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

NCT03088085 | Completed

• 1 other identifier: STU 092016-072
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain Chronic

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Sleep Index

  Valid and reliable 19 item assessment of sleep quality, with higher scores indicating greater sleep disturbance

  Baseline, 1 week, and 2 weeks

Secondary Outcomes (2)

• Numeric Pain Rating Scale

  Baseline, 1 week, and 2 weeks

• SF-36

  Baseline, 1 week, and 2 weeks

Study Arms (2)

Self-mobilization

EXPERIMENTAL

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

Procedure: Self-mobilization

Sleep Education

ACTIVE COMPARATOR

Education on sleep hygiene with tips for improving sleep.

Procedure: Sleep Education

Interventions

Self-mobilization PROCEDURE

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

Self-mobilization

Sleep Education PROCEDURE

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

Sleep Education

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Health Professions Physical Therapy Clinic

Dallas, Texas, 75390-8876, United States

Location

Study Officials

• Tara Dickson, DPT

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 23, 2017
• Study Start: February 20, 2017
• Primary Completion: October 1, 2019
• Study Completion: May 1, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)