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

Shoulder Pain Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088085
• Other study ID #: STU 092016-072
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: May 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain
• Shoulder Pain Chronic

Intervention

Procedure:
• Self-mobilization
Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.
• Sleep Education
Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.

Locations

Country	Name	City	State
United States	Health Professions Physical Therapy Clinic	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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