3 treament intervention in frozen shldr

Annals of the Rheumatic Diseases, 1984, 43, 353-360

Frozen shoulder: prospective clinical study with anevaluation of three treatment regimensD. Y. BULGEN, A. I. BINDER, B. L. HAZLEMAN,J. DUTTON, AND S. ROBERTS

From the Department of Rheumatology Research, Addenbrooke's Hospital, Hills Road,Cambridge CB2 2QQ

SUMMARY Forty-two patients with frozen shoulder were followed up closely for eight months.They were all taught pendular exercises and randomly allocated to one of four treatment groups:(a) intraarticular steroids, (b) mobilisations, (c) ice therapy, (d) no treatment. This study hasshown that there is little long-term advantage in any of the treatment regimens but that steroidinjections may benefit pain and range of movement in the early stages of the condition.

Frozen shoulder is a rheumatological enigma. Pre-cise definition varies, response to the many recom-mended treatments is often capricious, and many ofthe published reports are difficult to interpretbecause they are based on small series or containinadequate clinical or treatment details.A wide variety of treatments have been investi-

gated, including local1 2 or oral3 steroids, manipula-tion under anaesthesia (MUA),4 5 stellate ganglionblock,6 physiotherapy,7 infiltration brisement, andradiotherapy.9 There is no general agreement infavour of one form of treatment, and the response toa particular treatment varies in different series. Thevalue of local steroid injections may be taken as anexample. In a retrospective study Hazleman10 couldnot show any difference between local steroidinjection, MUA, and physiotherapy. Similarly, butin a prospective study, Lee et al.11 found nosignificant advantage of local steroid injection plusphysiotherapy against heat plus physiotherapy.However, Roy and Oldham'2 have reported localsteroid injections to be highly effective in patientswith painful, generally restricted shoulders. Quin2also found steroid injections to be effective, but henoted that the improvement in pain and range ofmovement was short-lived. Treatment regimensshould be judged against natural recovery, which isoften slow and incomplete. Simmonds13 studied 21patients for more than three years. Nine hadpersistent weakness and pain, six had weakness or

Accepted for publication 19 November 1983.Correspondence to Dr B. L. Hazleman.

loss of movement, and only six regained normalfunction.

Whether any clinical features such as mode ofonset can predict or influence the eventual outcomealso remains unclear. Hazleman10 found early pre-sentation but not severity or type of onset (spon-taneous or traumatic) to influence the recoverytime. Clarke et a114 reported a trend for young malesand dominant arm involvement to be associatedwith a less favourable prognosis. As both the studieswere performed retrospectively, interpretation ofthese trends is difficult. Feamley and Vadasz15noted that patients with a raised sedimentation rateresponded better to steroid injections. However,they were unable to show that the duration ofsymptoms at presentation or the mode of onsetaffected the prognosis.Our aim was therefore, firstly, to study a carefully

defined patient group and assess three treatmentregimens against non-treatment over a long period.

Patients and methods

Forty-five patients entered the study, but three weresubsequently withdrawn: one developed very acutepain after an arthrogram, one obtained physiother-apy elsewhere, and one failed to attend. Forty-twopatients, 28 females and 14 males, with previouslyuntreated frozen shoulder completed this study.Criteria for inclusion were pain in the shoulder for atleast one month, with sleep disturbance due to nightpain and inability to lie on the affected shoulder. Allactive and passive shoulder movements were res-

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354 Bulgen, Binder, Hazleman, Dutton, Roberts

tricted, with a reduction in external rotation of atleast 50%. Patients with any sensory symptoms orsigns in the affected arm or radiation of pain to theneck were excluded. Patients with generalisedarthritis, fractures, or dislocations of the humerus,cervical spondylosis, or evidence of referred painwere also excluded.

