Adhesive CapsulitisNCT03245476
Education-based Physical Therapy Approach for Adhesive Capsulitis
A study testing Physical therapy focus on manual therapy and home-exercises and Physical therapy focus on education and supported home exercises in people with Adhesive Capsulitis, run by Hasselt University at 1 site in Belgium.
Trial summary
This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Physical therapy focus on manual therapy and home-exercises and Physical therapy focus on education and supported home exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Sep 2017to 4 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 % loss of passive GH external rotation motion, together with motion losses greater than 25% in at least two other GH movements, as compared to the unaffected side
- the pain accompanying the motion losses has to be present for at least one month. During that month, the pain and mobility deficits have to be stable or get worse
Who cannot join
- bilateral frozen shoulder
- systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand
Trial locations and contacts
1 site in 1 country.
Annick Timmermans, prof. dr. contact
Belgium1 site
Jessa Ziekenhuis
Hasselt, 3500
Liesbet De Baets, dr., +32 11 29 21 29, liesbet.debaets@uhasselt.be
Carl Dierickx, carl.dierickx@jessazh.be
About this study
Official title: Physiotherapy in Adhesive Capsulitis Pathology: Effect of an Education Based Approach on Arthroscopic Evaluation Results, Joint Range of Motion, Psychosocial Factors, Shoulder Pain and Arm Function
This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically relevant outcomes (range of glenohumeral motion, psychological factors, pain, shoulder function, quality of life) and on parameters derived from arthroscopic glenohumeral investigation by means of MRI.
Furthermore, associations between (1) the results on the MRI investigation, (2) the range of glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be assessed at different time-points (before and at 6-12-18 and 52 weeks after the first injection).
- Conditions
- Adhesive Capsulitis
- Being tested
- Physical therapy focus on manual therapy and home-exercises, Physical therapy focus on education and supported home exercises
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy focus on manual therapy and home-exercisesOther
corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
Physical therapy focus on education and supported home exercisesOther
corticosteroid injection + physiotherapy with focus on education and supported home exercises
| Study group | Role | What they receive |
|---|---|---|
| manual therapy and home-exercises | Active comparator | corticoid injection + physiotherapy with a focus on manual therapy and home-exercises Receives: Other: Physical therapy focus on manual therapy and home-exercises |
| education and supported home exercises | Active comparator | corticosteroid injection + physiotherapy with focus on education and supported home exercises Receives: Other: Physical therapy focus on education and supported home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapulothoracic, glenohumeral and elbow joint range of motion
before the first injection with corticosteroids By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Measured: baseline
Scapulothoracic, glenohumeral and elbow joint range of motion
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Measured: week 6
Scapulothoracic, glenohumeral and elbow joint range of motion
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Measured: week 12
Scapulothoracic, glenohumeral and elbow joint range of motion
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Measured: week 18
Scapulothoracic, glenohumeral and elbow joint range of motion
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Measured: week 52
parameters on arthrographic investigation by means of MRI
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Measured: baseline
parameters on arthrographic investigation by means of MRI
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Measured: week 18
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Measured: baseline
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Measured: week 6
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Measured: week 12
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Measured: week 18
Disability of the shoulder, elbow and hand questionnaire
assessment of upper limb function
Measured: week 52
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Measured: baseline
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Measured: week 6
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Measured: week 12
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Measured: week 18
Brief pain inventory
assessment of current, worst and night pain on a 11 point likert scale
Measured: week 52
Secondary outcomes (20)
EQ-5D-5L questionnaire
Quality of life assessment
Measured: baseline
EQ-5D-5L questionnaire
Quality of life assessment
Measured: week 6
EQ-5D-5L questionnaire
Quality of life assessment
Measured: week 12
EQ-5D-5L questionnaire
Quality of life assessment
Measured: week 18
EQ-5D-5L questionnaire
Quality of life assessment
Measured: week 52
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Measured: baseline
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Measured: week 6
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Measured: week 12
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Measured: week 18
Self-efficacy questionnaire
this questionnaire assesses the self-efficacy of a person
Measured: week 52
Tampa scale of kinesiophobia
this scale investigates fear of movement
Measured: baseline
Tampa scale of kinesiophobia
this scale investigates fear of movement
Measured: week 6
Tampa scale of kinesiophobia
this scale investigates fear of movement
Measured: week 12
Tampa scale of kinesiophobia
this scale investigates fear of movement
Measured: week 18
Tampa scale of kinesiophobia
this scale investigates fear of movement
Measured: week 52
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Measured: baseline
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Measured: week 6
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Measured: week 12
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Measured: week 18
Hospital anxiety and depression scale
this scale investigates anxiety and depression
Measured: week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start4 Sep 2017 (estimated)
- Primary completion4 Sep 2019 (estimated)
- Study completion4 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Liesbet De Baets, dr., Study chair, Hasselt UniversityAnnick Timmermans, prof. dr., Principal investigator, Hasselt UniversityCarl Dierickx, prof. dr., Study chair, Jessa ziekenhuis, Universiteit Hasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245476
- Sponsor's protocol ID
- 17.08/REVA17.01
- Status last verified
- Aug 2017
- First submitted
- 8 Aug 2017
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy in Adhesive Capsulitis Pathology: Effect of an Education Based Approach on Arthroscopic Evaluation Results, Joint Range of Motion, Psychosocial Factors, Shoulder Pain and Arm Function
- ClinicalTrials.gov ID
- NCT03245476
- Acronym / sponsor ID
- 17.08/REVA17.01
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital
- Study start
- 4 Sep 2017 (estimated)
- Primary completion
- 4 Sep 2019 (estimated)
- Study completion
- 4 Sep 2019 (estimated)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims, by means of a randomized control trial, to investigate which treatment method (corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises) gives better results on clinically relevant outcomes (range of glenohumeral motion, psychological factors, pain, shoulder function, quality of life) and on parameters derived from arthroscopic glenohumeral investigation by means of MRI.
