Abstract
The purpose of this study was to test the hypothesis that an improved outcome can be achieved by employing simultaneous steroid injection after percutaneous A1 pulley release. One hundred and twelve digits were randomized to either percutaneous A1 pulley release alone or release of the A1 pulley with a steroid injection. The visual analogue scale score for pain, modified patient global impression of improvement and modified Quinnell grade were assessed at 3 weeks and 3 months after surgery. At 3 weeks, subjective improvement in the group with simultaneous steroid injection was significantly superior. At 3 months, pain score in the patients without a steroid injection was significantly better. No significant differences were found in the modified Quinnell grade. We conclude from this study that the simultaneous steroid injection at the time of surgical release decreases pain and improves subjective outcomes during the early postoperative period after percutaneous trigger finger release.
Introduction
Percutaneous trigger finger release is simple and effective with success rates of 84% to 100% at the mid-term follow-up (Blumberg et al., 2001; Chao et al., 2009; Cihantimur et al., 1998; Gilberts et al., 2001; Ha et al., 2001; Maneerit et al., 2003; Park et al., 2004; Zhao et al., 2014). Even though most patients show satisfactory results after percutaneous release, we have observed some patients who have suffered from swelling, pain and stiffness following release. They have sometimes required postoperative injection of steroids because of prolonged discomfort. Based on our experience, we have assumed that a local steroid injection at the time of release might decrease such an adverse reaction and speed up recovery. Steroid injection with percutaneous trigger finger release has been shown to be beneficial in several studies (Cebesoy et al., 2007; Maneerit et al., 2003).
The purpose of this study was to test the hypothesis that an early recovery of pain and discomfort can be achieved by employing simultaneous steroid injection after percutaneous A1 pulley release. We also evaluated whether the efficacy of an additional steroid injection increases with the severity of preoperative pain and the presence of proximal interphalangeal (PIP) joint contracture.
Methods
Trial design
We conducted a prospective, single-centre, parallel group, randomized controlled trial after obtaining institutional review board approval. The study was submitted in January 2013 to the database (ClinicalTrials.gov) maintained by the U.S. National Library of Medicine at the National Institutes of Health (ID: NCT01781130). Informed consent was obtained and CONSORT (Consolidated Standards of Reporting Trials) guidelines followed. No changes were made to the trial design after commencement.
Sample size
From August 2012 to November 2012, we conducted a pilot study on patients who underwent percutaneous pulley release for trigger finger. In the pilot study, the primary outcome was the change of pain visual analogue scale (VAS) after 3 weeks. The effect size was calculated as a pain VAS change of 2, significance level 5%, and power level 80%. The pain VAS change was determined by 40% change of mean baseline pain (which was 5 points in the pilot study) as minimum meaningful pain reduction. The standard deviation for the change of pain VAS was 2.66. As a result, at least 29 cases were required for each group. If a 20% dropout rate was taken into account, a total of 37 cases were needed for each group. Based on this, we planned to recruit a total of at least 80 cases; we finally recruited 112 patients.
Participants
Patients presenting to our institute with a clinical and/or ultrasonographic study-proven diagnosis of trigger finger, who had been offered a percutaneous trigger finger release, were invited to participate in the study. The inclusion criteria were as follows: (1) male and female outpatients aged 20 to 80 years who had trigger finger persisting for at least 6 months; and (2) had not responded to conservative treatment including rest, stretching exercise, splintage, non-steroidal anti-inflammatory drugs (NSAIDs) and steroid injection. The exclusion criteria were as follows: patients with (1) rheumatoid arthritis; (2) type I diabetes mellitus; (3) infection; (4) a history of more than three steroid injections or any steroid injection in the affected finger within the past month; (5) suspected or confirmed Dupuytren contracture, or pregnancy.
Randomization and group division
Between January 2013 and June 2014, 163 patients diagnosed as having a trigger finger were assessed (see supplementary material 1 and 2, CONSORT flowchart). Fifty-one participants were excluded because of ineligibility criteria. One hundred and twelve patients were enrolled in the study by the first author (MJ). Patients were randomly assigned to two groups: Group 1, percutaneous A1 pulley release alone (release group); and Group 2, percutaneous A1 pulley release with a steroid injection (release and steroid injection group) by drawing slips of paper marked ‘percutaneous release’ or ‘percutaneous release with a steroid injection’ from a sequentially numbered, opaque and completely sealed envelope by an observer not direct part of the study team. The slips were placed in a random order according to a sequence determined by a computer random number generator.
Demographic characteristics of the patients.
Numbers of patients with each grade of modified patient global impression of improvement (PGI-I) postoperatively.
Numbers of patients with each modified Quinnell grade.
Surgical release and steroid injection
Percutaneous A1 pulley release was performed in the outpatient clinic, using a specially designed hook-shaped knife (HAKI knife; BK Meditech Inc., Seoul, Republic of Korea) (Ha et al., 2001). The patient was placed in the supine position and shielded with a sterilized drape so they could not to see the procedure. After preparation of the skin and injection of 1.5–2 mL 2% plain lidocaine, the knife was placed percutaneously over the annulus. A sweeping motion was used to section the A1 pulley proximal and distal to the site. When a grating sensation disappeared, the sectioning of the annulus was complete. The knife was then withdrawn and the patient was asked to flex and extend the digit several times. This technique has been documented in the medical literature (Park et al., 2004).
In the release and steroid injection group, 0.5 mL of 40 mg/mL triamcinolone acetonide (Tamseton; Dongkwang Pham., Pyeongtaek, Republic of Korea) was injected through the operative site with a 26-gauge needle after the release procedure had been completed. The steroid injection was placed on the volar side of the flexor tendon. As the operative wound was small, the amount of injection solution leakage was negligible. The author, a senior hand surgeon (MJP, level 4; Tang and Giddins, 2016), completed all the procedures. NSAIDs were prescribed for 3 days and other postoperative self-directed medication was strictly restricted.
Timing of evaluation
At the outpatient clinic, the outcomes of both treatments were assessed at 3 weeks and 3 months reflecting early and mid-term postoperative period following the procedure. An independent hand surgeon (SJW) who was blinded to group assignments or the procedure performed assessments for all patients.
Outcome measures
We measured the outcome with: (1) a pain scale using a VAS; (2) a modified patient global impression of improvement (PGI-I, Table 2); and (3) modified Quinnell grade (Yalcin and Bump, 2003). The PGI-I was modified by the authors to make the steps of worsening simpler and was used to represent patient satisfaction.
In order to see whether the effect of additional steroids was greater in patients with more severe pain or in those with a PIP joint contracture before release, the patients were separated into subgroups according to the severity of preoperative pain (pain VAS ≥ 6, < 6) and the presence of PIP joint contracture (PIP joint flexion contracture ≥10°, <10°).
Statistical analysis
The pain VAS, modified PGI-I and modified Quinnell grade of the patients in two groups were described using medians and range, and analysed using the Wilcoxon rank sum test between different time-points of evaluation.
Results
Outcomes at 3 weeks after intervention
Comparison of the results obtained at 3-week and 3-month assessments with preoperative data.
Values are presented as median (range).
NS, no statistical differences; VAS, visual analogue scale; PGI-I, patient global impression of improvement.
Outcomes at 3 months after intervention
At 3 months, the release group showed significantly better pain scores, with a mean of 1.3 (release group) and 2.0 (release and steroid injection group) (p = 0.03). The postoperative modified PGI-I grades showed no statistical difference between the results at the 3-month assessments (p = 0.29). The modified Quinnell grades were also improved compared with those before intervention in both groups at 3 months. No significant statistical difference was found between the two groups (p = 0.94) (Table 4).
Additional analysis
In the analysis between the subgroups, at 3 weeks, an increased efficacy of the additional steroid injection was demonstrated in patients with severe pain preoperatively (VAS ≥ 6) compared to those with relatively less pain (VAS < 6). Those patients (n = 26) in the release and steroid injection group who had suffered from severe pain showed significantly better modified PGI-I compared to patients (n = 31) in the release group with severe pain, with a mean of 3.7 (release group) and 4.1 (release and steroid injection group) (p = 0.03). The difference was not significant at the 3-month assessment.
Those patients (n = 23) in the release and steroid injection group who had PIP joint contracture showed superior modified PGI-I to those patients (n = 20) in the release group who had PIP joint contracture at the 3-week assessments, with a mean of 3.7 (release group) and 4.1 (release and steroid injection group) (p = 0.01). At the 3-month assessments there was no significant statistical difference.
Complications
In this study, major complications such as infection, digital nerve injury, tendon rupture, recurrent triggering and bowstringing were not reported in any patients.
Discussion
In the present study, we found that simultaneous steroid injection is effective in decreasing pain and improving subjective outcomes during the early postoperative period after percutaneous trigger finger release. At 3 weeks, modified PGI-I improved more in the release and steroid injection group than in the release group, whereas other measurements showed no difference. The patients had an improved subjective feeling of having been cured with the additional steroid despite identical pain scores or similar modified Quinnell grade. It may be that steroid injection controls inflammation after the procedure.