Twenty-two involved the dominant arm and onlyone became bilateral. The onset was spontaneous in27 cases and followed minor trauma in 14 patients.Twelve of the patients were manual workers, butthis did not influence the arm involved. Althoughthe frozen shoulder followed a herpes zoster infec-tion of the T8 dermatone in one patient, no otherknown precipitating factors such as strokes, myocar-dial infarctions, or diabetes mellitus were present.The age range was 44-74 years (mean 55.8), and

the duration of the condition at presentation was1-12 months (mean 4.8). Fig. 1 shows the distribu-tion of age, sex, and disease duration beforetreatment.

Clinical assessment was performed before treat-ment, weekly for 6 weeks and monthly for a further6 months by an independent observer who was notaware of the treatment given.

Pain scores were recorded on 10 cm visualanalogue scales for night pain, pain on movement,and rest pain during the day. Patients were alsoasked to state whether the various types of painwere better, the same, or worse.

The range of shoulder movements was measuredaccording to the method of Clarke et al.16 Thehydrogoniometer produced by Geigy was streng-thened and fitted with Velcro straps as they de-scribed. Only passive movements were recorded.Clarke et al. measured external and total rotation

Duration less than 3/12

Duration more than 3/12 LI

16-

14

12-

8-

4-

40 50 60

Age years

FEMALES

80 40 50 60 70 80

Age years

MALES

Fig. 1 Distribution of patients according to age, sex anddisease duration at presentation.

and glenohumeral abduction. We used the samemethod to measure also total flexion and abductionand glenohumeral flexion with the goniometerattached to the upper arm and the patient seated. Toassess glenohumeral range the shoulder girdle wasstabilised by firm downward pressure over theacromion process. Internal rotation was recorded asthe vertebral spine reached by the extended thumb.Clarke et al. recorded measurements to the nearest20. We found it more reproducible to measure to thenearest 50. The measurements were performedtwice, and if they differed by more than 50 they wererepeated once more and the mean of the closest twoobservations was taken. Measurements were alwaystaken before and not after a physiotherapy session.Similar measurements were taken of both shouldersof 42 age- and sex-matched healthy controls and 36other controls of a similar age group to provide anormal population sample.

TREATM ENTThe patients were randomly allocated to one of fourtreatment groups.

(1) Steroid group (11 patients). Methyl predniso-lone acetate 20 mg and 1% lignocaine hydrochloride0-5 ml were injected into the subacromial bursa anda similar amount into the shoulder joint by theanterior route, weekly, for three weeks.

(2) Mobilisation group (11 patients). Maitland'smobilisations17 were given by a research physiother-apist to these patients, three times weekly for sixweeks.

(3) Ice group (12 patients). Ice packs followed byproprioceptive neuromuscular facilitation (PNF)was supervised by the same research physiotherapistwith a similar time schedule to the mobilisationgroup.

(4) Non-treatment group (8 patients).All patients were taught pendular exercises and

advised to do them for 2-3 minutes every hour.Non-salicylate analgesics and diazepam 5 mg atnight were available as required.

Results

CLINICALThirty-nine patients reported excellent generalhealth, one had a chronic duodenal ulcer, anotherhad hyperventilation syndrome, and one womanwas hypertensive with a history of depression. Fivepatients had previously suffered from a painful stiffshoulder on the opposite side. Despite their age theywere a very fit group of patients with little pastillness.The patients' occupations were as follows: 12

were engaged in heavy manual labour and 8 light

a-


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Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens 355

manual labour, 15 were housewives, and the otheihad sedentary occupations. There was no assocition between heavy manual work and dominancethe frozen shoulder. Three patients were unablework because of the frozen shoulder. They includa carpenter, a nurse, and a hairdresser. A railwworker found that physiotherapy (ice) exacerbathis pain and was then off work for two months. Aother patients remained at work.The initial drug treatment prescribed by genel

practitioners is shown in Fig. 2. It can be seen thhalf the patients were given a non-steroidal aninflammatory drug NSAID but only 3/21 patierfound the drug helpful. An analgesic was fouihelpful by 5/10 patients. Ten patients were nprescribed any drug therapy. By the time the patiecame to clinic the drug therapy had changed (Fi3). Only six patients were taking NSAIDs, 19 hbecome disillusioned and were not taking anythinand three patients were taking simple analgesic

During the study 12 patients did not take a]drugs, 26 took simple analgesics for varying lengtof time, but mainly during the first six weeks. Eigpatients with severe night pain were prescribdiazepam 5 mg at night, and all reported sonbenefit. Again, they mainly took it during the filsix weeks. At the end of the study one patient wstill taking an occasional Distalgesic tablet (dextrpropoxyphene and paracetamol) and one patierequired diazepam 2 mg b.d. and 5 mg nocte plParamol-118 (paracetamol) tablets 2 nocte. So f

NSAID

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Fig. 2 Initial drug treatment prescribed by generalpractitioners (NSAID=non-steroidalanti-inflammatory drug).

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nt Fig. 3 Drug treatment at outpatient appointment.ig. (NSAID=non-steroidal anti-inflammatory drug)adig, as initial physical advice by general practitioners wasny concerned, none was given to 28 patients, 2 were

hs told to rest the shoulder, 6 were told to exercise itht through pain and the remaining six were advised to'ed use the shoulder normally but to avoid strain.ne On examination all patients had very limitedrst shoulder movements: mean total flexion 990 (range(as 50°-135°), mean glenohumeral flexion 510 (rangero- 40°-70°). mean total abduction 690 (range 20°-135°),nt mean glenohumeral abduction 400 (range 0°-70°),[us mean total external rotation 130 (range 0°-35°), andFar mean total rotation 410 (range 0°-100°). Sixteen

patients were found to have pain on resistedmovements, and a further nine patients had local

18 tenderness mainly over the tuberosities, but they* appeared to be no different from the other patients

so far as the pattern of recovery was concerned. Halfof the patients presented within three months of theonset of the disease and the rest later (Fig. 1). Thepatients seen early complained of slightly more painat rest and at night than the other patients, but thedifference did not reach statistical significance.

Initial range of movement was similar in bothgroups.

PAIN MEASUREMENTIt was noted that many patients found difficulty intranscribing their verbal descriptions of pain to thevisual analogue scales, so that by the end of thestudy we felt that little reliance could be placed onany detailed analysis of these scales. However,verbal reports of progress seemed more consistentand reliable.

All patients reported an improvement in painduring the study, but 17 still had residual pain at theend of it, usually mild, but moderate in four.Residual pain was commoner in the ice group,

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affecting half the patients, but was equally distri-buted in the other groups. All types of pain were stillexperienced-rest pain, night pain, and pain onmovement. The maximum improvement in pain wasachieved by the fourth week of treatment and thencontinued slowly after that. This was most obviousin the steroid group, but did not reach statisticalsignificance.

SHOULDER MEASUREMENTRecovery curves were plotted for each movementshowing the average improvement in degrees be-tween consecutive visits in each treatment groupagainst time (Figs. 4-7). These were further ana-lysed by the method described by Lee et al.1

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Component analysis was used to compute a princi-pal component, C, which accounted for 59% of thetotal variation between the patients initially. Thiswas equal to: C=(0.536 x total flexion) + (0.201 xglenohumeral flexion) + (0.679 x total abduction)+ (0.263 glenohumeral abduction) + (0.079 xexternal rotation) + (0.369 x total rotation) -137-7.The component C was calculated for each patient

at each time, and the cumulative effect was plottedas for the individual measurements. It can be seenthat a low value for C represented a poor range ofmovement and a higher value an improvement.Thus we were able to draw a cumulative recoverycurve (Fig. 8).

__.4*-

KEY

*........

* ---

SteroidMobilisationIcePlacebo

Fig. 4

Figs. 4-7 Recovery curves showing averageimprovement in degrees between consecutivevisits for total flexion (Fig. 4), total abduction(Fig. 5), external rotation (Fig. 6), and totalrotation (Fig. 7).

