Subacromial Impingement SyndromeNCT01753271
Subacute Effects of Spinal Mobilization to Treat Subacromial Impingement
A study testing thoracic mobilization & shoulder mobilization & exercise and shoulder mobilization & exercise in people with Subacromial Impingement Syndrome, run by High Point University at 3 sites in United States.
Trial summary
Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- thoracic mobilization & shoulder mobilization & exercise and shoulder mobilization & exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Jun 2015
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side
Who cannot join
- Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Physical Therapy Services
Elizabethton, Tennessee, 37643
East Tennessee State University
Johnson City, Tennessee, 37604
About this study
Official title: Subacute Effects of Cervicothoracic Spinal Manipulation in Addition to Shoulder Manual Therapy Plus Exercise Intervention in Individuals With Subacromial Impingement Syndrome: a Randomized, Controlled Clinical Trial Pilot Study
Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement.
Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- thoracic mobilization & shoulder mobilization & exercise, shoulder mobilization & exercise
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic mobilization & shoulder mobilization & exerciseOther
shoulder mobilization & exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Thoracic Mobilization | Experimental | thoracic mobilization in addition to shoulder mobilization plus exercise Receives: Other: thoracic mobilization & shoulder mobilization & exercise; Other: shoulder mobilization & exercise |
| exercise only | Active comparator | shoulder mobilization plus exercise alone Receives: Other: shoulder mobilization & exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index Change over time
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Measured: 2 weeks, 4 weeks, discharge
Secondary outcomes (2)
Numeric Pain Rating Scale change over time
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Measured: 2 weeks, 4 weeks, discharge
Fear Avoidance Beliefs Questionnaire change over time
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
Measured: 2 weeks, 4 weeks, discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- High Point University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Walsh University
- Responsible party
- Sponsor
- Investigators
- Alexis A Wright, Phd, Principal investigator, High Point University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753271
- Sponsor's protocol ID
- 201208-122
- Status last verified
- Aug 2015
- First submitted
- 11 Dec 2012
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wright AA, Donaldson M, Wassinger CA, Emerson-Kavchak AJ. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study. J Man Manip Ther. 2017 Sep;25(4):190-200. doi: 10.1080/10669817.2016.1251377. Epub 2016 Nov 7.
PubMed 28912631
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacute Effects of Cervicothoracic Spinal Manipulation in Addition to Shoulder Manual Therapy Plus Exercise Intervention in Individuals With Subacromial Impingement Syndrome: a Randomized, Controlled Clinical Trial Pilot Study
- ClinicalTrials.gov ID
- NCT01753271
- Acronym / sponsor ID
- 201208-122
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- High Point UniversityUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Walsh University
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- First posted
- 20 Dec 2012 (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.
Specific Aims and Hypotheses Aims To investigate the incremental benefits of cervicothoracic spinal manipulation in addition to shoulder mobilization and exercise for improving range of motion, pain, physical function and fear avoidance beliefs in patients with subacromial shoulder impingement.
Hypotheses It is hypothesized that those subjects who receive spinal manipulation in addition to shoulder mobilization and exercise will achieve greater improvements in range of motion, pain, function and fear avoidance beliefs at two weeks following treatment conclusion, at 4 weeks following treatment conclusion, and at discharge when compared to the subjects who did not receive the spinal manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic Mobilization | Experimental | Other: thoracic mobilization & shoulder mobilization & exercise, Other: shoulder mobilization & exercisethoracic mobilization in addition to shoulder mobilization plus exercise |
| exercise only | Active comparator | Other: shoulder mobilization & exerciseshoulder mobilization plus exercise alone |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- To be eligible, participants must meet the clinical prediction rule for unilateral subacromial shoulder impingement including: a) positive Hawkins-Kennedy impingement sign, b) positive painful arc sign, and c) weakness in external rotation with the arm at the side
Key exclusion criteria (1 listed)
- Individuals with contraindications to treatment with mobilization and manipulation (Appendix A) will be excluded
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 |
|---|---|---|
| thoracic mobilization & shoulder mobilization & exercise | Other | Thoracic Mobilization |
| shoulder mobilization & exercise | Other | Thoracic Mobilization, exercise only |
Primary outcome
Shoulder Pain and Disability Index Change over time
Time frame: 2 weeks, 4 weeks, discharge
Patients will be followed for the duration of their physical therapy treatment. An average of 12 visits over 6 weeks
2 secondary outcomes
Numeric Pain Rating Scale change over time
Time frame: 2 weeks, 4 weeks, discharge
Fear Avoidance Beliefs Questionnaire change over time
Time frame: 2 weeks, 4 weeks, discharge
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 20 Aug 2015.
- Derived from this study: PubMed 28912631Wright AA, Donaldson M, Wassinger CA, Emerson-Kavchak AJ. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study. J Man Manip Ther. 2017 Sep;25(4):190-200. doi: 10.1080/10669817.2016.1251377. Epub 2016 Nov 7.
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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.
Alexis A Wright, Phd principal investigator
High Point University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic mobilization & shoulder mobilization & exercise and shoulder mobilization & exercise in people with Subacromial Impingement Syndrome, run by High Point University at 3 sites in United States.
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 1 inclusion and 1 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 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
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?
Shoulder Pain and Disability Index Change over time (time frame: 2 weeks, 4 weeks, discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01753271, which also lists 1 linked publication.
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 20 Aug 2015.