AzTrials
AzTrials

Carpal Tunnel SyndromePhase 4NCT02652390

Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

A Phase 4 study testing Methylprednisolone 80 mg, Methylprednisolone 40 mg and Saline in people with Carpal Tunnel Syndrome, run by Region Skane.

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

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… 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 80 mg, Methylprednisolone 40 mg and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
No sites listed yet
Study dates
Feb 2016to Oct 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

About this study

Official title: Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome

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.

Read the detailed description

Extended follow-up protocol:

All 111 trial participants will be contacted by telephone by a researcher and given information about this extended follow-up. A questionnaire together with written information and consent forms will be sent by mail. The questionnaire consists of the CTS symptom severity sale, 11-item DASH scale, bodily pain scale, and a treatment satisfaction visual analog scale (VAS), that were used in previous follow-up evaluations. The questionnaire will also include the 6-item CTS symptoms scale (CTS-6) and the palmar pain scale. The patients will be asked whether and when they had undergone carpal tunnel release surgery on the study hand after they received the injection within the trial. Patients' records will be reviewed to verify data about subsequent surgery on the study hand.

The Chi-square test will be used to compare the 80-mg methylprednisolone group and the placebo group with regard to the proportion of patients who have had carpal tunnel release surgery on the study hand within 5 years after injection (primary outcome). The change in symptom severity score in patients in the 80-mg methylprednisolone group who did not have surgery on the study hand after injection will be compared with the change in symptom severity score in patients who had surgery on the study hand after methylprednisolone injection (co-primary outcome) using analysis of covariance (ANCOVA) adjusting for sex, age, dominance of the study hand and baseline symptom severity score. A similar comparison will be made for the 11-item DASH and the bodily pain scores. The palmar pain score at 5 to 7 years will be compared between the groups using the independent-samples t-test and also ANCOVA to adjust for sex, age and dominance of the study hand. Patients who had surgery after methylprednisolone injection will be compared with patients who had surgery after placebo injection with regard to change from baseline to 5 to 7 years in the symptom severity score, 11-item DASH scale score, bodily pain score and satisfaction score using ANCOVA adjusting for sex, age, dominance of the study hand and respective baseline score. To identify potential predictive factors for long-term benefit after 80 mg methylprednisolone injection, surgery within 5 years will be analyzed according to the variables sex, age, dominance of the study hand, baseline symptom severity score (≥3 versus < 3) and baseline median nerve conduction abnormality (severe/moderate vs mild/normal).

All statistical tests will be 2-sided and a p value of less than 0.05 will indicate statistical significance.

Being tested
Methylprednisolone 80 mg, Methylprednisolone 40 mg, Saline
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 80 mgDrug

    Also called Depo-Medrol

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

  • Methylprednisolone 40 mgDrug

    Also called Depo-Medrol

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

  • SalineOther

    Also called Sodium chloride solution

    2 mL saline + 1 mL lidocaine

Study groups in NCT02652390
Study groupRoleWhat they receive
Methylprednisolone 80 mgExperimentalLocal injection of 80 mg Methylprednisolone into the carpal tunnel
Receives: Drug: Methylprednisolone 80 mg
Methylprednisolone 40 mgExperimentalLocal injection of 40 mg Methylprednisolone into the carpal tunnel
Receives: Drug: Methylprednisolone 40 mg
PlaceboPlacebo comparatorLocal injection of saline into the carpal tunnel
Receives: Other: Saline

What is being measured

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

  1. 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.

    Measured: 5 to 7 years

  2. 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).

    Measured: 5-7 years

Secondary outcomes (4)

  1. Palmar Pain Score

    Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).

    Measured: 5-7 years

  2. 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)

    Measured: 5-7 years

  3. Bodily Pain Score

    Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).

    Measured: 5-7 years

  4. Satisfaction Score

    Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).

    Measured: 5-7 years

Timeline

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

  1. First posted11 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02652390
Sponsor's protocol ID
HLM_CTS_2
Status last verified
Oct 2018
First submitted
8 Jan 2016
Last updated
22 Oct 2018
Data monitoring committee
Yes

Publications

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylprednisolone 80 mg, Methylprednisolone 40 mg and Saline in people with Carpal Tunnel Syndrome, run by Region Skane.

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 5 inclusion and 11 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand (time frame: 5 to 7 years). 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 NCT02652390, which also lists 2 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 22 Oct 2018.

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