Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment

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 -

1. - 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.

Inclusion Criteria:

- Patient must be 18 years or older

- Must meet the following definition for adhesive capsulitis as defined by the American
Academy of Orthopedic Surgeons: 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; also called frozen shoulder

- Must be amenable to randomization into either cohort

Exclusion Criteria:

- Non-English speaking patients

- Pregnant women (women of childbearing potential will be advised to undergo regular
pregnancy testing)

- Patients who had previously undergone operative therapy for the condition