Clinical Rehabilitation

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Effects of acupuncture and placebo TENS in addition to exercise in treatment of

rotator cuff tendinitis
Mahnaz Razavi and Gunilla Brodda Jansen
Clin Rehabil 2004 18: 872
DOI: 10.1191/0269215504cr849oa

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Clinical Rehabilitation 2004; 18: 872-878

Effects of acupuncture and placebo TENS in addition

to exercise in treatment of rotator cuff tendinitis
Mahnaz Razavi, Kvarters Akuten Matteus, Physiotherapy Unit and Gunilla Brodda Jansen Department of Rehabilitation
Medicine, Karolinska University Hospital, Huddinge, Stockholm, Sweden
Received 9th October 2002, returned for revisions 4th February 2003; revised manuscript accepted 23rd May 2004.

Objective: To compare the effect of acupuncture with placebo transcutaneous

electrical nerve stimulation (TENS) when added to the exercise treatment of rotator
cuff tendinitis with respect to pain, shoulder movements and function.
Design: Prospective alternate allocation controlled trial.
Setting: Outpatient department.
Patients: Thirty-three patients (12 women and 21 men) were included in the study.
All had clinically diagnosed rotator cuff tendinitis.
Intervention: Both groups underwent a standardized training programme. Each
patient received in addition either 10 treatments with acupuncture or placebo TENS,
1-2 times per week.
Main outcome measures: The parameters investigated were intensity of pain
(measured with visual analogue scale), active, passive as well as functional
movements in the shoulder (hand in neck (HIN) and pour out of a pot (POP)). Patients
were tested before treatment, after treatment and at a six-month follow-up.
Medicine intake, ability to lie on the affected side and sleep disturbances were
evaluated. A subjective assessment was made after the treatment and at follow-up.
Results: Sixteen patients had acupuncture, 17 placebo TENS. Eight patients endured
pain at rest in the placebo TENS group, and 10 in the acupuncture group. After
treatment both groups improved, the improvement persisted at the six-month follow-
up. Both groups increased range of movement. Except for the functional test HIN in
the acupuncture group, there were no differences between the groups regarding
other parameters investigated directly after treatment or at six-month follow-up.
Conclusion: There is no difference between the effect of additional acupuncture
treatment and placebo TENS in the treatment of rotator cuff tendinitis.

Introduction structures are the predominant causes of shoulder

Rotator cuff injuries and impingement are com-
mon causes of pain and restriction of movement in
the shoulder joint." 2 Inflammation and degenera-
tive changes in the rotator cuff and adjacent
Address for cor-respondence: Mahnaz Razavi, Kvarters Akuten
Matteus, Physiotherapy Unit, Surbrunnsgatan 66, SE-1 13 27,
Stockholm, Sweden. e-mail: mahnaz.razavi@kvam.nu
4 Arnold 2004
pain. 3 For about one-third of patients with
painful arc (painful abduction between 70 and
120 degrees), the pain is caused by disorders in the
supraspinatus tendon, but degenerative changes in
the acromio-clavicular joint are also common.4
The most common symptoms in rotator cuff
tendinitis are pain related to movement, muscular
weakness and reduced mobility in the shoulder
joint. Upon clinical examination, tenderness can
10. 1 J 91/026921 5504cr849oa

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 Acupuncture fbr rotator culff tendinitis 873

be found over the supraspinatus tendon.23 Pain
during the night is also a common symptom and
the patient often finds it difficult to sleep on the
affected shoulder.2
Rotator cuff tendinitis is a common reason
for patients to consult a physiotherapist. Phy-
siotherapeutic treatment such as cooling, ultra-
sound, transcutaneous electrical nerve stimulation
(TENS) and training are the most common
methods of treatment.
One other method of peripheral sensory stimu-
lation for treatment of musculoskeletal pain, such
as rotator cuff tendinitis, is acupuncture, but few
studies have been carried out focusing on acu-
puncture and shoulder pain. Previous studies6'7
have reported positive results, but the diagnostic
criteria vary, and the study design is often poor.
The purpose of this study was to evaluate the
effects of acupuncture treatment as a supplement
to training, compared with placebo TENS treat-
ment and training in patients with rotator cuff
tendinitis, with respect to pain and movements in
the shoulder joint.
Method
Forty patients with shoulder pain were initially
enrolled in the study. The patients were recruited
from general practitioners and orthopaedic sur-
geons, or applied individually in response to
advertisements. Three patients were excluded
from the study due to incorrect diagnosis and 37
patients with the diagnosis rotator cuff tendinitis
were included in the study (Figure 1).
Another four patients (three women and one
man) did not complete the treatment due to lack of
time, incorrect diagnosis or illness in the family.
The result of the study is based on the 33 patients
who finally completed the treatment.
Inclusion criteria were pain on palpation, iso-
metric contraction and passive stretching in at
least one of the rotator cuff muscles. Two of the
criteria were required for the patient to be included
in the study. Exclusion criteria were cervical
rhizopathy, damage in any of the rotator cuff
tendons, or magnetic resonance imaging (MRI)
or X-ray that indicated other painful conditions in
the shoulder. The first patient was included in the
acupuncture group (group I). Thereafter, the
patients were allocated to two groups alternately,
placebo TENS (group II) serving as control.
On the first visit, the patients were informed that
two different forms of treatment were to be
performed, that they could remain on their regular
medication, and that the treatments were free of
charge. The patients were also examined by one of
the authors (MR) and a case record was created.
There was no significant difference between the
two groups regarding age, sex, duration of
shoulder pain, affected side, reason for shoulder
pain (trauma/strain/spontaneous) and previous
treatment (Table 1).
Both groups received a standardized training
programme. The traning consisted of specific
strength and endurance exercises of the rotator
cuff muscles including elastic bands and dumb-
bells. The traning programme was put together by
Table 1 Background data of the patients in the two
treatment groups

Acupuncture Placebo TENS

(n= 16) (n= 17)
Sex: women/men 4/12 8/9
Age, median (range), 49.5 (27-77) 53 (28-61)
years
Affected side: Right/ 11/5/0 7/7/3
left/bilateral
Duration of shoulder 12 (0.5-168) 12 (0.5-240)
pain, median (range),
months
Reason for shoulder 4/10/2 2/12/3
pain: trauma/strain/
spontaneous
Previous treatment: 10/6 11/6
yes/no
Figure 1 Flow diagram of patients.

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874 M Raz,avi and GB Jansen
the authors after a review of the literature.8 -3
Each patient received 10 treatments 1-2 times/
week, which included training and acupuncture or
placebo TENS treatment.
Group I received manual acupuncture supple-
mentary to training. The needles were sterilized
single-use needles 0.30 x 30 mm (Seirin). The
selected points were GB 21, LI 15, 11, 4, TE 14,
SI 9, 10, 13, ST 38, according to experience and
literature.'4 The treatments were given by a physi-
cal therapist (MR). The number of needles used
varied between six and nine. The treatments were
carried out for 30 min, with three manual stimula-
tions during each session.
Group II received placebo TENS supplementary
to training, i.e., switched-off TENS apparatus.
Four electrodes, 50 x 35 mm were placed dorsally
and ventrally over the shoulder, with the stimulator
out of sight for the patient. The apparatus was
switched on with a nonperceptible stimulation for
15 min, the patient was informed that they would
not feel anything during treatment.
All patients were asked to register medication
intake, whether he or she could lie on the affected
side, and about sleep disturbances.
All parameters were examined before the treat-
ment period, after the last treatment, and at the
six-month follow-up. The patients were examined
by an independent investigator, who was blinded
with regard to the treatment given. The intensity of
pain was measured with a visual analogue scale,
(VAS scale 0- 100 mm), both during rest and
functional movements. Active and passive move-
ments of the shoulder joint were measured with a
goniometer (Medema, Stockholm, Sweden) in
flexion and abduction. Functional movements of
the shoulder were tested according to the hand in
neck test (HIN scale 0-5) and pour out of a pot
test (POP scale 0-4). The POP test involves
isometric postural fixation of the upper arm in
moderate forward flexion combined with an eccen-
trically performed internal rotation."5 The HIN
test includes three components, active abduction
and external rotation of the humerus and retrac-
tion of the shoulder. 16 The patients also made their
own assessment regarding rate of improvement.
At six-month follow-up the patients were also
asked whether they had received any further
treatment or taken medication against shoulder
pain, and about their training habits.
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The study was approved by the Local Research
Committee, Karolinska Hospital, Stockholm,
Sweden.
The following statistical methods were used:
* Friedman test for comparison of VAS within
groups.
* Mann-Whitney U-test for comparison between
groups and Wilcoxon's sign test for two mea-
surement occasions per individual.
* Fisher test for comparison between groups for
HIN and POP.
The significance level was set at p <0.05(*),
p < 0.01(**), p < 0.00l(***).
Results
Thirty-three patients completed the study, 16
patients in the acupuncture group and 17 patients
in the placebo-TENS group (Figure 1). All patients
reported movement-related pain before treatment.
Eight patients out of 17 endured pain at rest in
the placebo TENS group before treament, in the
acupuncture group 10 out of 16 patients reported
pain at rest before treatment. Both groups im-
proved regarding pain at rest after the treatment
period as well as at the six-month follow-up (p <
0.001); no differences were noticed between the
groups.
There was no significant difference between the
groups regarding active as well as passive move-
ments of the affected shoulder; both groups
improved throughout the observation period
(Figures 2 and 3).
There was no difference between the groups with
regard to POP during the investigation period.
Regarding HIN, the acupuncture group improved
compared with the placebo TENS group after
treatment (p <0.01), but there was no difference
between the groups at the six-month follow-up
(Table 2).
Fifteen patients in the placebo TENS group and
14 patients in the acupuncture group did not use
any medication when entering the study. The rest
of the patients reported medication intake between
1 and 1 measured in medication units (each tablet
considered as one unit). At six-month follow-up
 Acupuncture fir rotator cuff tendinitis 875
200 ** *
**
** ** * *
*
*

175
9
150

125

100
0 Active flexion b.t.
75 A Active flexion a.t.
Active flexion 6m
U
50 Passive flexion b.t.
0
Outliers
25 Extremes
A Passive flexion a.t.
0
Placebo TENS Acupuncture Passive flexion 6m

Figure 2 Results of active and passive flexion measured in degrees, before treatment (b.t.), after treatment (a.t.) and at six-
month follow-up (6m).

none of the patients used any medication on
regular basis.
Eight out of 17 patients in the placebo TENS
group reported pain lying on the affected shoulder
before the treatment. After completed treatment,
only three patients reported pain, at the six-month
follow-up all patients were able to lie on the
affected side. In the acupuncture group six out of
200
**
seven patients with reported pain improved; at six-
month follow-up three patients reported pain.
Ten patients in the placebo TENS group and 10
patients in the acupuncture group reported sleep
disturbances before treatment. Nine patients in the
placebo TENS group and eight patients in the
acupuncture group reported improved sleep after
the treatment period. At six-month follow-up
* ***

175 TIMM... ........

o0
....... _L
...... ............... ......... ................ ........... .......................

o Active abduct. b.t.

a Active abduct. a.t.
O Active abduct. 6m
* Passive abduct. b.t.
c A Passive abduct. a.t.
* Passive abduct. 6m
o Outliers
0
Placebo TENS Acupuncture + Extremes

Figure 3 Results of active and passive abduction in degrees, before treatment (b.t.), after treatment (a.t.), and at six-month
follow-up (6m).

