Steroid Injection Treatment of Carpal Tunnel Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00806871
First received: December 10, 2008
Last updated: April 3, 2012
Last verified: March 2011
  Purpose

The aim of this study is to assess the efficacy of injecting steroid into the carpal tunnel in relieving symptoms of carpal tunnel syndrome for at least 1 year with outcomes measured with patient evaluated symptoms score.Out of the patients referred by primary care, those with a clinical diagnosis of CTS who have tried wrist splint and whose symptom severity is judged by the examining surgeon to warrant surgery are offered to be put on the waiting list for carpal tunnel release. This means a waiting time of approximately 3 months. Patients who give informed consent will be asked to attend the outpatient clinic for a physical examination followed by allocation to one of the three trial groups. Immediately following the allocation the patients will receive the assigned treatment.


Condition Intervention Phase
Carpal Tunnel Syndrome
Drug: Methylprednisolone 40 mg
Drug: Methylprednisolone 80 mg
Drug: Sodium chloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Local Steroid Injection in the Treatment of Idiopathic Carpal Tunnel Syndrome: A Randomized Double-blind Placebo-controlled Trial Among Patients Planned for Surgical Treatment

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • The CTS symptom severity score after treatment. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Rate of surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The CTS symptom severity score after treatment [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Time to surgery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • QuickDASH score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • SF-6D score [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction with the results of treatment (VAS scale) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Registration of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: November 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: Methylprednisolone 40 mg

Depo-medrol 40 mg , suspension, injection in the carpal tunnel, one time use

1 ml 40 mg Methylprednisolone + 1 ml 10mg Lidocaine + 1 ml saline

Other Name: Depo-medrol
Active Comparator: B Drug: Methylprednisolone 80 mg

Depo-medrol 80 mg , suspension, injection in the carpal tunnel, one time use.

2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine

Other Name: Depo-medrol
Placebo Comparator: C Drug: Sodium chloride

Saline solution 0,9%, injection in the carpal tunnel, one time use

1 ml 10 mg Lidocaine + 2 ml saline

Other Names:
  • Saline
  • NaCl

Detailed Description:

www.biomedcentral.com/1471-2474/11/76

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary, idiopathic CTS
  • Age 18-70 years, either gender
  • Symptom duration of at least 3 months and inadequate response to wrist splint
  • Symptoms of classic or probable CTS according to the diagnostic criteria in Katz hand diagram
  • Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the absence of abnormal nerve conduction study results, 2 surgeons should independently diagnose the patient with CTS.
  • Scheduled for carpal tunnel release (ie, symptom severity indicating need for surgery)exclusion criteria

Exclusion Criteria:

  • Previous steroid injection for CTS in the same wrist
  • Inflammatory joint disease, diabetes mellitus· Vibration-induced neuropathy, polyneuropathy
  • Pregnancy
  • Trauma to the affected hand in the previous year
  • Previous CTS surgery in the affected hand
  • Inability to complete questionnaires due to language problem or cognitive disorder
  • Severe medical illness
  • Known abuse of drugs and/or alcohol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806871

Locations
Sweden
Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK
Hässleholm, Sweden, 281 25
Sponsors and Collaborators
Region Skane
Investigators
Study Chair: Isam Atroshi, MD, PhD Lund university, department of clinical sciences, Hässleholm hospital, department of orthopedics
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT00806871     History of Changes
Other Study ID Numbers: prövningsprotokoll 080723
Study First Received: December 10, 2008
Last Updated: April 3, 2012
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Nerve Compression Syndromes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents

ClinicalTrials.gov processed this record on August 21, 2014