AzTrials
AzTrials

Carpal Tunnel SyndromePhase 2/3NCT00806871

Steroid Injection Treatment of Carpal Tunnel Syndrome

A Phase 2/3 study testing Methylprednisolone 40 mg, Methylprednisolone 80 mg and Sodium chloride in people with Carpal Tunnel Syndrome, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Methylprednisolone 40 mg, Methylprednisolone 80 mg and Sodium chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteSweden
Study dates
Nov 2008to Apr 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Ortopediska kliniken, sjukvårdsorganisationen Hässleholm/CSK

    Hässleholm, 281 25

Other trials in Sweden

About this study

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

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.

Read the detailed description

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

Being tested
Methylprednisolone 40 mg, Methylprednisolone 80 mg, Sodium chloride
Medical subject headings
Carpal Tunnel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Methylprednisolone 40 mgDrug

    Also called Depo-medrol

    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

  • Methylprednisolone 80 mgDrug

    Also called Depo-medrol

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

    2 ml 80mg Methylprednisolone + 1 ml 10mg Lidocaine

  • Sodium chlorideDrug

    Also called Saline, NaCl

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

    1 ml 10 mg Lidocaine + 2 ml saline

Study groups in NCT00806871
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: Methylprednisolone 40 mg
BActive comparatorNot described
Receives: Drug: Methylprednisolone 80 mg
CPlacebo comparatorNot described
Receives: Drug: Sodium chloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The CTS symptom severity score after treatment.

    Measured: 10 weeks

  2. Rate of surgery

    Measured: 52 weeks

Secondary outcomes (6)

  1. The CTS symptom severity score after treatment

    Measured: 52 weeks

  2. Time to surgery

    Measured: 52 weeks

  3. QuickDASH score

    Measured: 52 weeks

  4. SF-6D score

    Measured: 52 weeks

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

    Measured: 52 weeks

  6. Registration of adverse events

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00806871
Sponsor's protocol ID
prövningsprotokoll 080723
Status last verified
Mar 2011
First submitted
10 Dec 2008
Last updated
4 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.

    PubMed 10411196

  • 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. doi: 10.1016/s0363-5023(03)00148-5.

    PubMed 12877853

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

    PubMed 8620634

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

    PubMed 17966804

  • 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. doi: 10.1016/j.arthro.2006.05.008.

    PubMed 16952718

  • Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD001554. doi: 10.1002/14651858.CD001554.pub2.

    PubMed 17443508

  • 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.

    PubMed 34677593

  • 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.

    PubMed 24026316

  • Flondell M, Hofer M, Bjork 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. doi: 10.1186/1471-2474-11-76.

    PubMed 20409331

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Methylprednisolone 40 mg, Methylprednisolone 80 mg and Sodium chloride in people with Carpal Tunnel Syndrome, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The CTS symptom severity score after treatment. (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00806871, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in