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
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome||Drug: Methylprednisolone 80 mg Drug: Methylprednisolone 40 mg Other: Saline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Methylprednisolone 80 mg
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 80 mg
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
Other Name: Depo-Medrol
Experimental: Methylprednisolone 40 mg
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 40 mg
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
Other Name: Depo-Medrol
Placebo Comparator: Placebo
Local injection of saline into the carpal tunnel
2 mL saline + 1 mL lidocaine
Other Name: Sodium chloride solution
- Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand [ Time Frame: 5 to 7 years ]Number of patients who have had carpal tunnel release surgery on the study hand.
- Symptom Severity Score [ Time Frame: 5-7 years ]Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).
- Palmar Pain Score [ Time Frame: 5-7 years ]Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).
- 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 5-7 years ]Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)
- Bodily Pain Score [ Time Frame: 5-7 years ]Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
- Satisfaction Score [ Time Frame: 5-7 years ]Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).