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Completed

NCT Number: NCT00806871

Steroid Injection Treatment of Carpal Tunnel Syndrome

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

Hässleholm, 281 25, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone 40 mg

Drug

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 names: Depo-medrol

Methylprednisolone 80 mg

Drug

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

2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine

Other names: Depo-medrol

Sodium Chloride

Drug

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

1 ml 10 mg Lidocaine + 2 ml saline

Other names: Saline, NaCl

Primary outcomes

  1. The CTS symptom severity score after treatment.

    Time frame: 10 weeks

  2. Rate of surgery

    Time frame: 52 weeks

Secondary outcomes

  1. The CTS symptom severity score after treatment

    Time frame: 52 weeks

  2. Time to surgery

    Time frame: 52 weeks

  3. QuickDASH score

    Time frame: 52 weeks

  4. SF-6D score

    Time frame: 52 weeks

  5. Patient satisfaction with the results of treatment (VAS scale)

    Time frame: 52 weeks

  6. Registration of adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2008
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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