SteroidNobilisationIcePlacebo

Fig. 5

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WEEKS MONTHS

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Steroid*......... NIobilisation._- - -oIce.-. Placebo Fig. 8 Improvement in

cumulative principal component.

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TREATMENTFrom the graphs (Figs. 4-8) it can be seen that theinitial improvement in movement was most markedin the steroid group, but by the end of the study thegroups were similar. This was confirmed by per-

forming a one-way analysis of variance on theprincipal component figures. At six weeks-i.e., theend of treatment-the groups were significantlydifferent at the 2% level, but by the end of the studythere was no significant difference between thegroups.From the graphs it can be seen that the major

improvement in range occurs within the first fourweeks, suggesting that a course of treatment shouldbe limited to this length of time and that localsteroid injections should be the initial treatment ofchoice.

OTHER FACTORSThe principal component C was also used to assess

the effect of other factors on the rate of recovery ofrange as long as these factors were equally distri-buted in the treatment groups. Thus it was found byan unpaired t test at six weeks and at the end of thestudy that there was no significant difference in the

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WEEKS MONTHS

Fig. 9 Effect of early and late presentation on recoveryof range. Presentation at three months or earlierat later than three months v - -0.

rate of recovery of shoulder movement whether thedominant or the non-dominant shoulder wasaffected. Similarly, presentation before or afterthree months had no statistically significant effect onthe recovery of shoulder movement at six weeks andat the end of the study, although from the graph(Fig. 9) it appears that the early presentation grouphad a better initial response. There was also norelationship between the principal component at thestart of the study and at the end. Thus the initialseverity of restriction gave no indication of the finaloutcome as far as range was concerned.

CONTROL MEASUREMENTSThe range of shoulder movement in our controls wascompared for right and left shoulders and fordominant and non-dominant shoulders by Student'st test (Table 1). No significant difference was found(p<005), but rotation and particularly flexion werebetter on the left or non-dominant shoulder andabduction was better on the right or dominantshoulder. Only 12 controls were left dominant, sothat the above comparisons could be expected togive very similar results.

Using the right shoulder of the 76 controls andignoring age, we compared the range of movementbetween males and females and found a significantlygreater range in females, for total abduction(p<002) total rotation (p<0-02) and external rota-tion (p<0-001) (unpaired t test with 48 DF). Totalflexion was not significantly different between thesexes. Performing a linear regression against agegave significant decreases (p<0.001) in the range ofall movements except external rotation. Externalrotation seemed to be poor in the youngest patients,under 50 years old. In view of the above findings acomparison between the same four measurements inour patients at 6 months after treatment was made

Table 1 Control shoulder measurement. Comparison ofright versus left shoulder and dominant versusnon-dominant shoulder

Mean t75 pr> t75

Comparison of right v. left shouldersTotal flexion (R-L) -0-7 -077 0-45Total abduction 0-5 0-53 0-60External rotation -0-9 -1-77 0-08Total rotation -1-4 -1-15 0-26

Comparison of dominant v.non-dominant shouldersTotal flexion (Dom-non-dom) -0-9 -0 99 0 33Total abduction 0-7 0-75 0-46External rotation -0-9 -1-77 0-08Total rotation -0-2 -0-16 0-87

R=right. L=left. Dom=dominant


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Table 2 Comparison between patients' range(post-treatment) against age and sex-matchedcontrols

Mean decrease (degrees)

Total flexion 27-8Total abduction 22-5External rotation 22-9Total rotation 63-8

Three comparisons were made, using controls' R and L, and sameR/L as patients' affected shoulder, and the least values recorded.

with age- and sex-matched controls, and all fourmeasurements were significantly lower in the pa-tients (p<00001), whether the controls' right or leftor same right or left, as the patients' affectedshoulders were used (Student's t test). Table 2 showsthe least reduction in range in the three comparisonsmade in our patients compared with the controls.Only four of the 42 (10%) patients had attained arange comparable with the minimum range of all thecontrols of similar age (assessed in each decade from40 to 70 years) and sex. Therefore six months aftercompletion of treatment our patients still had asignificant deficit in the range of shoulder move-ment, though the majority were pain free.

