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

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

Sponsors

Lead sponsor: University of Texas Southwestern Medical Center

Source 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.

Overall Status Completed
Start Date February 20, 2017
Completion Date May 1, 2020
Primary Completion Date October 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pittsburgh Sleep Index Baseline, 1 week, and 2 weeks
Secondary Outcome
Measure Time Frame
Numeric Pain Rating Scale Baseline, 1 week, and 2 weeks
SF-36 Baseline, 1 week, and 2 weeks
Enrollment 48
Condition
Intervention

Intervention type: Procedure

Intervention name: Self-mobilization

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

Arm group label: Self-mobilization

Intervention type: Procedure

Intervention name: Sleep Education

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

Arm group label: Sleep Education

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

Gender: All

Minimum age: 18 Years

Maximum age: 89 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Tara Dickson, DPT Principal Investigator Assistant Professor
Location
facility
Health Professions Physical Therapy Clinic
Location Countries

United States

Verification Date

May 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Self-mobilization

Arm group type: Experimental

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

Arm group label: Sleep Education

Arm group type: Active Comparator

Description: Education on sleep hygiene with tips for improving sleep.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov