TendinopathyNCT02304003
The Effect of an Evidence-based Physiotherapy Regimen for Patients With Rotator Cuff Tendinopathy
A study testing Structured Physiotherapy Regimen in people with Tendinopathy and Shoulder Impingement Syndrome, run by Bergen University College at 1 site in Norway.
Trial summary
Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tendinopathy, Shoulder Impingement Syndrome, Shoulder Pain
- What is being tested?
- Structured Physiotherapy Regimen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2014to Jun 2022
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
- Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
- Symptom duration of minimum 3 months.
- Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
- Positive isometric abduction and/or lateral rotation (Ombregt, Bisschop \& Veer, 2003)
- Painful arc during active abduction (Ombregt, Bisschop \& Veer, 2003)
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- Positive Neers sign (Neer, 1972 ; Tennent, Beach \& Meyers, 2003)
- Positive Jobes test (Jobe \& Moynes, 1982 ; Tennent, Beach \& Meyers, 2003)
- Positive Hawkins-Kennedy impingement test (Hawkins \& Kennedy, 1980)
Who cannot join
- Shoulder pain due to trauma, e.g. fall.
- Reduced ROM consistent with adhesive capsulitis/frozen shoulder
- History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
- Full thickness rupture of rotator cuff tendon
- OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
- Subjects with other comorbidity: Rheumatological or neurological disease, fibromyalgia or symptoms from the cervical spine
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- Subjects suffering from serious psychiatric illness.
- Subjects unable to understand English or Norwegian.
- Less than 3 positive reproducible sings of rotator cuff pathology / subacromial disease.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Department of Physiotherapy, Hillevaag General Practitioner Practice
Stavanger, 4016
Sturla Haslerud, Msc, 93424347 ext. 0047, shas@hib.no
Jon Joensen, PhD, 55 58 72 31 ext. 0047, jon.joensen@hib.no
About this study
Official title: The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.
Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.
Read the detailed description
There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.
- Being tested
- Structured Physiotherapy Regimen, Standard Care
- Keywords
- Shoulder tendinopathy, Subacromial impingement syndrome, Rotator cuff tendinopathy, Supraspinatus tendinopathy
- Medical subject headings
- Tendinopathy, Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Physiotherapy RegimenOther
Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.
Standard CareOther
Standard follow up in primary care.
| Study group | Role | What they receive |
|---|---|---|
| Structured Physiotherapy regimen | Experimental | Heavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy Receives: Other: Structured Physiotherapy Regimen |
| Standard care | Other | Standard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgery
Dichotomised questionnaire yes or no
Measured: 12 weeks (end of treatment) and 6 months post treatment
Shoulder function
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Measured: 4 weeks , 12 weeks and 6 months
Shoulder Pain
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Measured: 4 weeks , 12 weeks and 6 months
Generic health status
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
Measured: 12 weeks and 6 months
Secondary outcomes (5)
Rotator cuff force
Maximal painfree isometric force measurements of rotator cuff muscles using handheld dynamometry .
Measured: 12 weeks ( end of treatment)
Tendon pain pressure threshold
Tendon pressure applied over individual rotator cuff tendons with analogue algometer. Pain threshold registered in kilograms.
Measured: 12 weeks ( end of treatment )
Analgesics and corticosteroid injections
Analgesics consumption and corticosteroids injections registered on questionaire.
Measured: 4 weeks , 12 weeks and 6 months
Tendon thickness
Ultrasonography measurements of rotator cuff tendon thickness ( subscapularis , supraspinatus , infraspinatus , biceps )
Measured: 12 weeks ( end of treatment )
Patient global impression of change
To assess global improvement a 7 point categorical scale ranging from " much better to much worse" is used.
Measured: 4 weeks, 12 weeks & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bergen University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Principal investigator, Sturla Haslerud, Bergen University College
- Investigators
- Jan Magnus Bjordal, Professor, Study chair, University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304003
- Sponsor's protocol ID
- BergenUC
- Other IDs
- 2012/2134
- Status last verified
- Aug 2018
- First submitted
- 26 Nov 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Evidence-based Physiotherapy Regimen for Patients on Need for Subacromial Decompression Surgery Due to Rotator Cuff Tendinopathy : a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02304003
- Acronym / sponsor ID
- BergenUC
- Keywords
- Shoulder tendinopathy, Subacromial impingement syndrome, Rotator cuff tendinopathy, Supraspinatus tendinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bergen University CollegeUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Apr 2014 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Primary aim of this study is to investigate wether an evidence-based physiotherapy regimen is more effective than standard care in patients referred for arthroscopic surgery of the shoulder. It is hypothesized that a multimodal physiotherapy regimen will relieve pain, improve shoulder function and reduce the need for subacromial decompression surgery of the shoulder compared to standard care/wait and see controls.
