The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain

Not Applicable

Completed

• Conditions: Shoulder Pain Chronic
• Interventions: Procedure: Sleep Education; Procedure: Self-mobilization

• Registration Number: NCT03088085
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-23
• Primary Completion: 2019-10-01
• Status Verified: 2020-05
• Study Completion: 2020-05-01
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Education	Sleep Education	Education on sleep hygiene with tips for improving sleep.
Self-mobilization	Self-mobilization	Use of foam roller to mobilize thoracic spine and ribs every night before going to bed

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Index	Baseline, 1 week, and 2 weeks	Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance

Secondary Outcome Measures

Name	Time	Method
SF-36	Baseline, 1 week, and 2 weeks	Valid and reliable 36 item assessment of quality of life, with higher scores indicating lower disability
Numeric Pain Rating Scale	Baseline, 1 week, and 2 weeks	Valid and reliable 11 point rating of pain, with higher scores indicating more pain

Trial Locations

Locations (1)

Health Professions Physical Therapy Clinic; 🇺🇸 Dallas, Texas, United States