Discussion

It had been hoped that this study would identifyclinical subgroups in the frozen shoulder syndromedistinguished by clinical factors, immunolo¶fical'8,arthrographic, or technetium scan features l whichwould predict perhaps the likely rate of recovery orresponse to a specific treatment. Unfortunately thishas not happened.

In our study the spontaneous onset of frozenshoulder, although more common, could not bedifferentiated from the cases with preceding traumaby the severity of the initial pain, restriction in therange of movements, or the rate of recovery.

Hazleman,10 and later Oldham,'2 have suggestedthat early presentation is associated with a shortertotal duration. The patients whom we saw earlytended to improve rapidly, but this was not sus-tained, and there did not appear to be any long-termbenefit (Fig. 9).We have found less benefit from physiotherapy

compared with non-treatment than Lee et al, " butthey used a slightly different patient group in that16/25 patients had had a frozen shoulder for morethan one year, some for five years or more. Theirplacebo group was measured after six weeks, whilethe active treatment groups were measured weekly.

We saw all our patients weekly and gave themsimilar encouragement in order to minimise differ-ences between them.We found the method of measurement recom-

mended by Clarke et al. 14 reproducible and easy todo. We agree with Hazleman'slo finding that pa-tients often claimed that they had regained fullmovement, but objective testing showed that thiswas not so. Clarke et al.14 reported that recoverywas better when the non-dominant shoulder wasinvolved. We found the opposite to be true, butstatistical significance was not reached in eitherstudy. He also noted that 42% of his patients hadsignificant limitation of shoulder movement after sixyears. 90% of our patients had not attained a rangecomparable with the minimum range of a controlgroup of similar age and sex by 6 months follow-up,17% still having severe restriction.Our control shoulder measurements confirmed

the finding of Allander et al. 20 and Clarke et al. 6that females have a greater shoulder range thanmales but that there is no difference between rightand left shoulders or dominance.

In their study of the management of the painfulshoulder Roy and Oldham'2 included a group of 55patients with painful limitation of all shouldermovement and pain at night, similar to the patientsin our study. They reported an excellent response topaired steroid injections, and so we used similarsteroid dosage, frequency, and method of injectionto try to reproduce their results. The age range andthe duration of the frozen shoulder were similar inboth groups. The only obvious differences were thatwe used a smaller volume of lignocaine, injected theshoulder joint from the anterior route, and theshoulders of our patients were probably morerestricted. 95% of Roy and Oldham's patients werepain free eight weeks after they were first seen,having had two or three pairs of injections, but onlyfour out of 11 (36%) of our patients given steroidinjections were pain-free at that stage. Similarly, weachieved less improvement in the range of move-ment in our patients. The average pretreatmenttotal abduction was 72% and 60-5% respectively.73% or 44/60, shoulders in their series had achieved1500 or more within eight weeks of starting treat-ment, but only 18% or 2/11, of our patients hadachieved this after 10 weeks.

Obviously our steroid treatment results are muchless satisfactory than those of Roy et al.21, perhapsreflecting a different type of patient and differentmeasuring techniques, but we do agree with theirfinding that such an injection regimen is helpful.They stress the effectiveness of paired injectionsinto the subacromial bursa and the shoulder jointover injections into just one site, which may partly


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explain some of the differences in our resultscompared with those of the study by Lee et al.1"

This study has shown that there is little long-termadvantage in any of our treatment regimens over notreatment, but that steroid injections may benefitpain and range of movement in the early stages.There appears to be little place for physiotherapyalone, and, if used, it should not be continued formore than four weeks.

