Steroid Injection Treatment of Carpal Tunnel Syndrome - Full Text View

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:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate Sodium chloride Chlorine

U.S. FDA Resources

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

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:

Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosén I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8.

Atroshi I, Gummesson C, Johnsson R, McCabe SJ, Ornstein E. Severe carpal tunnel syndrome potentially needing surgical treatment in a general population. J Hand Surg Am. 2003 Jul;28(4):639-44.

Wintman BI, Winters SC, Gelberman RH, Katz JN. Carpal tunnel release. Correlations with preoperative symptomatology. Clin Orthop Relat Res. 1996 May;(326):135-45.

Ahlberg J, Johansson H, Widenfalk B. [Disabling injuries following carpal tunnel syndrome surgery] Lakartidningen. 2007 Oct 3-9;104(40):2884-6. Swedish. No abstract available.

Benson LS, Bare AA, Nagle DJ, Harder VS, Williams CS, Visotsky JL. Complications of endoscopic and open carpal tunnel release. Arthroscopy. 2006 Sep;22(9):919-24, 924.e1-2. Review.

Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001554. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Flondell M, Hofer M, Björk J, Atroshi I. Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: protocol of a randomized double-blind placebo-controlled trial (NCT 00806871). BMC Musculoskelet Disord. 2010 Apr 21;11:76.

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
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on May 19, 2013