.0%
9
  24.3%
30
  27.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 37 participants 111 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
37
 100.0%
37
 100.0%
37
 100.0%
111
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 37 participants 37 participants 37 participants 111 participants
37 37 37 111
Dominant hand treated  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 37 participants 111 participants
30
  81.1%
29
  78.4%
28
  75.7%
87
  78.4%
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 37 participants 37 participants 37 participants 111 participants
27.3  (4.2) 27.6  (4.3) 27.7  (5.7) 27.5  (4.8)
[1]
Measure Description: BMI at follow-up
Follow-up time from randomization/treatment  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 37 participants 37 participants 37 participants 111 participants
74  (7.5) 74  (7.1) 74  (7.1) 74  (7.2)
1.Primary Outcome
Title Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand
Hide Description Number of patients who have had carpal tunnel release surgery on the study hand.
Time Frame 5 to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all trial participants were available with no withdrawals, drop-outs or missing data.
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description:

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Overall Number of Participants Analyzed 37 37 37
Measure Type: Count of Participants
Unit of Measure: Participants
31
  83.8%
34
  91.9%
36
  97.3%
2.Primary Outcome
Title Symptom Severity Score
Hide Description Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).
Time Frame 5-7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 80-mg Mrthylprednisolone and no Surgery Surgery After Methylprednisolone or Placebo
Hide Arm/Group Description:
Patients in the 80-mg methylprednisolone group who had not undergone carpal tunnel release surgery on the study hand
Patients in the methylprednisolone or placebo groups who had undergone carpal tunnel release surgery after injection.
Overall Number of Participants Analyzed 6 101
Mean (Standard Deviation)
Unit of Measure: score on a scale
1.34  (0.9) 1.53  (0.9)
3.Secondary Outcome
Title Palmar Pain Score
Hide Description Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
Time Frame 5-7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description:

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Overall Number of Participants Analyzed 37 37 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
86.4  (18) 84.6  (22) 83.0  (25)
4.Secondary Outcome
Title 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score
Hide Description Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
Time Frame 5-7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description:

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Overall Number of Participants Analyzed 37 37 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
13.1  (18) 16.9  (20) 19.3  (20)
5.Secondary Outcome
Title Bodily Pain Score
Hide Description Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
Time Frame 5-7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description:

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Overall Number of Participants Analyzed 37 37 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
81.4  (24) 79.9  (24) 78.2  (25)
6.Secondary Outcome
Title Satisfaction Score
Hide Description Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
Time Frame 5-7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description:

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

Overall Number of Participants Analyzed 37 37 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
77.5  (28) 71.4  (27) 68.4  (28)
Time Frame 5 to 7 years
Adverse Event Reporting Description Adverse events from patient-reporting and review of medical records.
 
Arm/Group Title Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Hide Arm/Group Description

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Methylprednisolone 40 mg: 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Local injection of saline into the carpal tunnel

Saline: 2 mL saline + 1 mL lidocaine

All-Cause Mortality
Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%)   0/37 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%)   0/37 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Methylprednisolone 80 mg Methylprednisolone 40 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/37 (0.00%)   0/37 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Isam Atroshi
Organization: Hässleholm Hospital, Hässleholm, Sweden
Phone: +46443091260
EMail: Isam.Atroshi@skane.se
Layout table for additonal information
Responsible Party: Isam Atroshi, Region Skane
ClinicalTrials.gov Identifier: NCT02652390     History of Changes
Other Study ID Numbers: HLM_CTS_2
First Submitted: January 8, 2016
First Posted: January 11, 2016
Results First Submitted: September 6, 2018
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018