Furthermore, associations between (1) the results on the MRI investigation, (2) the range of glenohumeral motion, (3) shoulder function and pain, and (4) psychological factors will be assessed at different time-points (before and at 6-12-18 and 52 weeks after the first injection).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- corticoid injection + physiotherapy with a focus on manual therapy and home-exercises versus corticosteroid injection + physiotherapy with focus on education and supported home exercises
| Arm | Type | Receives |
|---|---|---|
| manual therapy and home-exercises | Active comparator | Other: Physical therapy focus on manual therapy and home-exercisescorticoid injection + physiotherapy with a focus on manual therapy and home-exercises |
| education and supported home exercises | Active comparator | Other: Physical therapy focus on education and supported home exercisescorticosteroid injection + physiotherapy with focus on education and supported home exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 % loss of passive GH external rotation motion, together with motion losses greater than 25% in at least two other GH movements, as compared to the unaffected side
- the pain accompanying the motion losses has to be present for at least one month. During that month, the pain and mobility deficits have to be stable or get worse
Key exclusion criteria (2 listed)
- bilateral frozen shoulder
- systemic and/or neurologic disease or a self-reported pathologic condition of the cervical/thoracic region, elbow or wrist/hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy focus on manual therapy and home-exercisescorticoid injection + physiotherapy with a focus on manual therapy and home-exercises | Other | manual therapy and home-exercises |
| Physical therapy focus on education and supported home exercisescorticosteroid injection + physiotherapy with focus on education and supported home exercises | Other | education and supported home exercises |
Primary outcome
Scapulothoracic, glenohumeral and elbow joint range of motion
Time frame: baseline
before the first injection with corticosteroids By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Scapulothoracic, glenohumeral and elbow joint range of motion
Time frame: week 6
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Scapulothoracic, glenohumeral and elbow joint range of motion
Time frame: week 12
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Scapulothoracic, glenohumeral and elbow joint range of motion
Time frame: week 18
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
Scapulothoracic, glenohumeral and elbow joint range of motion
Time frame: week 52
after the first injection with corticosteroids. By means of inertial motion sensors, range of motion in the scapulothoracic, glenohumeral and elbow joint will be assessed during functional task performance
parameters on arthrographic investigation by means of MRI
Time frame: baseline
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
parameters on arthrographic investigation by means of MRI
Time frame: week 18
the thickness of the coracohumeral ligament, the capacity of the inferior glenohumeral joint recessus are investigated.
Disability of the shoulder, elbow and hand questionnaire
Time frame: baseline
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
Time frame: week 6
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
Time frame: week 12
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
Time frame: week 18
assessment of upper limb function
Disability of the shoulder, elbow and hand questionnaire
Time frame: week 52
assessment of upper limb function
Brief pain inventory
Time frame: baseline
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
Time frame: week 6
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
Time frame: week 12
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
Time frame: week 18
assessment of current, worst and night pain on a 11 point likert scale
Brief pain inventory
Time frame: week 52
assessment of current, worst and night pain on a 11 point likert scale
20 secondary outcomes
EQ-5D-5L questionnaire
Time frame: baseline
EQ-5D-5L questionnaire
Time frame: week 6
EQ-5D-5L questionnaire
Time frame: week 12
EQ-5D-5L questionnaire
Time frame: week 18
EQ-5D-5L questionnaire
Time frame: week 52
Self-efficacy questionnaire
Time frame: baseline
Self-efficacy questionnaire
Time frame: week 6
Self-efficacy questionnaire
Time frame: week 12
Self-efficacy questionnaire
Time frame: week 18
Self-efficacy questionnaire
Time frame: week 52
Tampa scale of kinesiophobia
Time frame: baseline
Tampa scale of kinesiophobia
Time frame: week 6
Tampa scale of kinesiophobia
Time frame: week 12
Tampa scale of kinesiophobia
Time frame: week 18
Tampa scale of kinesiophobia
Time frame: week 52
Hospital anxiety and depression scale
Time frame: baseline
Hospital anxiety and depression scale
Time frame: week 6
Hospital anxiety and depression scale
Time frame: week 12
Hospital anxiety and depression scale
Time frame: week 18
Hospital anxiety and depression scale
Time frame: week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annick Timmermans, prof. dr. contact
Liesbet De Baets, dr. study chair
Hasselt University
Annick Timmermans, prof. dr. principal investigator
Hasselt University
Carl Dierickx, prof. dr. study chair
Jessa ziekenhuis, Universiteit Hasselt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy focus on manual therapy and home-exercises and Physical therapy focus on education and supported home exercises in people with Adhesive Capsulitis, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liesbet De Baets, dr. (+32 11 29 21 29, liesbet.debaets@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scapulothoracic, glenohumeral and elbow joint range of motion (time frame: baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.