Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

NCT02652390 | Completed Phase 4 Results DMC

• 1 other identifier: HLM_CTS_2
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand

  Number of patients who have had carpal tunnel release surgery on the study hand.

  5 to 7 years

• Symptom Severity Score

  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 Outcomes (4)

• Palmar Pain Score

  5-7 years

• 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

  5-7 years

• Bodily Pain Score

  5-7 years

• Satisfaction Score

  5-7 years

Study Arms (3)

Methylprednisolone 80 mg

EXPERIMENTAL

Local injection of 80 mg Methylprednisolone into the carpal tunnel

Drug: Methylprednisolone 80 mg

Methylprednisolone 40 mg

EXPERIMENTAL

Local injection of 40 mg Methylprednisolone into the carpal tunnel

Drug: Methylprednisolone 40 mg

Placebo

PLACEBO COMPARATOR

Local injection of saline into the carpal tunnel

Other: Saline

Interventions

Methylprednisolone 80 mg DRUG

2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine

Also known as: Depo-Medrol

Methylprednisolone 80 mg

Methylprednisolone 40 mg DRUG

1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine

Also known as: Depo-Medrol

Methylprednisolone 40 mg

Saline OTHER

2 mL saline + 1 mL lidocaine

Also known as: Sodium chloride solution

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Related Publications (2)

• 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.

  PMID: 24026316 RESULT

• 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.

  PMID: 34677593 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Methylprednisolone; Methylprednisolone Acetate; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Isam Atroshi
• Organization: Hässleholm Hospital, Hässleholm, Sweden

Isam.Atroshi@skane.se

+46443091260

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 11, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 22, 2018
• Results First Posted: October 22, 2018

Record last verified: 2018-10