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Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.
Extended follow-up protocol:
All 111 trial participants will be contacted by telephone by a researcher and given information about this extended follow-up. A questionnaire together with written information and consent forms will be sent by mail. The questionnaire consists of the CTS symptom severity sale, 11-item DASH scale, bodily pain scale, and a treatment satisfaction visual analog scale (VAS), that were used in previous follow-up evaluations. The questionnaire will also include the 6-item CTS symptoms scale (CTS-6) and the palmar pain scale. The patients will be asked whether and when they had undergone carpal tunnel release surgery on the study hand after they received the injection within the trial. Patients' records will be reviewed to verify data about subsequent surgery on the study hand.
The Chi-square test will be used to compare the 80-mg methylprednisolone group and the placebo group with regard to the proportion of patients who have had carpal tunnel release surgery on the study hand within 5 years after injection (primary outcome). The change in symptom severity score in patients in the 80-mg methylprednisolone group who did not have surgery on the study hand after injection will be compared with the change in symptom severity score in patients who had surgery on the study hand after methylprednisolone injection (co-primary outcome) using analysis of covariance (ANCOVA) adjusting for sex, age, dominance of the study hand and baseline symptom severity score. A similar comparison will be made for the 11-item DASH and the bodily pain scores. The palmar pain score at 5 to 7 years will be compared between the groups using the independent-samples t-test and also ANCOVA to adjust for sex, age and dominance of the study hand. Patients who had surgery after methylprednisolone injection will be compared with patients who had surgery after placebo injection with regard to change from baseline to 5 to 7 years in the symptom severity score, 11-item DASH scale score, bodily pain score and satisfaction score using ANCOVA adjusting for sex, age, dominance of the study hand and respective baseline score. To identify potential predictive factors for long-term benefit after 80 mg methylprednisolone injection, surgery within 5 years will be analyzed according to the variables sex, age, dominance of the study hand, baseline symptom severity score (≥3 versus < 3) and baseline median nerve conduction abnormality (severe/moderate vs mild/normal).
All statistical tests will be 2-sided and a p value of less than 0.05 will indicate statistical significance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone 80 mg | Experimental | Local injection of 80 mg Methylprednisolone into the carpal tunnel |
|
| Methylprednisolone 40 mg | Experimental | Local injection of 40 mg Methylprednisolone into the carpal tunnel |
|
| Placebo | Placebo Comparator | Local injection of saline into the carpal tunnel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone 80 mg | Drug | 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | Number of patients who have had carpal tunnel release surgery on the study hand. | 5 to 7 years |
| Symptom Severity Score | Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). | 5-7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Palmar Pain Score | Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). | 5-7 years |
| 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24026316 | Result | Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome: a randomized, placebo-controlled trial. Ann Intern Med. 2013 Sep 3;159(5):309-17. doi: 10.7326/0003-4819-159-5-201309030-00004. | |
| 34677593 | Derived | Hofer M, Ranstam J, Atroshi I. Extended Follow-up of Local Steroid Injection for Carpal Tunnel Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2130753. doi: 10.1001/jamanetworkopen.2021.30753. |
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No significant events occurred after participant enrollment but prior to assignment to arms.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylprednisolone 80 mg | Local injection of 80 mg Methylprednisolone into the carpal tunnel Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine |
| FG001 | Methylprednisolone 40 mg | 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 |
| FG002 | Placebo | Local injection of saline into the carpal tunnel Saline: 2 mL saline + 1 mL lidocaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylprednisolone 80 mg | Local injection of 80 mg Methylprednisolone into the carpal tunnel Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine |
| BG001 | Methylprednisolone 40 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at follow-up |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | Number of patients who have had carpal tunnel release surgery on the study hand. | Data from all trial participants were available with no withdrawals, drop-outs or missing data. | Posted | Count of Participants | Participants | 5 to 7 years |
|
5 to 7 years
Adverse events from patient-reporting and review of medical records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methylprednisolone 80 mg | Local injection of 80 mg Methylprednisolone into the carpal tunnel Methylprednisolone 80 mg: 2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Isam Atroshi | Hässleholm Hospital, Hässleholm, Sweden | +46443091260 | Isam.Atroshi@skane.se |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone 40 mg | Drug | 1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine |
|
|
| Saline | Other | 2 mL saline + 1 mL lidocaine |
|
|
Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
| 5-7 years |
| Bodily Pain Score | Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). | 5-7 years |
| Satisfaction Score | Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). | 5-7 years |
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
| BG002 | Placebo | Local injection of saline into the carpal tunnel Saline: 2 mL saline + 1 mL lidocaine |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dominant hand treated | Count of Participants | Participants |
|
| Body mass index | BMI at follow-up | Mean | Standard Deviation | kg/m2 |
|
| Follow-up time from randomization/treatment | Mean | Standard Deviation | months |
|
| OG002 | Placebo | Local injection of saline into the carpal tunnel Saline: 2 mL saline + 1 mL lidocaine |
|
|
| Primary | Symptom Severity Score | Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms). | Posted | Mean | Standard Deviation | score on a scale | 5-7 years |
|
|
|
| Secondary | Palmar Pain Score | Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best). | Posted | Mean | Standard Deviation | score on a scale | 5-7 years |
|
|
|
| Secondary | 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst) | Posted | Mean | Standard Deviation | score on a scale | 5-7 years |
|
|
|
| Secondary | Bodily Pain Score | Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best). | Posted | Mean | Standard Deviation | score on a scale | 5-7 years |
|
|
|
| Secondary | Satisfaction Score | Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best). | Posted | Mean | Standard Deviation | score on a scale | 5-7 years |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Methylprednisolone 40 mg | 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 | 0 | 37 | 0 | 37 | 0 | 37 |
| EG002 | Placebo | Local injection of saline into the carpal tunnel Saline: 2 mL saline + 1 mL lidocaine | 0 | 37 | 0 | 37 | 0 | 37 |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |