|Year : 2021 | Volume
| Issue : 1 | Page : 35-39
Efficacy of thumb abduction orthosis versus local methylprednisolone acetate injection in De Quervain's tenosynovitis: A randomized controlled trial
Rakesh Das, Naorem Bimol, Debasish Deb, Shanavas Anoth Meethal, Yumnam Nandabir Singh
Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur, India
|Date of Submission||08-Dec-2020|
|Date of Acceptance||23-Jun-2021|
|Date of Web Publication||04-Aug-2021|
Department of Physical Medicine and Rehabilitation, RIMS, Imphal, Manipur
Source of Support: None, Conflict of Interest: None
Context: De Quervain's disease tenosynovitis is a painful inflammation of tendons on the side of the wrist at the base of the thumb. The most common cause is chronic overuse. It can be self-limited and may resolve without intervention. For those individuals with persistent symptoms, nonsurgical modalities such as rest, massage, cold and heat application, splinting, physical therapy, systemic anti-inflammatory drugs, and corticosteroid injections have been tried with variable success.
Aims: The aim of this study was conducted to compare the efficacy of thumb abduction orthosis with local methylprednisolone acetate injection for the management of De Quervain's tenosynovitis.
Settings and Design: A randomized controlled study was conducted from September 2017 to August 2019, in the Physical Medicine and Rehabilitation Department of a tertiary hospital in Imphal, Manipur.
Subjects and Methods: In Group 1, thumb abduction orthosis was applied, and in Group 2, injection methylprednisolone acetate was given in the first dorsal compartment. Treatment effectiveness was measured by visual analog Scale (VAS) for pain and Quick disabilities score of the Arm, Shoulder, and Hand (quick DASH) for functional assessment. Follow-up assessment was done at 1 month, 3 months, and 6 months.
Statistical Analysis: Chi-square test, independent t-test, and paired t-test were used for analysis.
Results: Out of the total 60 patients, 51 patients were females and 9 were males. There was a significant improvement in both mean VAS scores and Quick DASH scores in both the groups. At 1-month of follow-up, VAS and Quick DASH score in control group significantly improved compared to study group (P < 0.05). However, there was no statistically significant differences between the two groups at 3 months and 6 months follow-up period (P > 0.05).
Conclusions: Although methylprednisolone acetate injection has an excellent outcome, thumb abduction orthosis can be an alternative treatment option for De Quervain's disease.
Keywords: De Quervain's disease, methylprednisolone acetate, thumb abduction orthosis
|How to cite this article:|
Das R, Bimol N, Deb D, Meethal SA, Singh YN. Efficacy of thumb abduction orthosis versus local methylprednisolone acetate injection in De Quervain's tenosynovitis: A randomized controlled trial. J Med Soc 2021;35:35-9
|How to cite this URL:|
Das R, Bimol N, Deb D, Meethal SA, Singh YN. Efficacy of thumb abduction orthosis versus local methylprednisolone acetate injection in De Quervain's tenosynovitis: A randomized controlled trial. J Med Soc [serial online] 2021 [cited 2021 Dec 8];35:35-9. Available from: https://www.jmedsoc.org/text.asp?2021/35/1/35/323157
| Introduction|| |
De Quervain's tenosynovitis is a painful inflammation of tendons on the side of the wrist at the base of the thumb. These tendons include the abductor pollicis longus (APL) and extensor pollicis brevis (EPB). These muscles are located on the dorsal side of the forearm and go to the lateral side of the thumb through a fibrous-osseous tunnel made of the processus styloideus and the extensor retinaculum. This condition is most probably caused by thickening of the extensor retinaculum of the wrist. Although the term “stenozing tenosynovitis” is frequently used, the histopathological examination of De Quervain's disease indicates that it does not involve inflammation but degenerative changes such as myxoid degeneration, fibrocartilaginous metaplasia, and deposition of mucopolysaccharide and neovascularization. This deposition results in thickening of the tendon sheath, painfully entrapping the APL and EPB tendon. The disease typically occurs in females aged 30–50 years. Individuals who perform repetitive activities of the wrist and thumb are most susceptible to de Quervain's disease. Classic patient population is a mother of newborns who are repeatedly lifting a newborn with thumbs radially abducted and wrists going from ulnar to radial deviation. The diagnosis is often clinical, and the signs and symptoms are pain, tenderness at the first dorsal compartment, and a positive Finkelstein's test. The conventional nonsurgical treatments such as rest, massage, cold and heat application, splinting, physical therapy, systemic anti-inflammatory drugs, and corticosteroid injections have been tried with variable success. Surgery is reserved for failure of conservative modalities which involves release of the first dorsal compartment.
It has been hypothesized that this condition which has resulted from overuse and repetitive irritation of the tendon sheath can be relieved by thumb and wrist immobilization using a thumb abductor orthosis. Some patients have a fear of probable side effects of steroid injection, and each of these treatment modalities has its own advantages and disadvantages. Therefore, the main aim of this study is to compare the efficacy of thumb abduction orthosis with methylprednisolone acetate injection in relieving pain and improvement of function in De Quervain's disease.
| Subjects and Methods|| |
A randomized controlled study was conducted in the Physical Medicine and Rehabilitation department of a tertiary teaching hospital in Imphal, Manipur, during September 2017 to August 2019. Patients with De Quervain's disease with the duration of symptoms <6 weeks, aged between 30 and 50 years of age, and willing to comply with the treatment and follow-up assessment were included in the study. Patients with a previous history of acute trauma or wrist fracture, corticosteroid injection during the previous 6 months, local infection, congenital deformity of the hand, pregnancy, rheumatoid arthritis, and diabetes mellitus were excluded from the study.
Sample size was calculated based on the following parameters: mean visual analog scale (VAS) score in the thumb abduction orthosis group of 17.30 (+11.34) and 6.70 (+6.82) in the methylprednisolone group, standard deviation (SD) of 9.08 (reference), significance level of 5% (two sided), and power of 80%.
The final calculated sample size was 30 for each group. After identifying the eligible patients, they were randomized into intervention and control groups after taking informed consent. Block randomization was done, and a block of four was used. Sequence generation was done by the investigator (D. R). Allocation concealment was done using opaque sealed envelopes.
The study tools employed for the study were a pro forma, low-temperature thermoplastic (LTT) thumb abduction orthosis, and injection methylprednisolone.
The LTT thumb orthosis was made in the department by the orthotist. The width of the LTT thumb abduction orthosis covers at least half the circumference of the forearm. The length of the orthosis covers up to two-third of the length of the forearm up to the distal palmar crease and the whole length of the thumb. The orthosis covered the volar aspect of the wrist and the arm.
Four velcro straps over the dorsal aspect of the forearm, wrist, hand, and thumb are used to secure the orthosis. Orthosis was fitted keeping the wrist in neutral position, thumb at 90° abduction, and 15°–20° extension. All the other fingers were able to move freely.
Patients in the intervention group (thumb abduction orthosis) were made to wear the orthosis at least 20 h in a day for 1 month. The orthosis can be removed while bathing, eating, toileting, and activities involving bilateral activity of hand.
The control group was given only one dose of 1 ml (40 mg) methylprednisolone acetate injection at 1 cm proximal from tip of the styloid process of the radius at an angle of 45° to the forearm alongside the other tendons.
Confirmation that the injection has reached the desired compartment was by observation of filling of the tendon sheaths distal to the annular ligament of the first dorsal compartment.
Before the starting of the study, the pain intensity felt by each patient was determined using VAS. In this scale, 0 indicated no pain and 10 indicated the worst pain. Quick disabilities score of the arm, shoulder, and hand (Quick DASH) was also taken for functional assessment.
Follow-up assessments were done at the end of 1 month, 3 months, and 6 months. All the patients were advised to reduce physical activities of the hand. Patients of both the group received analgesic for 7 days. All the participants were informed about the nature of the procedures.
Ethical approval was taken from the Institutional Ethics Committee, RIMS, Imphal.
Statistical analyses were performed by SPSS statistical software version 21.0, Armonk, NY, USA: IBM Corp. Categorical variables were expressed in percentages and compared across the two groups using Chi-square test. Continuous variables were expressed as mean ± SD and compared across the two groups using independent t-test, within the group comparison was done by paired t-test. P < 0.05 was taken as significant.
| Results|| |
A total of 60 patients with De Quervain's disease were included in the study. All the patients completed 6-month follow-up. [Table 1] shows the baseline characteristics of the study participants. There were no statistically significant differences between the two groups.
