Long-Term Effectiveness of Bee Venom Acupuncture and Physiotherapy in the Treatment of Adhesive Capsulitis: A One-Year Follow-Up Analysis of a Previous Randomized Controlled Trial

Abstract

Objective:

An earlier randomized controlled trial (RCT) study showed that bee venom acupuncture (BVA) in combination with physiotherapy can be more effective in functional improvement and pain reduction in patients with adhesive capsulitis (AC). The objective of the current study was to examine the long-term effect of BVA in combination with physiotherapy on AC of the shoulder.

Design:

Retrospective 1-year follow-up analysis of a previous RCT using a telephone interview method.

Setting:

Outpatient joint center at the Gang Dong Kyung Hee University Hospital of Seoul, Republic of Korea.

Patients:

A total of 192 patients had been enrolled in the previous study, and 124 of these were excluded from the current study. Sixty-eight patients who had been treated with combined BVA and physiotherapy for AC of the shoulder for 2 months were interviewed at approximately 1 year after treatment by telephone.

Intervention:

Sixty of 68 patients were included in the follow-up analysis. Twenty received BV 1 treatment (1:10,000 concentration BVA plus physiotherapy), 22 received BV 2 treatment (1:30,000 concentration BVA plus physiotherapy), and 18 received control treatment (normal saline injection plus physiotherapy).

Outcome measures:

The primary outcome measure was Shoulder Pain And Disability Index (SPADI) score. Secondary outcome measure was score on verbal rating scale for pain and patient satisfaction.

Results:

Baseline characteristics of the groups did not significantly differ. SPADI scores at 1 year significantly differed between the BV 1 group and the control group (p=0.043). No significant differences were found in pain verbal rating scores after 1 year. Treatment satisfaction with therapy was also assessed, and the BV 1 and BV 2 groups showed significantly greater satisfaction compared with the control group.

Conclusions:

BVA combined with physiotherapy remains clinically effective 1 year after treatment and may help improve long-term quality of life in patients with AC of the shoulder.

Introduction

Adhesive capsulitis (AC) is a chronic disorder that causes long-term limitation of motion and pain.^1,2 It requires long-term treatment and observation. AC is believed to be a condition of uncertain cause that is characterized by substantial restriction of both active and passive shoulder motion and occurs in the absence of a known intrinsic shoulder disorder.³ Some studies have found a prevalence in the general population of 2%–5% and that it is especially prominent in women age 40– and 60 years.^4,5 AC often occurs bilaterally and after onset may also often be contralateral to the originating side.^6,7

The goal of therapy is to reduce pain and improve shoulder function as soon as possible. Treatment regimens for AC include a trial of conservative therapy, followed by more invasive procedures for recalcitrant cases. Physiotherapy (PT) is widely accepted in the conservative management of AC. Injection of corticoids is also commonly used and has been reported to have outcomes similar to those of PT alone. Bee venom acupuncture (BVA), an alternative method for acupuncture, has been long used in Oriental medicine as a traditional medical approach to relieve pain and inflammation.⁸

In a previous randomized controlled trial (RCT) at the authors' institution on the short-term effects of BVA plus PT in patients undergoing AC, shoulder function improved and pain decreased.⁹ However, patients were followed for no longer than 3 months, and thus long-term conclusions could not be made. To address this problem, the current retrospective study was done to assess the long-term effectiveness of BVA plus physiotherapy on AC.

This study presents the 1-year follow-up analysis of the previous randomized controlled trial RCT to evaluate the effectiveness after 2 months' treatment with patient satisfaction assessed to verify whether BVA with PT improved patients' quality of life (QoL) on a long-term basis.

Materials and Methods

Patients

The institutional review board approved the study. The design of the double-blind, randomized clinical trial, together with its short-term outcomes, has been reported previously.⁹ In total, 192 participants were enrolled in the previous study, and 124 were excluded because they did not meet inclusion criteria. Sixty-eight participants who agreed to participate between January 2010 and December 2010 were randomly assigned to receive BV 1 (1:10,000 concentration BVA plus PT), BV 2 (1:30,000 concentration BVA plus PT) or control treatment (normal saline injection plus PT), according to study protocol.

