Shoulder Pain ChronicNCT03088085
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
A study testing Self-mobilization and Sleep Education in people with Shoulder Pain Chronic, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to UTSW physicians with shoulder pain. The investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Shoulder Pain Chronic
- What is being tested?
- Self-mobilization and Sleep Education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 1 May 2020
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder pain with associated sleeping disturbance
- Between the ages of 18-89
- Present to the clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery at UTSW
Who cannot join
- non-English speakers
- chronic pain or rheumatic disorders
- unstable psychopathology, cognitive impairment (including dementia)
- current or recent history (within 6 months) of substance abuse disorders
- recent history of surgery or fracture to the cervical spine, thoracic spine, ribs, or shoulders (within 6 months)
- metabolic bone disease (including osteoporosis)
Show all 10Show fewer
- fusion or ankyloses
- osteomyelitis, pregnancy, vertebral basilar insufficiency, neoplastic disease, malignancy in the area of treatment
- actively treated for sleep disorders (including insomnia)
- uncontrolled congestive heart failure, COPD, hypertension, or other serious medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Professions Physical Therapy Clinic
Dallas, Texas, 75390-8876
About this study
This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to UTSW physicians with shoulder pain. The investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each group. The treatment group will also receive instruction to mobilize their thoracic spine and ribs each night before going to sleep.
Read the detailed description
Subjects with a chief complaint of musculoskeletal pain will be recruited from clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery. Subjects will be randomized into either the intervention or control group. The intervention group will receive education on sleep hygiene and instruction to use a foam roller to mobilize the thoracic spine and ribs just before the subject goes to sleep. The control group will receive education on sleep hygiene. Valid and reliable measures will be used to assess sleep quality (Pittsburgh Sleep Quality Index), pain (Numeric Pain Rating Scale), and function (SF-36 and ASES), as well as a sleep diary. Measures will be taken at baseline as well as two weeks after the subject's enrollment in the study.
- Conditions
- Shoulder Pain Chronic
- Being tested
- Self-mobilization, Sleep Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-mobilizationProcedure or surgery
Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.
Sleep EducationProcedure or surgery
Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.
| Study group | Role | What they receive |
|---|---|---|
| Self-mobilization | Experimental | Use of foam roller to mobilize thoracic spine and ribs every night before going to bed Receives: Procedure: Self-mobilization |
| Sleep Education | Active comparator | Education on sleep hygiene with tips for improving sleep. Receives: Procedure: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Index
Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance
Measured: Baseline, 1 week, and 2 weeks
Secondary outcomes (2)
Numeric Pain Rating Scale
Valid and reliable 11 point rating of pain, with higher scores indicating more pain
Measured: Baseline, 1 week, and 2 weeks
SF-36
Valid and reliable 36 item assessment of quality of life, with higher scores indicating lower disability
Measured: Baseline, 1 week, and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start20 Feb 2017
- Primary completion1 Oct 2019
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Pain ChronicStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tara Dickson, DPT, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088085
- Sponsor's protocol ID
- STU 092016-072
- Status last verified
- May 2020
- First submitted
- 8 Mar 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
- ClinicalTrials.gov ID
- NCT03088085
- Acronym / sponsor ID
- STU 092016-072
- Conditions
- Shoulder Pain Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 23 Mar 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 project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to UTSW physicians with shoulder pain. The investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each group. The treatment group will also receive instruction to mobilize their thoracic spine and ribs each night before going to sleep.
Detailed description
Subjects with a chief complaint of musculoskeletal pain will be recruited from clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery. Subjects will be randomized into either the intervention or control group. The intervention group will receive education on sleep hygiene and instruction to use a foam roller to mobilize the thoracic spine and ribs just before the subject goes to sleep. The control group will receive education on sleep hygiene. Valid and reliable measures will be used to assess sleep quality (Pittsburgh Sleep Quality Index), pain (Numeric Pain Rating Scale), and function (SF-36 and ASES), as well as a sleep diary. Measures will be taken at baseline as well as two weeks after the subject's enrollment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-mobilization | Experimental | Procedure: Self-mobilizationUse of foam roller to mobilize thoracic spine and ribs every night before going to bed |
| Sleep Education | Active comparator | Procedure: Sleep EducationEducation on sleep hygiene with tips for improving sleep. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Shoulder pain with associated sleeping disturbance
- Between the ages of 18-89
- Present to the clinics in the Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery at UTSW
Key exclusion criteria (10 listed)
- non-English speakers
- chronic pain or rheumatic disorders
- unstable psychopathology, cognitive impairment (including dementia)
- current or recent history (within 6 months) of substance abuse disorders
- recent history of surgery or fracture to the cervical spine, thoracic spine, ribs, or shoulders (within 6 months)
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 |
|---|---|---|
| Self-mobilizationSubjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed. | Procedure or surgery | Self-mobilization |
| Sleep EducationSubjects will be educated on sleep hygiene in order to improve likelihood of having good sleep. | Procedure or surgery | Sleep Education |
Primary outcome
Pittsburgh Sleep Index
Time frame: Baseline, 1 week, and 2 weeks
Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: Baseline, 1 week, and 2 weeks
SF-36
Time frame: Baseline, 1 week, and 2 weeks
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 19 May 2020.
- Individual participant dataSharing planned: No
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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.
Tara Dickson, DPT principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-mobilization and Sleep Education in people with Shoulder Pain Chronic, run by University of Texas Southwestern Medical Center at 1 site 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 3 inclusion and 10 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 19 May 2020. 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 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?
Pittsburgh Sleep Index (time frame: Baseline, 1 week, and 2 weeks). 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 19 May 2020.