Frozen Shoulder Treatment With Intra-Articular Corticosteroid Injection and Suprascapular Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversitair Ziekenhuis Brussel
About this trial
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life.
The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, double blinded randomized clinical trials using a combination of SSNB and IACI are rare.
The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis.
As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure
Suffering from Frozen Shoulder, defined as: Frozen shoulder is a self-limiting disease characterized by pain and functional restriction in both active and passive shoulder motion lasting more than 1 month, for which radiographic findings of the shoulder joint are unremarkable.
Dutch or French speaking persons
Age ≥ 18 years
Disqualifiers
Subjects with posttraumatic or postsurgical stiff shoulder syndrome
History of trauma at the onset of symptoms
Subjects with rheumatologic or neurologic disease involving the shoulder
Subjects with cervical radiculopathy
Trial design
Design model
Parallel
Treatments tested in this trial
SSNB + IACI
Other interventionUsual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM
Sham SSNB + IACI
Other interventionUsual care: All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria but is the physiotherapist's choice how to implement these guidelines in clinical practice. Patient education on home-exercises Monitoring of peak pain, at rest/night and after rehabilitation sessions using a Numeric-Pain-Rating-Scale (0-10) (NPRS) to evaluate tissue irritability and guide physiotherapy and rehabilitation. Use of passive physiotherapy (cold, heat or electric therapies) to treat pain. Active and passive mobilization of the shoulder under the pain threshold, Maitland mobilization, stretch exercises such as: table slides, wall climbers. Use of affected upper limb in pain free Range-of-Motion (ROM) is tolerated and stimulated. Progressively increase time and frequency of Total-End-Range-Time (TERT) positions to increase ROM
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: SSNB + IACIActive comparator 1 intervention
Group B: Short-acting SSNB + IACIPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
Time frame
3 monthsSecondary outcomes
1
Pain - Numeric Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). It is the simplest and most commonly used pain rating scale and offers numerous advantages, including ease of administration and scoring, multiple response options, and no reported age-related difficulties in its use.
Time frame
4 weeks - 3 months - 6 months - 12months after the intervention2
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
Time frame
4 weeks- 6 months - 12months after the intervention3
Constant- Murley score (CMS)
The CMS is a composite scale divided into four sections: pain (15 points), activities of daily living (20 points), ROM (40 points) and strength (25 points) with a total score ranging from 0 (worst possible) to 100 (best possible). Patients were asked to verbally rate each parameter.
Time frame
4weeks - 3 months - 6 months - 12 months after the intervention4
Health related quality of life, evaluated with the EuroQol
The EQ-5D 3L is a generic measure of health-related quality of life developed by the EuroQol Group. It is a validated measurement of quality of life widely used in different pathologies. The questionnaire is made up of two parts. The first part is descriptive and uses five different dimensions to score quality of life. These five dimensions are mobility, self-care, activities of the daily life, pain/discomfort and anxiety/depression. There are five different answer possibilities within each dimension, i.e. "no problem", "slight problem", "moderate problem", "severe problem" and "unable to". This renders 3125 different answer possibilities. The second part uses a visual analogue scale (VAS) to score the current health status of the patient, ranging from zero to one hundred. Zero corresponds to death and one hundred corresponds to a (subjective) perfect health status.
Time frame
4weeks - 3 months - 6 months - 12 months after the interventionOther outcomes
1
Superiority analysis of shoulder-related disability, pain and shoulder stiffness at 6 months after start of enrolment.
An intermediary statistical analysis will be performed at 6 months after start of enrolment. In case all 3 outcomes (disability, pain, shoulder stiffness) show non-superiority at 6m, the study will not be extended to the 12-month time point.
Time frame
6 months after start of enrolment2
Exploratory prediction analysis: part 1
Through regression analysis the investigators want to find out which factors predict I) SPADI score at 3 -6- 12 months follow-up, II) pain NPR level at 3-6-12 months, III) shoulder ROM (°) at 3-6-12 months and IV) return to work and WAI score at 3-6-12 months. The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame
18 months after inclusion3
Exploratory prediction analysis: part 2
Through regression analysis the investigators want to identify which physical examination tests, or which combinations of tests are correlated with MRI diagnostic criteria and a more positive evolution of SPADI score - NPR pain score - shoulder ROM (°)- Return to Work (RTW)/WAI score: The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame
18 months after inclusion4
Exploratory prediction analysis: part 3
Through regression analysis the investigators want to identify patients that benefit the most from the combined SSNB + IACI The initial set of predictor variables, baseline values, that will be considered is : 1. SPADI score 2. Presence of joint capsule enhancement on MRI: (yes/no) 3. Shoulder ROM (°) 4. Age (years) 5. Gender (male/female) 5\. Duration of symptoms to intervention (weeks) 6. Presence of diabetes (yes/no)
Time frame
18 months after inclusionSponsors and contacts
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Source ClinicalTrials.gov