Treatment and study design

Participants in the BV 1 and BV 2 groups were administered intramuscular BV injections with a 1-mL syringe (30 gauge; Hwajin Medical, Seoul, Korea) at a depth of 0.5–1.0 cm. The BV used for the previous study was prepared in the traditional Korean medical pharmacy at Kyung Hee University Hospital. Dried BV powder (Yoomil Garden, Hwasun, Korea) was diluted and prepared as follows: (1) mix 10 mg of dried BV powder in 300 mL (1:30,000) or 100 mL (1:10,000) of saline (JW Pharmaceuticals, Seoul, Korea), and dissolve thoroughly; (2) filter with 0.22-μm filters and fill sterilized vials with 20 mL of the preparation; (3) cap with rubber lid and seal with aluminum capping; (4) store at 4°C. The preparation was concocted in the injection preparation room, and empty vials were first sterilized and then filled because of concerns regarding protein denaturation. Patients in the control group were injected intramuscularly with saline (JW Pharmaceuticals, Seoul, Korea) instead of BV. The target acupuncture points were sterilized with 70% alcohol before injection. Before the first BVA treatment, a skin reaction test was performed on all patients to check for any possible hypersensitivity to BV. An injection of 0.05 mL of 1:30,000 concentration BVA was given subcutaneously at LI 11 with a 1-mL syringe (30 gauge; Hwajin Medical).

A 0.1-mL injection of BVA or control was given at each acupuncture point. Four acupoints were injected with a total volume of 0.4 mL on the first visit, 6 acupoints with 0.6 mL on the second, 8 acupoints with 0.8 mL on the third, and 10 acupoints with a total of 1.0 mL throughout the fourth to 16th visits. All patients were given treatments by the same licensed Korean medical doctor who specializes in acupuncture and moxibustion. The participating Korean medical doctor underwent customized training for a full understanding of treatment protocol, including details such as acupuncture points and dose increments of BVA. The injection volumes were based on the previous study.¹⁰ The acupuncture points selected were LI15 (between the greater tubercle of the humerus and the anterior end of the lateral border of the acromion), LI16 (between the spine of the scapula and the acromial end of the clavicle), TE14 (between the greater tubercle of the humerus and the acromial angle), GB21 (midpoint of the line connecting the lateral end of the acromion with the spinous process of the seventh cervical vertebra (C7)), SI11 (between the upper third and lower two thirds of the line connecting the midpoint of the spine of the scapula with the inferior angle of the scapula), and 5 additional points around the shoulder.¹¹

All participants in the three groups were given PT, which was performed at each visit by a single physical therapist with over 7 years of clinical experience. Fifteen minutes of transcutaneous electrical nerve stimulation (TENS 21, Homer Ion Laboratory Co., Ltd., Tokyo, Japan)^12,13 and 15 minutes of transcutaneous infrared thermotherapy (TDP 100, ITC Co., Ltd., Daejeon, Korean) were administered 2 times a week, and manual physical therapy was given for 15 minutes once a week. Participants were told to perform home exercise twice daily until completion of all 16 sessions, with a researcher checking their progress at each visit. The simple home exercise program was based on previous studies.^14
–16 It consisted of 5 activities, and the participants were instructed to perform the exercises for 1 to 2 hours daily.

One-year follow-up analysis was conducted between March 2011 and September 2011 to evaluate effectiveness after the 2 months of treatment and patients' satisfaction with treatment. The authors contacted patients who had been treated with a combination of BVA and PT for 2 months at approximately 1 year after treatment by telephone.

Inclusion criteria were as follows: patients who received 16 separate sessions of a combination of BVA and PT for 2 months, who were previously diagnosed as having AC by orthopedic doctors, and patients older than age 18 and younger than age 70 years. Exclusion criteria were as follows: patients with other disorders that could account for presenting shoulder symptoms, diagnosed clinically or by testing; patients with cervical neuropathy, neurologic changes, or paralysis of the affected upper limb; history of shoulder injury or surgery; patients with hypersensitive reactions after BV skin testing, hepatic or renal disorders, diabetes with complications, hematopoietic diseases, allergies, cerebrovascular disorders, fractures, open wound at bee venom administration site, mental disorders that could affect diagnosis or progress of the disorder, malignancy, or degenerative, infectious, or inflammatory arthritis; pregnant or breastfeeding women; persons unavailable for telephone interview; and those who had received other treatments, including acupuncture, medication, or injection.

Outcome measures

The Shoulder Pain and Disability Index (SPADI) was used to assess QoL, and pain was evaluated for three states: at rest, at night, and during motion. To assess pain, a verbal rating scale (VRS) was used in this study, in which 0 represented “painless” and 10, “most extreme pain imaginable.”

