Adhesive Capsulitis
Conditions
Keywords
Injections, Intra-Articular, Range of Motion, Articular, Pain
Brief summary
The purpose of the study is to compare the efficacy of intra-articular hydraulic distension (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and capsule-preserving IHDs.
Detailed description
The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure within the joint space. Although IHD is one of the most common treatment options for the PSS, the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid rupture, thus producing less satisfactory outcomes. However, we devised in our previous study a novel technique that enabled a physician to infuse the possible largest volume without rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.
Interventions
PROCEDURECapsule-Preserving Intra-articular Hydraulic Distension
Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
PROCEDURECapsule-Rupturing Intra-articular Hydraulic Distension
Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* shoulder discomfort for at least one month * limited range of motion of the glenohumeral joint in at least two directions
Exclusion criteria
* systemic inflammatory joint disease * radiological evidence of bony abnormality of the shoulder * full-thickness rotator cuff tear * acute systemic medical illness * history of major trauma or surgery involving the shoulder * contraindication to intra-articular, local anesthestic injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion (ROM) of the Glenohumeral Joint | 1 month | 1. before intervention for all participants 2. using a goniometer 3. patient sitting on a stool with the arm at anatomical position 4. worst: 0 degree 5. best: 360 degree |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured by Visual Analogue Scale (VAS) | 1 month | 1. before intervention for all participants 2. using 10cm horizontal visual analog scale 3. best: 0cm (no pain) 4. worst: 10cm (worst pain) |
Countries
South Korea
Participant flow
Recruitment details
Recruitment Dates: from Mar 2008 until Oct 2009 Type of Location: outpatient clinic at a university hospital Method of Recruitment: informed consent from eligible patients
Pre-assignment details
Participants with other diagnoses than the painful stiff shoulder, such as full-thickness rotator cuff tear, osteoarthritis and others, were excluded from the trial when the final diagnosis was determined.
Participants by arm
| Arm | Count |
|---|---|
| CPIHD Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule. | 32 |
| CRIHD Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed. | 22 |
| Total | 54 |
Baseline characteristics
| Characteristic | CPIHD | CRIHD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 4 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 18 Participants | 39 Participants |
| Age Continuous | 61.09 years STANDARD_DEVIATION 10.621 | 56.55 years STANDARD_DEVIATION 9.521 | 59.24 years STANDARD_DEVIATION 10.343 |
| Pain Measured by Visual Analogue Scale (VAS) | 6.87 cm STANDARD_DEVIATION 3.01 | 7.17 cm STANDARD_DEVIATION 2.09 | 6.99 cm STANDARD_DEVIATION 2.65 |
| Range of Motion (ROM) of the Glenohumeral Joint | 223.56 degree STANDARD_DEVIATION 42.111 | 203.05 degree STANDARD_DEVIATION 46.163 | 215.20 degree STANDARD_DEVIATION 44.555 |
| Region of Enrollment Korea, Republic of | 32 participants | 22 participants | 54 participants |
| Sex: Female, Male Female | 21 Participants | 16 Participants | 37 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 22 |
| serious Total, serious adverse events | 0 / 32 | 0 / 22 |
Outcome results
Primary
Range of Motion (ROM) of the Glenohumeral Joint
1. before intervention for all participants 2. using a goniometer 3. patient sitting on a stool with the arm at anatomical position 4. worst: 0 degree 5. best: 360 degree
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPIHD | Range of Motion (ROM) of the Glenohumeral Joint | 261.95 degree | Standard Deviation 47.197 |
| CRIHD | Range of Motion (ROM) of the Glenohumeral Joint | 241.84 degree | Standard Deviation 57.304 |
Secondary
Pain Measured by Visual Analogue Scale (VAS)
1. before intervention for all participants 2. using 10cm horizontal visual analog scale 3. best: 0cm (no pain) 4. worst: 10cm (worst pain)
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CPIHD | Pain Measured by Visual Analogue Scale (VAS) | 2.96 cm | Standard Deviation 2.89 |
| CRIHD | Pain Measured by Visual Analogue Scale (VAS) | 5.03 cm | Standard Deviation 2.95 |