Acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders 11. A l-year follow-up study Thomas List and Martti Helkimo Department of Stomatognathic Physiology, The Institute for Postgraduate Dental Education, Jonkoping, Sweden

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List T, Helkimo M. Acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders. 11. A l-year follow-up study. Acta Odontol Scand 1992;50:375-385. Oslo. ISSN 0001-6357. Eighty patients, of whom 22 were men and 58 women, participated in a l-year follow-up study. AH participants in the study showed signs and symptoms of craniomandibular disorders (CMD) and had had pain for more than 6 months at treatment start. The patients were randomly assigned to either acupuncture or occlusal splint therapy. Those patients who did not respond to either of the treatment modes were offered various additional therapies. The result showed that 57% of the patients who received acupuncture and 68% of the patients treated with occlusal splint therapy benefited subjectively (p < 0.01) and clinically ( p < 0.001) from the treatment over a 12-month period. No statistically significant difference was found between the two groups as to the assessment variables. Those patients who received various additional therapies after acupuncture and/or occlusal splint therapy responded favorably to additional treatment in only a few instances. The study showed that acupuncture gave positive results similar to those of occlusal splint therapy in patients with primarily myogenic CMD symptoms over a 1-year follow-up period. 0 Acupuncture therapy; controlled clinical trial; occlusaf spints; temporomandibular joint syndrome Thomas List, Department of Prosthodontics and Stomatognathic Physiology, S-58185 Linkoping, Sweden

Craniomandibular disorders (CMD) are generally accepted as being of multifactorial origin (1-5). Several studies have shown that conservative stomatognathic treatment (for example, counseling, occlusal splints, occlusal adjustments, jaw exercises) is effective in reducing the severity of signs and symptoms of CMD (6-8). For most patients, favorable long-term effects of the treatments have been reported (7,s). Another method of reducing pain, which has been used since ancient times, is acupuncture (9,lO). In several experimental clinical studies, an increase in the pain threshold during acupuncture stimulation (11,12) and a decrease in pain sensitivity sufficient to allow major surgical events (13) have been reported. The analgesic action is probably multifactorial, comprising segmental mechanisms at the entry region in the central nervous system (14), supraspinal descending effects, including the release of endogenous opioids and other neuromodu-

latory substances (15,16), and psychologic mechanisms (17). The long-lasting pain relief reported after acupuncture treatment is still difficult to understand. It has been assumed that the inhibitory mechanisms are potentiated, possibly due to activation of gene-related systems (18,19). Although long-term effects of several types of somatic pain have been reported (20), no longitudinal studies on CMD patients have been presented. The aims of this study were to 1) evaluate the long-term effects of acupuncture and occlusal splint therapy over a period of 1 year in patients showing good short-term effects of the therapies; 2) analyze whether it is possible to predict from anamnestic, subjective, and clinical variables which patients are responders and non-responders to acupuncture treatment and occlusal splint therapy; and 3) determine whether various additional therapies could be beneficial to patients who did not respond favorably to

376 T. List

& M. Helkimo

either acupuncture or occlusal splint therapy.

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Materials and methods Subjects Eighty patients, 58 women and 22 men, participated in the study. Their median ages were 44 and 37 years, respectively, ranging from 19 to 71 years. All the patients had been referred to the Department of Stomatognathic Physiology at the Institute for Postgraduate Dental Education in Jonk6ping, Sweden, for treatment of CMD. All patients were examined clinically with regard to pain and dysfunction of the masticatory system, and a comprehensive history was taken before they were accepted for the study, to obtain a homogeneous group. Inclusion criteria were signs and symptoms of CMD of primarily muscular ongin, pain for more than 6 months, and a clinical dysfunction index of DiII or more in accordance with Helkimo (21). The patients involved in this study are identical with the patients receiving acupuncture or occlusal splint therapy described in detail in part I of this study (22). All patients participating in the study gave their informed consent and were informed about the project. The ethical principles in the Declaration of Helsinki were followed in the study. Procedure The investigation was carried out by two operators: one (M. Helkimo) performed the screening and the evaluation, and the other (T. List) the patient treatment. The patients were subsequently randomly assigned to one of three groups: acupuncture (group A), occlusal splint therapy (group B), and a control group (group C) with no active treatment. Only the patients in groups A and B are analyzed in this study. To obtain a mean value of the intensity and frequency of pain, a base line of 1 month preceded the active treatment. The treatment period lasted between 6 and 8 weeks for both groups. All the patients in the acupuncture group received from six to eight treatments. In a

ACTA ODONTOL SCAND 50 (lW2)

few cases of late treatment response--that is, patients showing a tendency to improve at the last evaluation-we chose to extend the treatment period 1-2 weeks before the decision was made as to whether to change the treatment method. The treatment procedure has been described in detail previously (22). The regional acupuncture points that were stimulated manually (Ex 2, St 7, St 6, Gb 20) were standardized as much as possible, even though they differed slightly from individual to individual owing to localization of the pain and points tender to palpation. Two non-regional points, one in the hand (Li4) and the other in the leg (St 36), were stimulated with low-frequency (2-Hz) current. The acupuncturz treatments lasted for 30 min each and were given at 1week intervals. In the other group the patients received an occlusal splint in the upper jaw, constructed with a stable occlusion and canine guidance (22). Only in patients with molar loss in the mandible was the splint applied there instead. The splints were used at night during 7-8 weeks. At the last treatment session the patients were evaluated clinically and had to answer a standardized questionnaire. The patients who improved were followed up at 6 and 12 months after treatment. The participants who were not satisfied with the treatment outcome were offered additional treatment (Fig. 1). The patients not responding to acupuncture received oclclusal splints, and those not responding to occlusal splint therapy received acupuncture. Finally, those patients who did not respond to either treatment were transferred to various additional therapies, such as physiotherapy, intra-muscular and/or intra-articular mjections, occlusal adjustments, physiotherapy and occlusal adjustments, psychotherapy, detoxifications (analgetics, caffeine), and repositioning splint. All the patients were followed up 1 year after completed treatment. In accordance with the design of the study, five patient groups were formed (Fig. 1). Two of these groups received identical treatment, acupuncture and occlusal splint therapy; only the order differed. These patients were put in the same group. As a result, four groups were established and

377

Acupuncture and occlusal splints in CMD

ACTA ODONTOL SCAND 50 (1992)

Admittance Baseline Treatment

B -

A A+B

0

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7 Fig. 1. Distribution of the 80 patients at the follow-ups. A = acupuncture; B = occlusal splint therapy; AT = additional therapy; and MD = missing data.

7

6 months n=26 f o l ' o w - ~ ~ (MD n = 4) 12 months follow-up

n=23 (MD n = 5)

+

t

7

I Group A I IGroup D1 IGroup E

evaluated at the follow-ups: group A, acupuncture; group B, occlusal splint therapy; group D, acupuncture and occlusal splint therapy; and group E, additional therapy. Distribution of the patients at the followUPS

Of the 80 participants entering the study, 3 patients dropped out and 3 were excluded (3 in group A, 3 in group B). Two patients moved from the district, one patient died, one was not interested in continuing the treatment, one received extensive dental treatment, and one patient received physical therapy affecting the CMD symptoms. Of the 40 patients who first received acupuncture, 15 were transferred for occlusal splint therapy (10 immediately after treatment, 5 at the 6-month follow-up). Ten patients who did not benefit from either treatment received additional therapy. Of the 40 patients who first received occlusal splints, 12 were transferred for acupuncture treatment. Ten of these did not respond to either treatment and received additional therapy. The distribution of the patients in the four groups at the follow-ups is shown in Fig. 1. One patient in group A and two patients

I

n=5

I I

n=20

7

1 I II Group DI n=2

c

I Group B n=25

(MD n = 3)

I

in group B were not able to attend the 6month follow-up and only came to the 12month follow-up. One patient from each group had not completed the pain diaries and were excluded in the analysis of the intensity (visual analogue scale (VAS) index) and frequency (F) of pain at the 6month follow-up. At the 12-month follow-up 12 patients had not completed the pain diaries and were excluded in the analysis of the intensity (VAS index) and frequency (F) of pain. Of these patients, two belonged to group A, three to group B, two to group D, and five to group E. Assessment variables At each evaluation several measurements were used, including self-administered questionnaires, pain diaries, and clinical examination. Assessment variables 1 to 6 were described in detail in an earlier publication (22). Self-administered questionnaire: 1 ) anamnestic questionnaire (including Ai); 2) subjective evaluation of the treatment; 3) activity of daily living (ADL scale). Pain diary: 4) pain intensity (VAS index); 5) frequency of pain (F).

378 T. List & M. Helkimo

ACTA ODONTOL SCAND 50 (1992)

Table 1. Anamnestic index (A,): distribution of patients in groups A and B before, immediately after, and at the 6- and 12-month follow-ups Group B

Group A 0

I 7

6-month follow-up

O 8 7

7

7

12-month follow-up

7

4

11

A, Before Immediately after

I1

P

**}

**}T

P

0

I

I1

4 8

4 2

15 15

***

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NS p > 0.05; * p < 0.05; * * p< 0.01; ***p < 0.001.

Clinical examination: 6) clinical dysfunction score (CDS); 7) index for occlusal state (0,);8) incisal and occlusal tooth wear. 7) Index for the occlusal state. This index is based on the evaluation of the occlusion from the following four factors: number of teeth, number of occluding teeth, interferences in occlusion, and interferences in lateral excursions. The total scores from these registrations determined the occlusal state, ranging from 0 to 20 points (21). 0 points indicates no disturbance in occlusion or articulation; 20 points indicates severe disturbances. 8) Incisal and occlusal tooth wear. The degree of wear was determined in accordance with the following criteria (23): 0 = no wear or negligible wear of enamel; 1 = obvious wear of enamel or wear through the enamel to the dentin in single spots; 2 = wear of the dentin up to one-third of the crown height; and 3 =wear of the dentin more than one-third of the crown height; excessive wear of tooth restorative material

or dental materials on crown and bridgework, more than one-third of the crown height. Statistical methods Analysis of variance was used to test the significance of differences among groups when the variable was measured on a ratio scale. In case the analysis of variance rejected the multisample hypothesis of equal means, multiple comparison testing with the Newman-Keuls test was performed. A corresponding method for variables measured on an ordinal scale was the Kruskal-Wallis one-way analysis of variance followed by non-parametric multiple comparison testing. When data consisted of frequencies in discrete categories, the chi-square test was used to determine the significance of differences between independent groups. Two related samples were analyzed using paired t test for variables measured on a