Participants were asked about treatment satisfaction and whether they would recommend the same treatment to others. Treatment satisfaction was scored on a scale of 1 to 5, with 1 indicating “very unsatisfactory” and 5, “very satisfactory.” Patient recommendation of therapy was graded on a scale of 1 to 5, with 1 being “completely inadvisable” to 5 being “completely advisable.”

Participants were asked whether they had received other treatments after the previous study ended, had recurrences, and had exercised continuously. If a participant did have additional treatments, the assessors recorded whether the treatment was PT for improving range of motion (ROM) from a professional physical therapist for over 1 month; acupuncture performed by a licensed Korean medicine doctor; or conventional medicine–based injections, medication, or surgery. Recurrences in the ipsilateral shoulder were recorded, along with symptoms of pain or loss of ROM in the contralateral shoulder. A participant was considered to have exercised continuously if he or she exercised for more than 2 times weekly over 6 months, and if the exercise program included stretching, muscle strengthening, and motions for improving ROM.

Baseline characteristics, including age, sex, lesion type, disorder duration, SPADI score, and pain VRS score (at rest, at night, and during motion) after 2 months of treatment were compared between groups.

Statistical analysis

Data were analyzed by using SPSS software for Windows, version 16.0 (SPSS, Inc., Chicago, IL). Homogeneity testing between groups was performed by one-way analysis of variance and a chi-squared test. Independence testing was performed by one-way analysis of variance, and post hoc analysis was done by using Bonferroni correction. A p-value of <0.05 was considered to represent a statistically significant difference.

Results

Sixty of 68 participants included in the randomized clinical trial were included in the follow-up analysis. Of the 8 participants excluded from the analysis, 5 did not finish the clinical study, 2 had other treatment after completion of 2 months BVA with PT treatment, and 1 could not be contacted.

In this study, 60 patients were divided into 3 groups: BV 1 (n=20, 1:10,000 concentration BVA plus PT), BV 2 (n=22, 1:30,000 concentration BVA plus PT), and control (n=18, normal saline injection plus PT). Intergroup homogeneity of sex, age, disorder duration, and lesion type was tested beforehand with a chi-squared test on the final 60 participants, and results showed no significant difference between groups in any sociologic or population-related factors. Baseline values for SPADI and pain VRS did not differ for at rest, at night, and during motion between groups (Table 1).

Table 1.

Baseline Characteristics of 60 Patients with Adhesive Capsulitis

	Patients, n (%)
Characteristic	BV 1 group (n=20)	BV 2 group (n=22)	Control group (n=18)	Overall	p-Value
Age (y)	55.4±6.8	52.8±7.3	56.4±7.9	54.8±7.4	0.547
Sex
Male	6 (30)	8 (36.4)	4 (22.2)	18 (30)	0.783
Female	14 (70)	14 (73.6)	14 (78.8)	42 (70)
Lesion type
Right	9 (45)	7 (31.8)	7 (38.9)	23 (38.3)	0.909
Left	11 (55)	15 (68.2)	11 (61.1)	37 (61.7)
Duration (mo)	6.8	5.9	6.7	6.4
SPADI score	22.15±12.25	26.21±16.67	31.52±15.21	26.45±15.09	0.162
Pain VRS score at rest	2.48±1.45	3.07±1.92	3.53±1.56	3.00±1.69	0.157
Pain VRS score at night	2.50±1.73	2.66±1.55	3.14±1.86	2.75±1.70	0.496
Pain VRS score during motion	2.85±1.50	3.16±1.64	3.64±1.76	3.20±1.64	0.335

Control group received normal saline injection+physiotherapy. Unless otherwise noted, values are the mean±standard deviation.

BV 1, bee venom injection 1:10,000+physiotherapy; BV 2, bee venom injection 1:30,000+physiotherapy; SPADI, Shoulder Pain and Disability Index; VRS, verbal rating scale.

SPADI scores for the BV 1, BV 2, and control groups 1 year after completion of treatment in the previous study were compared, and a statistically significant difference was found between BV 1 and control (p=0.043). The difference between average SPADI scores at baseline and at the 1-year timepoint was almost identical (Table 2). This indicates that BVA with PT remains effective for over 1 year.

Table 2.

