- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02652390
Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome
Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary idiopathic CTS
- Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)
- Failed treatment with wrist splinting (2 months)
- Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis
- Symptom severity that warranted referral for consideration for surgery
Exclusion Criteria:
- Previous steroid injection for CTS
- Thenar muscle atrophy
- Sensory deficit (two-point discrimination >8 mm)
- Diabetes, thyroid disorder, or inflammatory disease
- Polyneuropathy or vibration-induced neuropathy
- Current pregnancy
- Previous carpal tunnel surgery on the study hand
- Surgery on the contralateral hand in the past 2 months
- Inability to respond to questionnaires
- Severe medical illness
- Known drug/alcohol abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Methylprednisolone 80 mg
Local injection of 80 mg Methylprednisolone into the carpal tunnel
|
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
Other Names:
|
Experimental: Methylprednisolone 40 mg
Local injection of 40 mg Methylprednisolone into the carpal tunnel
|
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
Other Names:
|
Placebo Comparator: Placebo
Local injection of saline into the carpal tunnel
|
2 mL saline + 1 mL lidocaine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 to 7 years
|
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).
|
5-7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
5-7 years
|
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)
|
5-7 years
|
Bodily Pain Score
Time Frame: 5-7 years
|
Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).
|
5-7 years
|
Satisfaction Score
Time Frame: 5-7 years
|
Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).
|
5-7 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Wounds and Injuries
- Disease
- Neuromuscular Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Median Neuropathy
- Nerve Compression Syndromes
- Cumulative Trauma Disorders
- Sprains and Strains
- Syndrome
- Carpal Tunnel Syndrome
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- HLM_CTS_2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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