Clinical trial NCT03088085: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain Chronic
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pittsburgh Sleep Index
timeFrame: Baseline, 1 week, and 2 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: Baseline, 1 week, and 2 weeks
measure: SF-36
timeFrame: Baseline, 1 week, and 2 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Health Professions Physical Therapy Clinic
state: Texas
Study officials:
affiliation: Assistant Professor
name: Tara Dickson, DPT
role: PRINCIPAL_INVESTIGATOR
References: