Clinical trial NCT04687735: Frozen Shoulder Single Arm Prospective Study
Official title: Minimally Invasive Technique to Increase the Range of Motion of the Shoulder Joint in Frozen Shoulder: Single Arm Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frozen Shoulder
Keywords: Brachial Plexus Block
Physical Therapy
Quality of Life
Lead sponsor: Allevio Pain Management Clinic
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single-center, prospective cohort study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of combination of brachial plexus block plus physical therapy on quality of life improvement in patients with frozen shoulder condition via standard questionnaires.

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Diagnosis of unilateral or bilateral frozen shoulder, defined as greater than 50% limitation of passive ROM relative to the non affected side in one or more of three movement directions (i.e., abduction in the frontal plane, forward flexion in the sagittal plane, or external rotation in 0° of abduction) with a hard end feel
* Symptoms of frozen shoulder that had lasted for at least 3 months.
* Willing and able to provide informed consent and perform home-based exercises as instructed.
* Willing and able to complete study questionnaires

Exclusion Criteria:

* Previous manipulation of the affected shoulder under anesthesia in the last year;
* Other rheumatic conditions involving the shoulder (e.g., rheumatoid arthritis, ankylosing Spondylitis,
* Fracture or dislocation of the affected shoulder;
* Previous shoulder surgery;
* Hill-Sachs lesion, severe osteoporosis, or malignancies in the shoulder region);
* Neurologic deficits affecting shoulder function;
* History of allergy to lidocaine;
* Corticosteroid injection in the affected shoulder during the receding 4 weeks.
* Non-English speakers;
* Active non- controlled mental disorders
* Multiple complete tear in ligaments of rotator cuff
* Any infection including COVID-19

Primary outcomes:
measure: changes in disability score
timeFrame: 12 months
measure: changes in disability score
timeFrame: 12 months
Secondary outcomes:
measure: Changes in pain score (If there is any pain)
timeFrame: 12 months
measure: Changes in anxiety score
timeFrame: 12 months
measure: Changes in depression score
timeFrame: 12 months
measure: Changes in treatment satisfaction
timeFrame: 12 months
measure: Frequency and duration of treatment related side
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Allevio Pain Management
state: Ontario
Study officials:
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