Table 2. Subjective evaluation of the treatment: distribution of patients in groups A and B immediately after treatment and at the 6- and 12-month follow-up Group B (n = 25)

Group A (n == 22)

Completely well Much better Somewhat better Unchanged Somewhat worse Much worse

Immediately after

6-month follow-up

12-month follow-up

Immediately after

6-month follow-up

1 13 8 0 0 0

5 13 3 0 0 0

2 18 1 1 0 0

2 7 12 3 1 0

1 13 9 0 0 0

12-month follow-up 2

13 10 (I

0 0

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Acupuncture and occlusal splints in CMD

ACTA ODONTOL SCAND 50 (1992)

Table 3. Subjective evaluation of the treatment distribution of the patients in group E ( n = 20) immediately after the first treatment, before the additional treatment, and at the 12-month follow-up Immediately after

Before additional treatment

12-month follow-up

0 3 10

0 3 11 6 0 0

1 3 9

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Completely well Much better Somewhat better Unchanged Somewhat worse Much worse

ratio scale and the Wilcoxon matched-pairs signed-ranks test for variables measured on an ordinal scale. Association between two variables was estimated by using Pearson’s productmoment correlation coefficient. The multiple logistic model was used to explore the influence of prognostic factors on patients who were responders/nonresponders for each treatment method. Statistical tests were performed two-tailed and at the 5% significance level.

Results The study showed that those patients who responded well to treatment initially also responded well in the long run. The 25 patients in the occlusal splint group who responded well immediately after treatment continued to respond well during the 12month follow-up period. In the acupuncture group 27 patients had responded well immediately after treatment. Of these, five had relapsed at the 6-month follow-up and one more had relapsed at the 12-month follow-up. This means that of all the patients taking part in the study, 21 (57%) in group A and 25 (68%) in group B remained clinically and subjectively better at the 12-month follow-up. In both groups all patients showed a significant reduction in all assessment variables at the 12-month follow-up. No statistically significant difference was found between the groups. An improvement was seen in only a few cases in groups D and E.

7 0 0

7 0 0

Follow-ups: group A (acupuncture), B (occlusal splint), and E (additional therapy) The anamnestic index. The Ai was significantly reduced in group A but not in groups B and E immediately after treatment as compared with the index before treatment. This reduction was significant at the 6- and 12-month follow-ups in groups A and B (Table 1). Before additional therapy was initiated, the patients in group E did not show any significant change in the scores of the Ai. After additional therapy a significant (p < 0.01) improvement was found at the 12month follow-up. Subjective evaluation of the treatment. Immediately after treatment all the patients in group A and all but four in group B had improved. At the 6- and 12-month followups all but one patient in group A and all patients in B felt somewhat better, much better, or completely well (Table 2). In group E 13 patients reported feeling better immediately after treatment. At the 12month follow-up, results were similar (Table 3). ADL scale. A statistically significant reduction of the ADL index was found immediately after treatment for group A ( p < 0.01) but not for group B. At the 6-month follow-up, significant reductions ( p < 0.001) were found for both groups A and B. At the 12-month follow-up the ADL index was significantly reduced for both groups A ( p < 0.01) and B ( p < 0.001) (Fig. 2a). In group E no significant differences were found at any of the follow-ups as compared with the situation before additional treatment.

T. List & M. Helkimo

380

ACTA ODONTOL SCAND 50 (1992)

ADL_/ 10

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4

T

T

NS NS

NS

T T

T

T I a"

Before

6 Months

Immediately after

T,

I I

12 Months

10

GroupA

I

GroupB

T

3iT

NS

T

-

NS NS

TT

T

~~~

b"

Before

Immediately after

6 Months

Pain intensity (VAS index). A significant reduction ( p < 0.001) of the VAS index was found immediately after and at the two follow-ups for both groups A and B as com-

12 Months

Fig. 2a. Activity of daily living (ADL). 2b. Pain intensity (VAS index). Mean values and SD before, immediately after, and at the 6- and 12-month follow-ups for groups A and B. The statistical significance levels for the differences in treatment effects immediately after and at the two follow-ups as compared with before treatment are shown in each bar. (NS = p > 0.05; * p < 0.05; * * p < 0.01; *** p

Acupuncture and occlusal splint therapy in the treatment of craniomandibular disorders. II. A 1-year follow-up study.

Eighty patients, of whom 22 were men and 58 women, participated in a 1-year follow-up study. All participants in the study showed signs and symptoms o...
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