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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain Chronic
• Intervention / Treatment: Procedure: Self-mobilization; Procedure: Sleep Education

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-8876
      • Health Professions Physical Therapy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-mobilization; Use of foam roller to mobilize thoracic spine and ribs every night before going to bed	Procedure: Self-mobilization; Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.
Active Comparator: Sleep Education; Education on sleep hygiene with tips for improving sleep.	Procedure: Sleep Education; Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Tara Dickson, DPT, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: STU 092016-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No