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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03031158
Enrollment
24
Registered
2017-01-25
Start date
2017-02-01
Completion date
2018-03-13
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Brief summary

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.

Interventions

BEHAVIORALSFEX+H

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.

BEHAVIORALSFEX

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.

Sponsors

University of Delaware
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Age 60-85 2. Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification. 3. 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

1. Previous hip fracture repair or total hip replacement 2. Prominent component of radicular pain: CLBP with distal radiation below the knee 3. 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) 4. Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair) 5. Folstein Mini-Mental State Examination score of \<24 6. Severe visual or hearing impairment. 7. 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). 8. Significant pain in parts of the body other than the back or acute LBP. 9. Acute, ongoing illness. 10. Inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation) 11. Received physical therapy for their LBP within in the last 3 months.

Design outcomes

Primary

MeasureTime frame
Quebec Low Back Pain Disability ScaleChange in disability score from pre-intervention to 20 weeks later
Patient-Specific Functional ScaleChange in pain-related function score from pre-intervention to 20 weeks later

Secondary

MeasureTime frame
Walking Endurance as measured by the 6 minute walk testChange in walking endurance from pre-intervention to 20 weeks later
Walking speedChange in walking endurance from pre-intervention to 20 weeks later

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026