Detailed description
There has been a fourfold increase in surgery rates for non-traumatic shoulder disorders , despite increasing evidence demonstrating that there is no difference in effect between physiotherapy based- and surgical interventions. The target population for this study is patients suffering from rotator cuff tendinopathy waiting for subacromial decompression surgery at a university hospital in Norway. During this waiting period , study participants will be randomly assigned to standard follow up or a physiotherapy regimen in primary care. We want to compare the effect of a structured physiotherapy regimen consisting of heavy slow resistance exercises, stretching, manual mobilization and low level laser therapy to standard follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Physiotherapy regimen | Experimental | Other: Structured Physiotherapy RegimenHeavy-slow resistance training of rotator cuff . Scapular exercises. Manual mobilisation of glenohumeral joint . Stretching. Low Level Laser therapy |
| Standard care | Other | Other: Standard CareStandard care offered in primary care while waiting for surgery , this may be but are not limited to : Wait and see, Drugs ( NSAIDS ), Corticosteroid injections, physiotherapy or other conservative treatment options. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients on need for surgery ( placed at surgical waiting list at hospital or referred to surgery by their GP )
- Typical history with difficulties working with arms elevated over the head, and pain located in the upper segment of C5 dermatome.
- Symptom duration of minimum 3 months.
- Three or more reproducible signs of rotator cuff tendinopathy / subacromial impingement:
Key exclusion criteria (9 listed)
- Shoulder pain due to trauma, e.g. fall.
- Reduced ROM consistent with adhesive capsulitis/frozen shoulder
- History in combination with examination and tests (apprehension/relocation), giving reason to suspect pathological instability
- Full thickness rupture of rotator cuff tendon
- OA of the glenohumeral joint, Os acromiale with decreased space of the subacromial space, previous fractures in the shoulder complex or shoulder surgery on the symptomatic side.
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 |
|---|---|---|
| Structured Physiotherapy RegimenExperimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week. | Other | Structured Physiotherapy regimen |
| Standard CareStandard follow up in primary care. | Other | Standard care |
Primary outcome
Need for surgery
Time frame: 12 weeks (end of treatment) and 6 months post treatment
Dichotomised questionnaire yes or no
Shoulder function
Time frame: 4 weeks , 12 weeks and 6 months
Shoulder Pain and Disability Index. 13 questions. To answer the questions, patients place a mark on a 10 point numerical scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult it required help'.
Shoulder Pain
Time frame: 4 weeks , 12 weeks and 6 months
Night pain assessed on a 10 point numerical scale . Pain now and this week measured on a 10 point numerical scale .
Generic health status
Time frame: 12 weeks and 6 months
EQ-5D questionaire. The system comprises the following 5 dimensions: mobility, self-care, usual activities,pain and anxiety/depression. he respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions.
5 secondary outcomes
Rotator cuff force
Time frame: 12 weeks ( end of treatment)
Tendon pain pressure threshold
Time frame: 12 weeks ( end of treatment )
Analgesics and corticosteroid injections
Time frame: 4 weeks , 12 weeks and 6 months
Tendon thickness
Time frame: 12 weeks ( end of treatment )
Patient global impression of change
Time frame: 4 weeks, 12 weeks & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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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.
Jan Magnus Bjordal, Professor study chair
University of Bergen , Dep. of Global Public Health and Primary Care, Physiotherapy Research Group, Norway.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Physiotherapy Regimen in people with Tendinopathy and Shoulder Impingement Syndrome, run by Bergen University College at 1 site in Norway.
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 9 inclusion and 9 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 23 Aug 2018. 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 Norway. 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 Jan Magnus Bjordal, Professor (55 58 60 37 ext. 0047, Jan.Bjordal@igs.uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for surgery (time frame: 12 weeks (end of treatment) and 6 months post treatment). The study lists 4 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 23 Aug 2018.