Shoulder Impingement SyndromeNCT02172079
Mobilization With Movement for Shoulder Impingement
A study testing Real mobilization-with-movement (MWM) in people with Shoulder Impingement Syndrome, run by César Fernández-de-las-Peñas at 1 site in Spain.
Trial summary
Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Real mobilization-with-movement (MWM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jan 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of shoulder pain of > 3months duration
- pain localized at the proximal anterolateral shoulder region
- medical diagnosis of shoulder impingement syndrome
- at least 2 positive impingement tests including Neer, Hawking, or Jobe test
Who cannot join
- diagnosis of fibromyalgia
- pregnancy
- a history of traumatic onset of shoulder pain
- other histories of shoulder injury
- ligamentous laxity based on a positive Sulcus test and apprehension test
- numbness or tingling in the upper extremity
Show all 9Show fewer
- previous shoulder or cervical spine surgery
- corticosteroid injection on the shoulder within 1 year of the study
- physical therapy 6 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mobilization-with-Movement on Pain and Range of Motion in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial
Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Real mobilization-with-movement (MWM), Sham mobilization-with-movement (MWM)
- Keywords
- shoulder impingement, manual therapy, pain, motion.
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real mobilization-with-movement (MWM)Other
Sham mobilization-with-movement (MWM)Other
| Study group | Role | What they receive |
|---|---|---|
| Real mobilization-with-movement (MWM) | Experimental | For the MWM group, an accessory posterior-lateral gliding movement in the humeral head combined with a movement of active shoulder flexion will be applied. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior aspect of the head of the humerus Receives: Other: Real mobilization-with-movement (MWM) |
| Sham mobilization-with-movement (MWM) | Sham comparator | The sham condition will replicate the treatment condition except for the hand positioning. The therapist locates one hand over the belly of the pectoralis major muscle and the other over scapula without applying any pressure. The patient will be asked to move the arm in a similar manner as in the MWM group Receives: Other: Sham mobilization-with-movement (MWM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the intensity of shoulder pain before and after the treatment
Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion.
Measured: Baseline and one week after intervention
Secondary outcomes (1)
Changes in shoulder range of motion before and after the treatment
A universal goniometer was used to assess the participant's shoulder range of motion in the following motions:
- Pain-free and maximum (painful) range of motion in shoulder flexion
- Pain-free range of motion in shoulder extension
- Pain-free range of motion in shoulder abduction
- Pain-free range of motion in shoulder external rotation
- Pain-free range of motion in shoulder medial (internal) rotation
Measured: Baseline and one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- César Fernández-de-las-Peñas
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Sponsor-investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- Francisco Alburquerque Sendín, PT, PhD, Principal investigator, University of SalamancaCésar Fernández de las Peñas, PT, PhD, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172079
- Sponsor's protocol ID
- USAL201000048540
- Status last verified
- Jun 2014
- First submitted
- 22 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobilization-with-Movement on Pain and Range of Motion in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02172079
- Acronym / sponsor ID
- USAL201000048540
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder impingement, manual therapy, pain, motion.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- César Fernández-de-las-PeñasUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jun 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.
Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome. However, no adequately powered clinical trials have examined the effects of mobilization-with-movement. The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real mobilization-with-movement (MWM) | Experimental | Other: Real mobilization-with-movement (MWM)For the MWM group, an accessory posterior-lateral gliding movement in the humeral head combined with a movement of active shoulder flexion will be applied. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior aspect of the head of the humerus |
| Sham mobilization-with-movement (MWM) | Sham comparator | Other: Sham mobilization-with-movement (MWM)The sham condition will replicate the treatment condition except for the hand positioning. The therapist locates one hand over the belly of the pectoralis major muscle and the other over scapula without applying any pressure. The patient will be asked to move the arm in a similar manner as in the MWM group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of shoulder pain of > 3months duration
- pain localized at the proximal anterolateral shoulder region
- medical diagnosis of shoulder impingement syndrome
- at least 2 positive impingement tests including Neer, Hawking, or Jobe test
Key exclusion criteria (9 listed)
- diagnosis of fibromyalgia
- pregnancy
- a history of traumatic onset of shoulder pain
- other histories of shoulder injury
- ligamentous laxity based on a positive Sulcus test and apprehension test
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 |
|---|---|---|
| Real mobilization-with-movement (MWM) | Other | Real mobilization-with-movement (MWM) |
| Sham mobilization-with-movement (MWM) | Other | Sham mobilization-with-movement (MWM) |
Primary outcome
Changes in the intensity of shoulder pain before and after the treatment
Time frame: Baseline and one week after intervention
Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion.
1 secondary outcome
Changes in shoulder range of motion before and after the treatment
Time frame: Baseline and one week after the intervention
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 24 Jun 2014.
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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.
Francisco Alburquerque Sendín, PT, PhD principal investigator
University of Salamanca
César Fernández de las Peñas, PT, PhD study chair
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real mobilization-with-movement (MWM) in people with Shoulder Impingement Syndrome, run by César Fernández-de-las-Peñas at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 24 Jun 2014. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Changes in the intensity of shoulder pain before and after the treatment (time frame: Baseline and one week after intervention). 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 24 Jun 2014.