[Table 2] shows the mean scores of VAS and Quick DASH before and after treatment at different follow-up period. The table shows significant improvement in both mean VAS scores and Quick DASH scores at 1 month, 3 months, and 6 months in both the groups (P < 0.001).
|Table 2: Within group comparison of outcome variables at baseline and at different months of follow-up|
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[Table 3] shows the comparison of mean VAS score and mean Quick DASH score between the two groups at different follow-up periods. It was observed that, after 1 month, the control group significantly improved compared to the intervention group (P < 0.05). However, there were no statistically significant differences between the two groups at 3-month and 6-month follow-up period (P > 0.05).
|Table 3: Between group comparison of outcome variables at baseline and at different months of follow-up|
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During this study, it was observed that all the patients who received methylprednisolone injection complained of pain at the injection site which got relieved during the 1st day. One patient developed stiffness of the first metacarpophalangeal joint after 1 month of orthosis use.
| Discussion|| |
In this study, there was a significant improvement in the mean scores of both the outcome measures, VAS and Quick DASH scores in both the groups at 1-month, 3-month, and 6-month follow-up. However, there were no significant differences with respect to either pain or functional improvement at 3 months and 6 months. However, statistically significant difference was noted at 1-month follow-up. These findings do not corroborate the existing literature as most studies showed statistically significant difference in outcomes between orthosis and corticosteroid group at the end of treatment., However, those studies did not compare the outcome measurement after each follow-up, they compare the outcome measurement only after the last follow-up. During the 1st month, improvement is less in orthosis group which may be due to healing process induced by the immobilization which needs some time.
Previous studies, including some meta-analysis which compared steroid injection with splinting, were in favor of steroid injection. Ashok et al. found that 83.33% of patients had an excellent result with steroid injection compared to only 36.67% in splinting group. Similarly, Weiss et al. found a significant improvement with steroid injection (67%) compared to splinting, where only 19% of patients improved. However, this was a nonrandomized study, which exposed this study to selection and treatment allocation bias. Moreover, in this study, they did not use any functional outcome measure. Richie and Briner et al. carried out a pooled quantitative literature evaluation of conservative treatments of De Quervain's disease, in which they included seven observational studies and found that 83% of patients who received steroid injection alone were free of pain. Furthermore, only 14% of patients who received splinting alone, benefited from the treatment. However, this systemic review has a number of limitations. The selected studies were all observational studies, and no mention of how the studies were selected or how the data were extracted from the selected studies was made.
Ceylan et al. in their retrospective database evaluation found that 61 of 72 patients (84.7%) recovered at 1-month rest with splint and oral and topical anti-inflammatory therapy. The other 11 patients (15.3%) continued to have symptoms despite splinting and medical treatment. In another study, Lane et al. separated their study population into minimal, moderate, and severe illness based on clinical symptoms. They identified a success rate of 88% with nonsteroidal anti-inflammatory drugs and splints in patients with “minimal” symptoms but only a 32% success rate with “moderate to severe” symptoms. These two studies showed that corticosteroid injection is a better option for conservative treatment of De Quervain's disease, but splint can be used as an alternative option. In the present study, we found that both mean VAS and Quick DASH scores are increased at 3-month and 6-month follow-up compared to 1 month, in corticosteroid injection group. This may indicate the recurrence of pain in some patients after 1 month. This finding is consistent with the previous study.
When compared to other controlled studies available so far that assessed effectiveness of splint for De Quervain's tenosynovitis, the following strengths can be noted in this study: strictly following specific inclusion and exclusion criteria, rigorous randomization procedures followed for sequence generation and allocation concealment, clearly defined outcome measures, and the first study using a functional outcome measure to compare between the groups.
There are some limitations in this study. The first limitation was that blinding was not done, and further studies can be conducted where at least the outcome assessor is not aware of the hypothesis. Another limitation of this study was the short follow-up time. The 6-month period may not have been enough to look for any recurrence after treatment. In this study, corticosteroid injection was given blindly. Studies have shown 20%–30% of patients have separate compartment for EPB. Hence, there is a chance of injection failure in blind technique.
| Conclusions|| |
Thumb abduction orthosis improves not only pain intensity but also improves functional status of the patients with De Quervain's disease. Although a higher improvement rate in patient's symptoms is observed in the steroid injection group, the difference between two groups was small in long-term follow-up. Thumb abduction orthosis seems to be a very safe and useful treatment modality particularly in patients who are reluctant to undergo steroid injection or in patients at high risk for side effects of steroid use.
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Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]