Shoulder Pain and Disability Index and Pain Verbal Rating Scale Outcomes After One Year

Variable	Group	Baseline	After 1 y	Mean difference (95% confidence interval)	p-Value
SPADI score	BV 1	22.15±12.25	4.35±5.58	17.81 (12.19–23.43)	0.043^*
	BV 2	26.21±16.67	6.87±9.05	19.34 (12.34–26.33)
	Control	31.52±15.21	13.57±17.16	17.95 (9.53–26.37)
Pain VRS score at rest	BV 1	2.48±1.45	0.63±1.04	1.85 (1.21–2.49)	0.108
	BV 2	3.07±1.92	0.71±1.17	2.36 (1.54–3.19)
	Control	3.53±1.56	1.61±2.30	1.92 (0.72–3.11)
Pain VRS score at night	BV 1	2.50±1.73	0.53±1.07	1.97 (1.33–2.62)	0.096
	BV 2	2.66±1.55	0.71±1.13	1.95 (1.22–2.68)
	Control	3.14±1.86	1.61±2.42	1.53 (0.26–2.79)
Pain VRS score during motion	BV 1	2.85±1.50	0.88±1.37	1.97 (1.11–2.84)	0.171
	BV 2	3.16±1.64	1.02±1.39	2.14 (1.40–2.87)
	Control	3.64±1.76	1.89±2.43	1.75 (0.38–3.12)

Control group received normal saline injection+physiotherapy. Unless otherwise noted, values are the mean±standard deviation.

p<0.05.

No statistically significant difference in pain VRS scores was found among the 3 groups 1 year after completion of treatment. The difference between average pain VRS scores at baseline and at the 1-year timepoint was almost identical (Table 2). However, pain VRS for “pain at night” tended toward a meaningful difference between groups (p=0.096), and pain VRS scores at rest, at night, and during exercise showed differences larger than 1 point between the BV 1 and the control groups. This may suggest that BVA with PT remains clinically effective for over 1 year.

Groups with BVA with PT showed a generally higher level of satisfaction and tended to recommend the treatment more than did the control and PT group, and this was especially evident in BV 1 (Table 3). This study showed that 11, 14, and 13 participants from the BV 1, BV 2, and control groups, respectively, continued to exercise after the initial study (Table 4). The similar numbers suggest that continued exercise was not likely to have affected the results of the present study. Patients who received additional treatment were excluded from the study to minimize any bias that may occur from them. Recurrences were seen in 1, 3, and 4 patients from the BV 1, BV 2, and control groups, respectively, showing that groups with BV treatment had less recurrence, although the disparity was small.

Table 3.

Scores of Treatment Satisfaction and Recommendation After One Year

	Score
Group	5	4	3	2	1	Mean score
Treatment satisfaction
BV 1	7	12	1	0	0	4.30 ± 0.57
BV 2	8	11	3	0	0	4.23 ± 0.69
NS	2	11	5	0	0	3.83 ± 0.62
Treatment recommendation
BV 1	14	5	1	0	0	4.60 ± 0.75
BV 2	10	6	4	2	0	4.09 ± 1.02
NS	5	7	6	0	0	3.94 ± 0.80

Control group received normal saline injection + physiotherapy. Unless otherwise noted, values are the mean ± standard deviation.

Score, scale of 1 to 5, with 1 indicating “very unsatisfactory” or “completely inadvisable” and 5, “very satisfactory” or “completely advisable.”

Table 4.

Continuous Exercise and Other Treatments in Study Patients

Variable	Group	Patients (n)	Details
Continuous exercise	BV 1	11	Continuous exercise: more than 6 months and twice per week, including motions for ROM improvement, muscle strengthening, stretching
	BV 2	14
	Control	13
Other treatments	BV 1	1	Acupuncture treatment
	BV 2	0
	Control	1	Injection and medication
Recurrence of symptoms	BV 1	1	Ipsilateral shoulder pain (1 person)
	BV 2	3	Ipsilateral shoulder pain (1 person)Contralateral shoulder pain (2 people)
	Control	4	Ipsilateral shoulder pain (3 people)Contralateral shoulder pain and limitation of ROM (1 person)

Control group received normal saline injection+physiotherapy.

ROM, range of motion.

