Back to resultsThe Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
Primary Purpose
Shoulder Pain Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-mobilization
Sleep Education
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain Chronic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- Health Professions Physical Therapy Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-mobilization
Sleep Education
Arm Description
Use of foam roller to mobilize thoracic spine and ribs every night before going to bed
Education on sleep hygiene with tips for improving sleep.
Outcomes
Primary Outcome Measures
Pittsburgh Sleep Index
Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance
Secondary Outcome Measures
Numeric Pain Rating Scale
Valid and reliable 11 point rating of pain, with higher scores indicating more pain
SF-36
Valid and reliable 36 item assessment of quality of life, with higher scores indicating lower disability
Full Information
NCT ID
NCT03088085
First Posted
March 8, 2017
Last Updated
May 15, 2020
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03088085
Brief Title
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
Official Title
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
May 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-mobilization
Arm Type
Experimental
Arm Description
Use of foam roller to mobilize thoracic spine and ribs every night before going to bed
Arm Title
Sleep Education
Arm Type
Active Comparator
Arm Description
Education on sleep hygiene with tips for improving sleep.
Intervention Type
Procedure
Intervention Name(s)
Self-mobilization
Intervention Description
Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.
Intervention Type
Procedure
Intervention Name(s)
Sleep Education
Intervention Description
Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Index
Description
Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance
Time Frame
Baseline, 1 week, and 2 weeks
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
Valid and reliable 11 point rating of pain, with higher scores indicating more pain
Time Frame
Baseline, 1 week, and 2 weeks
Title
SF-36
Description
Valid and reliable 36 item assessment of quality of life, with higher scores indicating lower disability
Time Frame
Baseline, 1 week, and 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tara Dickson, DPT
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Professions Physical Therapy Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8876
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
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