STUDY OBJECTIVES The primary objective is to evaluate the effect of combination of regional
anesthesia and physical therapy measured as an improvement in pain related disability scores
of the impaired shoulder using the Shoulder Disability Questionnaire (SDQ), Shoulder Pain and
Disability Index (SPADI), and improvement in pain score measured by Brief Pain Inventory
(BPI).
The secondary objectives are to evaluate the effect of treatment on the following:
Anxiety, measured by General Anxiety Disorder Questionnaire (GAD-7)
Depression, measured by Beck's Depression Inventory (BDI)
Satisfaction, measured by Global Improvement and Satisfaction Score (GISS) STUDY DESIGN
This is as a single-center, prospective cohort study. The study does not imply any new
intervention; all decisions regarding the treatment will be made at the sole discretion
of the treating physician as part of clinical care. The study will be conducted over a
period of 14 months, including approximately 1-2 months of enrolment, 4-6 weeks of
treatment and follow-up at 3, 6, 12 months after the initiation of treatment for frozen
shoulder. Treatment 1 can be scheduled along with baseline consult and screening (Day
0), three to five more treatment visits (Treatment 2 to Treatment 6) will be scheduled
weekly (4-6 treatments in total), and follow up visits on 3, 6, and 12 months (with
±1week window). If patient has achieved any early full ROM, treatment will be stopped
according to the physicians' decision. The study will be conducted at the Allevio Pain
Clinic, Toronto, Canada. Research Ethics approvals will be sought.
STUDY POPULATION Patients with unilateral or bilateral frozen shoulder in any stage will be
screened for study eligibility.
STUDY INTERVENTION
1st part of treatment: (by Anesthesiologist) Treatment will be provided to all eligible
patients at baseline visit (Day 0). In the procedure room, after exposing the affected
shoulder, the skin of the shoulder and neck on the affected area will be be prepared with the
mixture of chlorhexidine and alcohol. The position of the patient will be decided based on
the preference of the practitioner for performing brachial plexus block. Some of our
practitioners prefer to perform the procedure on supine position and some prefer lateral
position. Any difference in performing the brachial plexus block on supine or lateral
position is not expected. Furthermore, using a familiar position for the anesthesiologist
performing the brachial plexus block only adds to the safety of the intervention.
The anesthesiologist will use ultrasound and a sterile technique to perform two procedures:
In the first step, with the guidance of ultrasound, brachial plexus block (inter scalene
approach) will be provided. In total, 10 mL of a very dilute local anesthetic, marcaine
0.08 %, would be injected. The real-time guidance of ultrasound will be used to monitor
the whole procedure. By using an ultrasound guidance, the practitioner wiill make sure
that the local anesthetic has reached to all three nerve roots in inter scalene space.
In the second step of the procedure, the patient will be asked to sit up. In this step,
normal saline will be injected into the shoulder joint. The posterior approach will be
used with the real-time guidance of ultrasound. Depending on the compliance of the
shoulder joint, between 10-40 mL of normal saline will be injected. The target area for
normal saline is between the shoulder capsule and the head of the humorous. The goal is
to use the hydrostatic pressure to lift the capsule and separate the layers of adhesion
from the cartilage of the head of humorous.
The patient will stay in the recovery area for 15 minutes after both interventions are
performed. For the entire duration of both procedures, pulse rate, blood pressure, and oxygen
saturation in the room air will continuously be monitored every 5 minutes. Then the patient
will be moved to another area of the clinic to start physical therapy.
Physical therapy:
On the consult plus treatment day, assessment of the shoulder will begin in the seated
position. The range of passive external rotation will be measured with the elbow held tight
to the torso and bent at 90 degrees. Care will be taken to ensure that the patient does not
rotate at the trunk during external rotation of the shoulder. Manual palpation of the
coracoid process and deltoid insertion will be performed to check for pain and/or point
sensitivity.
The patient then will be placed in the supine position to check passive flexion and abduction
of the shoulder. Care will be taken to ensure the patient does not hike the shoulder towards
the ear during the passive abduction or arch the back during passive flexion, thereby
allowing evaluation solely of the rotator cuff. Due to the relatively small sample size and
working within a very active clinic environment, a visual estimation of the passive ROM will
be recorded in 20-degree increments.
After physical assessment and suitability confirmation, patients will be scheduled for 4-6
treatment appointments where they will undergo brachial plexus block and shoulder joint
injection by the anesthesiologist before passive mobilization performed by the chiropractor.
Each passive mobilization treatment will be generally 20 minutes in duration. Care will be
directed solely at the affected shoulder, and no other passive modalities will be applied
other than manual mobilization. The patient will be given three home based exercises to
perform. These exercises are pendulums, passive external rotation against a door frame, and
active wall walks within the patient's pain tolerance. The patient will be asked to perform 2
sets of exercises once a day, at 10 repetitions per set.
STUDY VISITS AND PROCEDURES Study visits and related procedures are displayed in Table 1.
During the screening visit the study coordinator will obtain informed consent and perform
eligibility check, (which has been explained in recruitment section). Additional visits may
be required to address patient questions and to sign informed consent, collect demographics
(age, gender, race), medical history, clinical data. Qualified participants will be scheduled
for their combined appointment with anesthesiologist and chiropractor at the same time
(Baseline visit), and thereafter every week for 4-6 weeks depend on ROM achievement.
On the baseline visit, after routine documentation of the blood pressure, heart rate and
saturation of oxygen in room air and completion of baseline questionnaires, the patient would
move to the procedure room to receive the intervention that is described above.
Questionnaires will also be collected at each follow-up visits. Furthermore, the investigator
will perform the following procedures at all visits:
perform clinical examination,
report adverse events (AE) and/or serious adverse events (SAE), and
complete relevant section of case report form (CRF)