Discussion

AC is a common disease characterized by pain and progressive loss of active and passive motion in the shoulder, although its mechanism is not yet known. Causes of AC are diverse, and the main underlying pathology is still unknown.¹⁷ It will often persist for years and may never fully resolve. A study showed that 40% of patients with AC experienced pain and stiffness for over 3 years,¹⁸ and 15% of patients had long-term disabilities and low QoL.¹⁹

The diagnosis is mainly performed clinically, and imaging is using to rule out other diseases. Generally, the differential diagnosis includes neoplasm, acromioclavicular arthropathy, glenohumeral osteoarthritis, autoimmune disease, rotator cuff tendinopathy or tear (with or without impingement), biceps tendinopathy, and subacromial/subdeltoid bursitis.²⁰

Various treatment options exist, but most are not supported by high-level evidence. Nonsurgical treatments include oral prednisone, intra-articular corticosteroid injections, nonsteroidal anti-inflammatory drugs, and physical therapy. Surgical treatments include manipulation of the joint under anesthesia and capsular release techniques.²⁰

Traditional Korean medicine practitioners currently treat adhesive capsulitis with a combination of PT, acupuncture, and BVA. The latter has anti-inflammatory and analgesic effects,^21,22 and PT has been shown to have beneficial effects on adhesive capsulitis.^14,15 In a previous randomized controlled trial, the current authors found that the combination of these two independently effective treatments had improved efficacy on pain and QoL in patients with AC.⁹ A combination of corticosteroid injection and PT showed better improvement of SPADI scores and ROM compared with normal saline injection and greater ROM recovery compared with PT or oral corticosteroid treatment alone.²³ However, the currently popular combination of BVA and PT has little supporting evidence, and follow-up studies conducted over 1 year are unavailable.

The authors have evaluated whether the combination of BVA and PT remained more effective than conventional physical therapy alone 1 year after treatment and aimed to provide evidence on the long-term effectiveness of this treatment combination in the clinic among patients with AC.

The 60 patients included in the present study had a mean age of 54.8 years, similar to other studies on the subject. There were more women in the follow-up study (28 [30%] men and 42 [70%] women). This differs from most other studies, which showed an even distribution between male and female, although Nam and colleagues also had more female participants in their study.²⁴ The mean period from onset to the start of treatment was 6.4 months. Right and left shoulders were affected in 23 (38.3%) and 37 (61.7%) patients, respectively.

SPADI scores of the BV 1, BV 2, and control groups 1 year after treatment showed statistically significant differences between the BV 1 group and control group (p=0.043). The disparity in mean SPADI scores between groups was almost identical at baseline and at 1 year (Table 2). This could be interpreted as indicating that the combination of BVA and PT remained effective 1 year after treatment.

No statistically significant difference was seen in pain VRS scores after 1 year. The disparity in mean pain VRS scores between groups was almost identical at baseline and at 1 year (Table 2). Mean nocturnal pain VRS scores did not show a statistically significant tendency (p=0.096), and mean VRS scores for pain at rest, at night, and during exercise showed a difference greater than 1 between the BV 1 group and control group 1 year after treatment. These latter points may be interpreted as suggesting that this combination of treatment remained effective after 1 year. Groups subjected to both BVA and PT showed better treatment satisfaction and patient recommendation of therapy compared with the normal saline injections and PT, especially in the BV 1 group (Table 3). This study showed that 11, 14, and 13 patients from the BV 1, BV 2, and control groups, respectively, continued to exercise. The similar numbers in all groups indicate that exercise continuity is unlikely to have affected the outcome of the present study. Participants who had additional treatment after the last study were excluded from the present study to minimize any possible bias. Recurrence was evaluated in both shoulders for pain and limitation of motion, but no patient showed recurrence at any site (Table 4).

Carette and colleagues found no differences in patients treated with both PT and corticosteroids, either PT or corticosteroids, or normal saline after 12 months.²³ Further, Blanchard and associates also showed no long-term effect in patients who injected corticosteroids.²⁵ However, the present study showed a statistically significant difference in SPADI scores between groups at 1 year between the BV 1 and control groups, and the difference in average SPADI scores also remained largely unchanged.

Conclusions

This study indicates that BVA with PT remains clinically effective until 1 year after treatment and may help improve long-term QoL. However, the present study was retrospective and had a small number of participants, and therefore the conclusions cannot be generalized. Additional large-scale randomized studies of AC with long-term follow-up based on the present study may reveal a more accurate picture of this field.

Footnotes

Acknowledgments

We would like to acknowledge the Joint and Rheumatology Center of Kyung Hee University Hospital at Gang-dong. The study was fully supported by a grant from Kyung Hee University in Korea.

Author Disclosure Statement

No competing financial interests exist.

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