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

NCT ID: NCT03088085

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2020-05-01

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.

Conditions

Shoulder Pain Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Self-mobilization

Use of foam roller to mobilize thoracic spine and ribs every night before going to bed

Group Type: EXPERIMENTAL

Self-mobilization

Intervention Type: PROCEDURE

Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.

Sleep Education

Education on sleep hygiene with tips for improving sleep.

Group Type: ACTIVE_COMPARATOR

Sleep Education

Intervention Type: PROCEDURE

Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.

Interventions

Self-mobilization

Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.

Intervention Type: PROCEDURE

Sleep Education

Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Dickson, DPT

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Health Professions Physical Therapy Clinic

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 092016-072

Identifier Type: -

Identifier Source: org_study_id