A. Objectives.The purpose of this study is to identify individuals 18 or older who have diagnostic
presentation of adhesive capsulitis and randomize them into two arms, distinguished by
use of physical therapy and steroid injections compared with steroid injections followed
by watchful waiting. This prospective study will be used to determine whether there is a
significant impact on patient outcome and whether the additional financial burden is
justified. The standard of care calls for initial non-operative therapy consisting of
NSAIDs, watchful waiting, and oral and parenteral corticosteroid administration with
consideration for operative therapy after 6 months of failed conservative therapy. We
would like to enroll patients who are willing to be randomized and postpone operative
therapy for a period of up to one year during which we would have scheduled follow up
visits at regular intervals. There are no experimental interventions for this study. The
use of physical therapy, oral and parenteral corticosteroids, and watchful waiting are
offered following the standard of care for adhesive capsulitis.
B. Background Adhesive capsulitis, also known as "frozen shoulder" is a common orthopedic
condition affecting 2-5% of the general population13. As defined by the American Academy
of Orthopedic Surgeons, it is a self-limiting condition resulting from any inflammatory
process about the shoulder in which capsular scar tissue is produced, resulting in pain
and limited range of motion.
The majority of shoulder function comes from the interactions of the glenohumeral
ligament complex, the rotator cuff complex, and the articulating bones. The superior
glenohumeral ligament is important in stabilization of the glenohumeral joint in
adduction and external rotation. The middle glenohumeral ligament is an important
stabilizing structure in the positions of adduction and external rotation and abduction
up to 45° in external rotation. The resistance, and therefore tension, of the inferior
glenohumeral ligament, which is negligible in positions of neutral adduction and
adduction in external rotation, increases in value for angles between 45° and 90°,
indicating the important stabilizing function of this ligament in those positions. The
rotator cuff is comprised of the tendons of the supraspinatus, infraspinatus, teres
minor, and subscapularis muscles1,10.
In this disease state, there is a capsular pattern of shoulder dysfunction which is
characterized by slight limitation of medial rotation, moderate limitation of passive
abduction, and most importantly, severe limitation of lateral rotation. The finding of
lateral rotation limitation or capsular pattern of limitation can be diagnostic in the
assessment of AC.
The rotator cuff is comprised of the subscapularis, biceps, supraspinatus, infraspinatus,
and teres minor muscles. The subscapularis muscle may be divided into nine bellies. The
muscle acts as the main internal rotator of the shoulder joint and provides support
against traumatic posterior dislocation. The supraspinatus is the main abductor of the
arm until 30° degrees after which the deltoid muscle takes over. It constitutes the
posterior margin of the rotator cuff interval. A fusion between the infraspinatus and
teres minor tendons is so common that the latter is sometimes considered the inferior
belly of the infraspinatus. Hence, the presence of a separate teres minor tendon should
be considered a variation. The infraspinatus acts in oppositions of the subscapularis as
the main external rotator of the arm and works in conjunction with teres minor in
completing this objective. Teres minor also assists with extension of the arm1,10.
Several shoulder scoring systems have been used to measure patient outcomes after surgery
and other therapies. These include the The American Shoulder and Elbow Surgeons
Standardized Shoulder Assessment (ASES), Disabilities of the Arm, Shoulder, and Hand
Questionnaire (DASH), and Constant-Murley Shoulder Outcome Score System. In addition,
physical exam findings, patient satisfaction, and return to athletics have been used to
further delineate outcomes. Our study will use the ASES, the DASH, and the Constant Score
System17.
Stages
- - Freezing (inflammatory): consists of the initial onset of pain and loss of
range of motion that can last anywhere between six weeks to nine months7.
2.
- - Frozen: may show an improvement in pain, but a worsening in range of motion and
generally lasts from four to six months7.
3.
- - Thawing: consists of a resolution of symptoms with partial or full return of
function that can take between six months to two years7 The most commonly
affected demographic is adults in their fourth to sixth decade of life with a
median onset of 55 years old and a high incidence in women than men.
The
condition generally presents unilaterally with the non-dominant shoulder more
commonly affected and a progression to bilateral presentation within 5 years in
6 to 17% of patients.16,18,22¬ The aim of treatment is bimodal with one aspect
being the resolution of pain and the other being improving range of motion.
Common treatments include NSAIDs, oral corticosteroids, intra-articular
corticosteroid injection with and without anesthetic, as well as intracapsular
distention with and without corticosteroids.
Corticosteroid injections
- - A randomized pilot study in 2009 showed that there were
clinically significant improvements in all aspects of function and quality of life for
those patients undergoing corticosteroid injections, with no statistically significant
difference between patients who underwent capsular distension21.
The use of injections in
the short term has been proven efficacious in the short term in alleviating pain and
increasing ROM. The utility of steroids in the long term has been called into question by
a 2008 prospective study that showed that the comparison of steroid injections and
physical therapy to physical therapy alone yielded no change in end result2.
Short wave diathermy and manipulation under anesthesia (MUA)
- - Uses radio frequency
energy to generate heat in tissues, which has an analgesic effect and reduces muscle
spasm and joint stiffness.
In one study, short-wave diathermy was showed in randomized
control trials to improve outcomes compared to general home exercise16,22.
Physical therapy
- - Maitland mobilization physiotherapy was observed in a single case
design to provide increased quality of life, but no significant objective changes in
functional status15.
Another prospective outcome study evaluating patients who underwent
non-operative treatments showed simple home exercise programs to positive outcomes even
in patients who had had previously failed attempts at resolution through intensive
physiotherapy15,20.
Watchful waiting
- - A wait and see approach, which has been shown to improve outcomes over
intense physiotherapy in some cases by being favorable in achieving near pain free
function within 24 months.
Systematic review in 2012 reviewed nineteen databases in the UK for cost efficacy of
various interventions made no significant claims as to which interventions were the most
economically advantageous proposing a multi-arm trial comparing high quality conservative
management, steroid injection, steroid injection in conjunction with capsular distension,
capsular release with MUA16. With growing costs of healthcare and the need to cut down on
extraneous interventions, the role of physiotherapy as an adjunctive measure should be
thoroughly evaluated.
While there have not been sufficient studies on the cost effectiveness as the
aforementioned review suggested, there was one study that addressed the use of
physiotherapy following capsular distension21. The conclusions garnered from the study
showed that the use of physiotherapy was not cost effective showing no beneficial
advantage in improving pain, function, or quality of life5,15,19.
By determining the objective contribution physiotherapy has on the resolution of adhesive
capsulitis when compared to operative management, several protocol related
inconsistencies can be elaborated upon. The purpose of this study will be to compare and
contrast the benefits yielded from the use of adjunctive physiotherapy in patients who
undergo conservative management of adhesive capsulitis. This will provide a basis from
which to evaluate whether it is an economically effective use of resources. If the impact
is found to be negligible in the long term resolution of adhesive capsulitis, this
study's results can be used to advocate for alternative therapies that could avoid the
cost of innumerable assets.
