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Original Research |

Methylprednisolone Injections for the Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled Trial

Isam Atroshi, MD, PhD; Magnus Flondell, MD; Manfred Hofer, BSc; and Jonas Ranstam, PhD
[+] Article and Author Information

From Hässleholm Hospital, Hässleholm; Kristianstad Hospital, Kristianstad; and Lund University, Lund, Sweden.

Acknowledgment: The authors thank Pia Gunnarsson, study nurse, and Ingela Ranebo, research nurse, at the Department of Orthopedics at Hässleholm and Kristianstad Hospitals for assistance in conducting the trial. They also thank Håkan Lövkvist, PhD, and Professor Jonas Björk at the Medical Statistics and Epidemiology Unit, Skåne Research and Development Center, for their statistical contributions.

Grant Support: By the Region of Scania Research and Development Foundation and Hässleholm Hospital Organization.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-3068.

Reproducible Research Statement: Study protocol: Available from Dr. Atroshi (e-mail, Isam.Atroshi@skane.se). Statistical code: Available from Professor Ranstam (e-mail, jonas.ranstam@med.lu.se). Data set: Request for data can be submitted to Dr. Atroshi (e-mail, Isam.Atroshi@skane.se).

Corresponding Author: Isam Atroshi, MD, PhD, Department of Orthopedics, Hässleholm Hospital, SE 28125 Hässleholm, Sweden; e-mail, Isam.Atroshi@skane.se.

Current Author Addresses: Dr. Atroshi: Department of Orthopedics, Hässleholm Hospital, SE 28125, Hässleholm, Sweden.

Dr. Flondell: Department of Hand Surgery, Skåne University Hospital, SE 20502, Malmö, Sweden.

Mr. Hofer: Department of Physical Therapy, Kristianstad Hospital, SE 29185 Kristianstad, Sweden.

Professor Ranstam: Department of Orthopedics, Lund University, SE 22185, Lund, Sweden.

Author Contributions: Conception and design: I. Atroshi, M. Flondell, M. Hofer.

Analysis and interpretation of the data: I. Atroshi, J. Ranstam.

Drafting of the article: I. Atroshi, M. Flondell.

Critical revision of the article for important intellectual content: I. Atroshi, M. Hofer, J. Ranstam.

Final approval of the article: I. Atroshi, M. Flondell, M. Hofer, J. Ranstam.

Provision of study materials or patients: M. Flondell.

Statistical expertise: J. Ranstam.

Obtaining of funding: I. Atroshi, M. Flondell.

Administrative, technical, or logistic support: I. Atroshi, M. Flondell, M. Hofer.

Collection and assembly of data: I. Atroshi, M. Flondell, M. Hofer.


Ann Intern Med. 2013;159(5):309-317. doi:10.7326/0003-4819-159-5-201309030-00004
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Chinese translation

Background: Steroid injections are used in idiopathic carpal tunnel syndrome (CTS), but evidence of efficacy beyond 1 month is lacking.

Objective: To assess the efficacy of local methylprednisolone injections in CTS.

Design: Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT00806871)

Setting: Regional referral orthopedic department in Sweden.

Patients: Patients aged 18 to 70 years with CTS but no previous steroid injections.

Intervention: Three groups (37 patients each) received 80 mg of methylprednisolone, 40 mg of methylprednisolone, or placebo. The patients and treating surgeons were blinded.

Measurements: Primary end points were the change in CTS symptom severity scores at 10 weeks (range, 1 to 5) and rate of surgery at 1 year. Three patients had missing 10-week data. All patients had 1-year data.

Results: Improvement in CTS symptom severity scores at 10 weeks was greater in patients who received 80 mg of methylprednisolone and 40 mg of methylprednisolone than in those who received placebo (difference in change from baseline, −0.64 [95% CI, −1.06 to −0.21; P = 0.003] and −0.88 [CI, −1.30 to −0.46; P < 0.001], respectively), but there were no significant differences at 1 year. The 1-year rates of surgery were 73%, 81%, and 92% in the 80-mg methylprednisolone, 40-mg methylprednisolone, and placebo groups, respectively. Compared with patients who received placebo, those who received 80 mg of methylprednisolone were less likely to have surgery (odds ratio, 0.24 [CI, 0.06 to 0.95]; P = 0.042). With time to surgery incorporated, both the 80- and 40-mg methylprednisolone groups had lower likelihood of surgery (hazard ratio, 0.46 [CI, 0.27 to 0.77; P = 0.003] and 0.57 [CI, 0.35 to 0.94; P = 0.026], respectively).

