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Completed

NCT Number: NCT03031158

Hip-spine Intervention for Older Adults With Chronic Low Back Pain

Low back pain (LBP) is extremely common in older adults and is associated with a host of negative consequences, including decreased physical function and increased healthcare utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are more prevalent and associated with greater disability than among older adults without LBP. This study will investigate a novel intervention designed to improve LBP-related disability by combining a typical spine-focused exercise program with a hip-focused intervention.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 60-85
  • Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification.
  • Presence of at least 1 hip impairment denoted by the American College of Rheumatology as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation or morning stiffness of the hip of <60 minutes.

Exclusion criteria

  • Previous hip fracture repair or total hip replacement
  • Prominent component of radicular pain: CLBP with distal radiation below the knee
  • Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine)
  • Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair)
  • Folstein Mini-Mental State Examination score of <24
  • Severe visual or hearing impairment.
  • Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of sensation over saddle region, significant disturbances in bowel and bladder function).
  • Significant pain in parts of the body other than the back or acute LBP.
  • Acute, ongoing illness.
  • Inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation)
  • Received physical therapy for their LBP within in the last 3 months.

Treatment and study plan

SFEX+H

Behavioral

Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.

SFEX

Behavioral

Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.

Primary outcomes

  1. Quebec Low Back Pain Disability Scale

    Time frame: Change in disability score from pre-intervention to 20 weeks later

  2. Patient-Specific Functional Scale

    Time frame: Change in pain-related function score from pre-intervention to 20 weeks later

Secondary outcomes

  1. Walking Endurance as measured by the 6 minute walk test

    Time frame: Change in walking endurance from pre-intervention to 20 weeks later

  2. Walking speed

    Time frame: Change in walking endurance from pre-intervention to 20 weeks later

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Pilot Trial of a Hip-spine Intervention for Older Adults With a Primary Complaint of Low Back Pain

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Oct 9, 2018

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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