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Completed

NCT Number: NCT03088085

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Professions Physical Therapy Clinic

Dallas, Texas, 75390-8876, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-mobilization

Procedure

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

Sleep Education

Procedure

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

Primary outcomes

  1. Pittsburgh Sleep Index

    Time frame: Baseline, 1 week, and 2 weeks

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

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: Baseline, 1 week, and 2 weeks

    Valid and reliable 11 point rating of pain, with higher scores indicating more pain

  2. SF-36

    Time frame: Baseline, 1 week, and 2 weeks

    Valid and reliable 36 item assessment of quality of life, with higher scores indicating lower disability

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Mar 23, 2017
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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