Limitation: The study was conducted at 1 center, and wrist splinting had previously failed for all patients.

Conclusion: Methylprednisolone injections for CTS have significant benefits in relieving symptoms at 10 weeks and reducing the rate of surgery 1 year after treatment, but 3 out of 4 patients had surgery within 1 year.

Primary Funding Source: Region of Scania Research and Development Foundation and Hässleholm Hospital Organization.

Figures

Grahic Jump Location
Figure 1.

Study flow diagram.

* All patients had complete baseline and 1-y data for the primary and secondary outcomes; those with missing data at other follow-up times because of early surgery or missing visits (the same patients missed the 10- and 24-wk visits) were included in the statistical model, but the missing data were not replaced.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Kaplan–Meier curves showing the proportion of patients having surgery within 1 year after treatment.

MP = methylprednisolone.

Grahic Jump Location

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Comments

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I read with interest this article
Posted on September 12, 2013
Benjamin Lechner, MD, FACP
Rheumatology, Hallandale Beach, Florida
Conflict of Interest: None Declared
The Kaplan-Meier Curve shown in Figure 2 strikingly corresponds with my experience as a rheumatologist for the past 40 years, treating patients with carpal tunnel syndrome. I find that the methylprednisolone injections last on an average of 12 to 15 weeks at which time a repeat injection is offered. I have many patients who continue with this approach, receiving injections every 12 weeks with excellent results. I always offer them the option of having surgery but many prefer to just come in every 12 weeks and get an injection. I am sure many of my fellow rheumatologists practice the same way. The same cannot be said for the hand surgeons.
Predicting Response to Corticosteroid injections in Carpal Tunnel Syndrome
Posted on September 13, 2013
Francisco Ramirez-Lafita MD, FACP
Rheumatology. Viamed Monegal Hospital. Tarragona, Spain
Conflict of Interest: None Declared
The study by Atroshi et al (1) shows a temporary, but non-persistent relief of CTS symptoms after Methylprednisolone (MP) local injection. In fact, after week 36 there was an increase in the number of patients treated with MP injections that underwent surgery (between 73% and 81% at the end of first year!). Moreover, secondary end points as QuickDASH, SF-36, SF-6D and treatment satisfaction were not longer met after 10 weeks of corticosteroid (CS) injection.
Recent studies have found different outcomes. A recent study (2) comparing local CS injection vs surgical decompression showed that both treatments were effective to alleviate symptoms at 2-years follow-up (60% of CS injected vs 69% of surgically treated showed a 20% improvement in nocturnal paraesthesias).
Another study (3) found better rates for need of surgical decompression in patients previously treated with local injection of CS as compared with Atroshi results. The level of surgical decompression was of 15% at the first year and of 33% at the 5 years. That study concluded that female, diabetes and those patients with neurophysiological confirmation at the time of diagnosis were found to have higher risk of relapse after CS local injection.
A different study (4) disclosed that EMG severity of the CTS constituted an important prognostic factor for long term effect of local CS injection. In fact patients with mild CTS on EMG studies were found to have better responses to CS local injection.
Other authors (5) added ultrasonographic (US) test on CTS work-up. They found that patients with less pronounced median nerve swelling on US test were better responders to CS injection treatment.
Nerve conduction test in the study by Atroshi et al showed that over 80% of patients had severe or moderate results at the baseline. That could explain the poor response to CS injection in the first year in accordance with other studies reviewed.
It could be interesting to investigate degree of nerve involvement before local CS injection in CTS. Nerve conduction or ultrasound test could be good predictors of response to non-surgical treatments.

1. Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone injections for the carpal tunnel syndrome. A Randomized, Placebo-Controlled Trial. Ann Int Med. 2013; 159: 309-317
2. Ly-Pen D, Andréu JL, Millán I, de Blas G, Sánchez-Olaso A. Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial. Rheumatology (Oxford). 2012; 51:1447-1454. doi: 10.1093/rheumatology/kes053. Epub 2012 Mar 30.
3. Jenkins PJ, Duckworth AD, Watts AC, McEachan JE. Corticosteroid injection for carpal tunnel syndrome: a 5-year
survivorship analysis. Hand (N Y). 2012;7:151-156. doi: 10.1007/s11552-012-9390-8.
4. Visser LH, Ngo Q, Groeneweg SJ, Brekelmans G. Long term effect of local corticosteroid injection for carpal tunnel syndrome: a relation with electrodiagnostic severity. Clin Neurophysiol. 2012;123:838-841. doi: 10.1016/j.clinph.2011.08.022. Epub 2011 Oct 1.
5. Meys V, Thissen S, Rozeman S, Beekman R. Prognostic factors in carpal tunnel syndrome treated with a corticosteroid injection. Muscle Nerve. 2011;44:763-8. doi: 10.1002/mus.22183. Epub 2011 Sep 26.
Optimal therapy for carpal tunnel syndrome
Posted on September 27, 2013
Jose Luis Andreu, Domingo Ly-Pen
Hospital Universitario Puerta de Hierro Majadahonda
Conflict of Interest: None Declared
We have read with great interest the article by Atroshi et al (1). This placebo-controlled trial demonstrates that injections in carpal tunnel syndrome (CTS) are a useful and safe therapy, at least in the short-term follow-up, since patients who received corticosteroid injections improved significantly more than those treated with placebo, without relevant adverse effects.
It was somehow surprising for us the high percentage of surgery required in the 1-year follow-up, with figures of 73 % of wrists in the 80-mg methylprednisolone arm versus 92% in the placebo arm. In our study comparing corticosteroid injection versus surgery (2), only 15% of injected wrists needed additional treatment after one year follow-up. Perhaps this discrepancy depends on the corticosteroid preparation used in the two studies (20 mg in 1 ml of paramethasone acetonide in ours) and on the fact that, in our study, protocol permitted the administration of two injections two weeks apart in case of lack of full recovery after the first shot. Although the optimal number, dose and type of corticosteroid injections in the treatment of CTS have not been established, we have the clinical impression that two injections work better than one single injection, without adverse effects. The role of the dose and the potency of the corticosteroid also remains unclear. Even though there is a randomized study in the treatment of CTS (3), where injections with 25 mg hydrocortisone are as effective as higher doses of long acting triamcinolone at a 6-week and 6-month follow-up, longer follow-up periods are not available.
These observations taken together, suggest to us that the relief caused by corticosteroid injections is limited in time. Unfortunately, factors conditioning a more long lasting effect have not been fully elucidated. Another factor that may further complicate comparisons between different trials is the heterogeneous features of enrolled patients. Patients recruited from Primary Care Units are different from those seen in a Surgery or Neurology Clinic. We absolutely agree with Atroshi et al when they state that “future research should explore how to obtain a consistent durable effect. The goal is to find a medical treatment that effectively resolves CTS without the need to divide the transverse carpal ligament”.





REFERENCES:
(1) Atroshi I, Flondell M, Hofer M, Ranstam J. Methylprednisolone Injections for Carpal Tunnel Syndrome. A Randomized, Placebo-Controlled Trial. Ann Intern Med 2013; 159: 309-17.
(2) Ly-Pen D, Andreu JL, Blas G, Sánchez-Olaso A, Millán I. Surgical decompression versus local steroid injection in carpal tunnel syndrome. Arthritis and Rheumatism 2005; 52: 612-9.
(3) O'Gradaigh D, Merry P. Corticosteroid injection for the treatment of carpal tunnel syndrome. Ann Rheum Dis 2000; 59: 918-9.

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Summary for Patients

Steroid Injections for the Carpal Tunnel Syndrome

The full report is titled “Methylprednisolone Injections for the Carpal Tunnel Syndrome. A Randomized, Placebo-Controlled Trial.” It is in the 3 September 2013 issue of Annals of Internal Medicine (volume 159, pages 309-317). The authors are I. Atroshi, M. Flondell, M. Hofer, and J. Ranstam.

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