Several authors have reported the effect of a steroid combined with a trigger finger release. Ryzewicz and Wolf (2006) suggested that painful tenosynovitis without triggering often occurs in patients after a percutaneous release and this may be a result of flexor tendon scoring. They recommended that the use of a corticosteroid along with a local anaesthetic may prevent the post-procedure inflammatory reaction. Maneerit et al. (2003) demonstrated percutaneous trigger thumb release combined with steroid injection has a higher success rate (97%) than that of steroid injection alone (47%). They used steroid injections on the basis of the finding that residual pain from idiopathic tenosynovitis can be alleviated by steroid effect, even though no patients had persistent triggering. Patel and Moradia (1997) suggested that the difference in the success rate of percutaneous release without cortisone (89%) and with cortisone (95%) may be due to idiopathic tenosynovitis that is not related to stenosis. They also mentioned that residual pain was relieved in 70% of cases by an additional cortisone injection. Liu et al. (2016) reported differently that adding steroids did not improve hand function and help them return to work earlier than those in the non-steroid group, although trigger fingers in the steroid group might have shown higher potential to reach a full ROM in 1 week. They included numerous cases (432 digits) but the study was retrospective, whereas our study is a randomized controlled trial of the effectiveness of adding a steroid injection in the treatment for trigger finger with percutaneous release.
After trigger finger release, the local reparative inflammatory reaction is excessive and tends to result in tendon adhesion and scarring in some patients. An additional steroid injection might have a preventive role in this unexpected excessive inflammatory process, while helping to induce a positive outcome. The pharmacological role of a steroid injection wears off with time. Shortly after injection, locally injected corticosteroids alter the action of cytokines involved in inflammation and reduce inflammation and pain in affected joints and tissues (Barnes, 1998; Caldwell, 1996). However, most injectable corticosteroids have a drug half-life of <7 days and their effectiveness is not expected to last for a long time (Dahl and Hammert, 2012). Moreover, the most commonly used corticosteroids are not soluble (Centeno and Moore, 1994; Hochberg et al., 1996). They contain esters that cause them to be highly insoluble in water, which causes aggregation and crystal formation. The crystal deposits that remain in the tendon and the surrounding peritendinous tissue may disrupt smooth gliding, leading to suboptimal function (Benzon et al., 2007; Dahl and Hammert, 2012). These might be possible reasons that the release group, who did not receive an additional steroid injection, experienced growing satisfaction with a statistical improvement in pain at the 3-month assessment. It seems that the beneficial effects of the steroid do not last a long time and there might be a risk of harmful reaction to the tendon or surrounding tissue.
This study demonstrated that the efficacy of an additional steroid tends to be greater in patients with severe preoperative pain and PIP joint contracture. Severe preoperative pain may be due to tenosynovitis, and there may be a persistent fixed flexion deformity of the PIP joint in patients with long-standing pain associated with tenosynovitis. The peritendinous tissue with chronic inflammation, sheath hypertrophy and scarring, and degenerative thickening of the flexor tendons seems to be less responsive to mechanical release. Based on our study, we presumed that pain or contracture can be controlled more quickly by an additional steroid injection after release.
Several adverse effects of steroid injections have been reported including osteomyelitis, cellulitis and ecchymosis, tendon ruptures, atrophy of the fat tissue, local skin atrophy and hypopigmentation in various clinical situations. In particular, increased risk of infection and tendon rupture are major concerns related to our study. We did not observe serious adverse side effects in our trial on trigger finger.
Our study has several limitations. First, we did not investigate the long-term response to treatment, but we think long-term evaluation is not necessary, because most discomfort occurs postoperatively for a relatively short period of time. Second, we could not fully control the steroid injections that each patient had had previously. Even though the steroid injection or injections were performed several months before the procedure, such steroid injections might have an effect on the study’s outcomes. Third, the percutaneous releases were not performed under ultrasound guidance, which has been shown to improve the results. However, because one highly experienced hand surgeon performed all the procedure, a reliable comparison between two groups might be established. A more comprehensive study including co-morbidities, social activities, jobs and sexual difference may be necessary to determine the general validity of the findings of the present study.
We conclude from this study that simultaneous steroid injection at the time of surgical release provides greater subjective improvement in the early period after percutaneous trigger finger release. The steroid injection appears to have a role in controlling the inflammation during the early period after percutaneous release of trigger finger.
Supplemental Material
Supplemental material for Effects of simultaneous steroid injection after percutaneous trigger finger release: a randomized controlled trial
Supplemental Material for Effects of simultaneous steroid injection after percutaneous trigger finger release: a randomized controlled trial by Midum Jegal, Sung Jong Woo, Hyun Il Lee, Jae Woo Shim and Min Jong Park in Journal of Hand Surgery (European Volume)
Footnotes
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Supplementary material
Supplemental material for this article is available online.
References
Supplementary Material
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