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876 M Ra:atvi and GB Jansen
Table 2 Evaluation of functional movements after treatment (after) and at six-month follow-up (6m)
Acupuncture (n = 16) Placebo TENS (n = 17) Difference between groups
POP
Not improved after/6m 5/2 6/2 ns/ns
Improved after/6m 8/7 8/7 ns/ns
Pain-free after/6m 3/7 3/8 ns/ns
HLN
Not improved after/6m 1/4 8/3 ns/ns
Improved after/6m 9/3 5/7 p < 0.01/ns
Pain-free after/6m 6/9 4/7 ns/ns

seven patients in the placebo TENS group and six 1-2 times/week together with the training pro-
patients in the acupuncture group reported im- gramme.
proved sleep. The result demonstrated reduction of pain at
The majority of the patients in both groups in both groups after treatment, an effect which
rest
continued training once or twice weekly after the persisted at six-month follow-up in both groups
study period. (p < 0.001). Active as well as passive movements in
At six-month follow-up, two of 17 patients in the flexion and abduction were significantly improved
placebo TENS group had received other treat- on the affected side in both groups after the
ment; anti-inflammatory drugs orally, or cortisone treatment period; the result remained at six-month
injection in the shoulder joint. No patient in the follow-up. Regarding POP, both groups improved
acupuncture group had received any other treat- and there was no difference between the groups.
ment, one patient in the acupuncture group The improvement in the functional test (HIN)
reported 'no improvement'. Self-rated assessment however, was only demonstrated in the acupunc-
after treatment and at six-month follow-up is ture group after treatment (p <0.001), but the
presented in Table 3. difference between the groups did not remain after
six months. Thirty-two out of 33 patients improved
regarding self-assessment, and no difference be-
tween the groups was demonstrated.
The results of this study do not show any
Discussion beneficial effects of acupuncture on rotaor cuff
tendinitis in comparison with placebo TENS. The
In this sudy, 33 patients with rotator cuff tendinitis natural course of rotator cuff tendinitis may
were treated with either acupuncture or placebo explain the improvement in patients after training,
TENS in addition to a standardized training although a majority of the patients in this study
programme, in order to evaluate the effect of had suffered from pain over a long period of time
sensory stimulation such as acupuncture and (0.5-240 months). The majority of the patients
placebo TENS on shoulder pain and function. continued with controlled training after complet-
Pain duration varied between 0.5 and 240 months, ing treatment, suggesting that training has bene-
median value of 12 months. The patients were ficial effects in these patients.
allocated either to acupuncture or placebo TENS The shortcoming of the study is the lack of a
alternately. Each patient received 10 treatments, proper placebo group, and it has become evident
Table 3 Self-rated assessment after treatment (after) and at six-month follow-up (6m)
Slightly improved Improved Good Very good n
Placebo TENS after/6m 2/1 7/4 4/6 4/6 17
Acupuncture after/6m 2/3 4/2 5/4 5/6 16
Both groups after/6m 4/4 11/6 9/10 9/12 33

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Clinical message
* Acupuncture has no or little effect
rotator cuff tendinitis in comparison to
placebo TENS.
that placebo-controlled studies should include a
third group without treatment for improved classi-
fication of acupuncture effects. Although placebo
TENS would serve as an ineffective treatment, it
does not resemble the true qualities for a placebo
procedure.
It has been difficult to find proper control
to acupuncture treatment. Attempts have been
made with sham acupuncture or placebo TENS.
Streitberger and Kleinhenz recently introduced a
placebo needle for acupuncture.17 When carrying
out this study, placebo needles could have been
used as a control. However, we opted for placebo
TENS as a placebo treatment since investigations
have demonstrated that the mechanical pressure of
the needle itself can activate afferent nerves. Recent
studies have demonstrated that a mechanical pain-
free stimulation may activate the nociceptive path-
way system.'8
Studies by Han-Zhen and Chun-Zhou6 and
Marcus and Gracer7 have shown good results for
acupuncture treatment on both pain and mobility
in the shoulder joint. In Han-Zhen's study, how-
ever, it is difficult to apply a correct diagnostic
discussion. Lack of control group in either of the
studies also reduces the importance of the positive
outcome of acupuncture. Studies by other investi-
gators'9 20 have demonstrated no difference be-
tween treatment and placebo. This is in line with
our study where specific training seems to be more
relevant for the improvement than sensory stimu-
lation per se.
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