Significant range restriction, often unrecognisedby the patient, was confirmed in most of our patientssix months after treatment. Further follow-up wastherefore undertaken to determine the long-termoutcome.We thank the Arthritis and Rheumatism Council for support.

References

1 Lloyd Roberts G C, French P R. Periarthritis of the shoulder.Br Med J 1959; i: 1569-72.

2 Quin C E. Frozen shoulder: evaluation of treatment withhydrocortisone injections and exercises. Ann Phys Med 1965; 8:22-9.

3 Blockley N J, Wright J K, Kellgren J H. Oral cortisone therapyin periarthritis of the shoulder. Br Med J 1954; i: 1455-7.

4 Bloch J, Fischer F K. Frozen shoulder. Acta Rheumatol (Geigy)1961; no.15.

5 Thomas D, Williams R A. Smith D S. The frozen shoulder: areview of manipulative treatment. Rheumatol Rehabil 1980; 19:173-9.

6 Williams N E, Seifert M H, Cuddigan J H P, Wise R A.Treatment of capsulitis of the shoulder. Rheumatol Rehabil1975; 14: 236.

7 Mattingly S. Pain in the shoulder. Ann Phys Med 1960; 5:267-81.

8 Simon W H. Soft tissue disorders of the shoulder: frozenshoulder, calcific tendinitis and bicipital tendinitis. Orthop ClinNorth Am 1975; 6: 521-39.

9 Quin C E. Humeroscapular periarthritis: observations on theeffect of x-ray therapy and ultrasonic therapy in cases of 'frozenshoulder'. Ann Phys Med 1969; 10: 64-9.

10 Hazleman B L. The painful stiff shoulder, Rheumatol Rehabil1972; 11: 413-21.

11 Lee P N, Lee M, Haq A M M M, Longton E B, Wright V.Periarthritis of the shoulder-trial of treatments investigated bymultivariate analysis. Ann Rheum Dis 1974; 33: 116-9.

12 Roy S, Oldham R. Management of painful shoulder. Lancet1976; ii: 1322-4.

13 Simmonds F A. Shoulder pain with particular reference to the'frozen' shoulder. J Bone Joint Surg 1949; 31B: 426-32.

14 Clarke G R, Willis L A, Fish W W, Nichols P J R. Preliminarystudies in measuring range of motion in normal and painful stiffshoulders. Rheumatol Rehabil 1975; 14: 39-46.

15 Fearnley M E, Vadasz I. Factors influencing the response oflesions of the rotator cuff of the shoulder to local steroidinjection. Ann Phys Med 1969; 10: 53-63.

16 Clarke G R, Willis L A, Fish W W, Nichols P J R. Assessmentof movement at the gleno-humeral joint. Orthopaedics (Ox-ford) 1974; 7: 55-71.

17 Maitland G D. Peripheral manipulations. Butterworth: Lon-don, 1970: 25-51.

18 Bulgen D Y, Binder A I, Hazleman B L, Park J R.Immunological studies in frozen shoulders. J Rheumatol 1983;9: 893-8.

19 Binder A I, Bulgen D Y, Hazleman B L, Tudor J, Wraight P.Frozen shoulder. 3. An arthrographic and radionuclear scanassessment of the frozen shoulder. Ann Rheum Dis (sameissue).

20 Allander E, Bjornsson 0 J, Olafsson 0, Sigfusson N, Thor-steinsson J. Normal range of joint movements in shoulder, hip,wrist and thumb with special reference to side: a comparisonbetween two populations. Int J Epidemiol 1974; 3: 253-61.

21 Roy S, Oldham R, Nichol F E. Frozen shoulder: adhesivecapsulitis. Br Med J 1982; 284: 117-8.


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doi: 10.1136/ard.43.3.353 1984 43: 353-360Ann Rheum Dis

D Y Bulgen, A I Binder, B L Hazleman, et al. of three treatment regimens.clinical study with an evaluation Frozen shoulder: prospective

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3 treament intervention in frozen shldr

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