MobilityNCT02833779
Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome
A study testing Individual exercises and Group exercises in people with Mobility, run by Basque Health Service.
Trial summary
Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mobility
- What is being tested?
- Individual exercises and Group exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
- Self-perceived pain reported by the patient under clinical examination of the shoulder.
- A minimum of 90º mobility in flexion.
Who cannot join
- Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
- Patients were receiving other physiotherapy or rehabilitation treatments.
- Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.
About this study
Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology.
Objectives:
Read more
- Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
- Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice.
Patients will be assigned one of the following treatments:
- Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
- Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering.
A modified version of the Constant scale will be used to assess mobility and pain shoulder.
- Conditions
- Mobility
- Being tested
- Individual exercises, Group exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual exercisesOther
Group exercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Group Therapy Exercises | Active comparator | Patients will be taught exercises in groups of six persons, on a daily basis for twelve sessions. Receives: Other: Group exercises |
| Individual Manual Therapy Exercises | Active comparator | Patients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering Receives: Other: Individual exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of pain with a visual analogue scale.
Measured: Six Months
The mobility (joint range of motion) with a goniometer.
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startApr 2010
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MobilityStudies 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
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marcos Sanchez Garcia, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833779
- Sponsor's protocol ID
- SSD
- Status last verified
- Jul 2016
- First submitted
- 5 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Compare the Effectiveness of Group Versus Individual Therapy on Alternate Days in Patients With Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02833779
- Acronym / sponsor ID
- SSD
- Conditions
- Mobility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Apr 2010
- Primary completion
- Oct 2013 (actual)
- First posted
- 14 Jul 2016 (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.
Pathology of the rotator cuff and subacromial bursa is considered to be the principal cause of pain and symptoms arising from the shoulder. Physiotherapy specialists often disagree about which type of exercise is most appropriate. Manual Physiotherapy combined with guided exercise is a commonly applied clinical treatment, but no proof of its effectiveness has been shown. Clinical trials comparing results of treating subacromial syndrome of the shoulder with guided self-treatment and conventional physiotherapy yielded a slightly higher improvement, basically because patients suffered from chronic tendinitis and the treatment period lasted only two weeks. That is the reason why the investigators propose a long-term follow-up study and a more complete assessment of effectiveness of the exercise prescribed to improved this pathology.
Objectives:
- Assessment of effectiveness of two different types of treatment of subacromial syndrome of the shoulder.
- Comparison of effectiveness of both treatments in order to select that one yielding better results as the one to be applied as a routine practice.
Patients will be assigned one of the following treatments:
- Group 1: patients will be taught exercises in groups of six people, on a daily basis for twelve sessions.
- Group 2: patients will be taught the same exercise as Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering.
A modified version of the Constant scale will be used to assess mobility and pain shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Therapy Exercises | Active comparator | Other: Group exercisesPatients will be taught exercises in groups of six persons, on a daily basis for twelve sessions. |
| Individual Manual Therapy Exercises | Active comparator | Other: Individual exercisesPatients will be taught the same exercises as in a Group 1, individually, and will receive manual therapy consisting of muscular and joint re-centering |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- History of shoulder pain defined as at least 2 positive results in subacromial impingement tests.
- Self-perceived pain reported by the patient under clinical examination of the shoulder.
- A minimum of 90º mobility in flexion.
Key exclusion criteria (3 listed)
- Luxation, a history of surgery, or evidence the current shoulder pain or other symptoms under cervical examination or other shoulder bone disease, except for acromioclavicular joint arthrosis.
- Patients were receiving other physiotherapy or rehabilitation treatments.
- Patients had been treated for SIS (subacromial impingement syndrome) with injection of anti-inflammatory or analgesic drugs in the last month.
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 |
|---|---|---|
| Individual exercises | Other | Individual Manual Therapy Exercises |
| Group exercises | Other | Group Therapy Exercises |
Primary outcome
The assessment of pain with a visual analogue scale.
Time frame: Six Months
The mobility (joint range of motion) with a goniometer.
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individual exercises and Group exercises in people with Mobility, run by Basque Health Service.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of pain with a visual analogue scale. (time frame: Six Months). The study lists 2 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 15 Jul 2016.