A Phase 4 interventional study of Methylprednisolone 80 mg and Methylprednisolone 40 mg in Carpal Tunnel Syndrome, sponsored by Region Skane. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-22.
Sponsored by Region Skane · Phase 4, Interventional, and Treatment
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.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's enrollment of 111 is above the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Region Skane is the lead sponsor of 382 studies on the registry; 118 are open to participants now.
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Exclusion Criteria:
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 80 mg
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 40 mg
Local injection of saline into the carpal tunnel
Other: Saline
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
Also known as: Depo-Medrol
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
Also known as: Depo-Medrol
2 mL saline + 1 mL lidocaine
Also known as: Sodium chloride solution
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.
Time frame: 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).
Time frame: 5-7 years
Palmar Pain Score
Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
Time frame: 5-7 years
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)
Time frame: 5-7 years
Bodily Pain Score
Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
Time frame: 5-7 years
Satisfaction Score
Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
Time frame: 5-7 years
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.
| Milestone | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| Started | 37 | 37 | 37 |
| Completed | 37 | 37 | 37 |
| Not completed | 0 | 0 | 0 |
Number of patients who have had carpal tunnel release surgery on the study hand.
| Participants | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand | 31 | 34 | 36 |
Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).
| score on a scale | 80-mg Mrthylprednisolone and no Surgery | Surgery After Methylprednisolone or Placebo |
|---|---|---|
| Symptom Severity Score | 1.34 ± 0.9 | 1.53 ± 0.9 |
Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
| score on a scale | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| Palmar Pain Score | 86.4 ± 18 | 84.6 ± 22 | 83.0 ± 25 |
Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
| score on a scale | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score | 13.1 ± 18 | 16.9 ± 20 | 19.3 ± 20 |
Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
| score on a scale | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| Bodily Pain Score | 81.4 ± 24 | 79.9 ± 24 | 78.2 ± 25 |
Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
| score on a scale | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo |
|---|---|---|---|
| Satisfaction Score | 77.5 ± 28 | 71.4 ± 27 | 68.4 ± 28 |
Collected over 5 to 7 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methylprednisolone 80 mg | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Methylprednisolone 40 mg | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Placebo | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Age, Continuous(years) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 53 ± 12 | 50 ± 11 | 55 ± 12 | 53 ± 12 |
| Sex: Female, Male(Participants) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 26 | 27 | 28 | 81 |
| Male | 11 | 10 | 9 | 30 |
| Race (NIH/OMB)(Participants) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 37 | 37 | 37 | 111 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Sweden | 37 | 37 | 37 | 111 |
| Dominant hand treated(Participants) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Count of participants | 30 | 29 | 28 | 87 |
| Body mass index(kg/m2) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 27.3 ± 4.2 | 27.6 ± 4.3 | 27.7 ± 5.7 | 27.5 ± 4.8 |
| Follow-up time from randomization/treatment(months) | Methylprednisolone 80 mg | Methylprednisolone 40 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 74 ± 7.5 | 74 ± 7.1 | 74 ± 7.1 | 74 ± 7.2 |
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Studies of the drug tested here: Methylprednisolone