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CompletedNCT03031158Updated Oct 9, 2018

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

An interventional study of SFEX+H and SFEX in Low Back Pain, sponsored by University of Delaware. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by University of Delaware · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
60 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Low Back Pain
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 85 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    SFEX+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.

    Behavioral: SFEX+H

  • Active comparator
    SFEX

    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.

    Behavioral: SFEX

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.

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What researchers measure

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

07

Study locations

1 site
  • University of Delaware
    Newark, Delaware 19713, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03031158
Lead sponsor
University of Delaware
Responsible party
Gregory Evan Hicks (Associate Professor, University of Delaware) — Principal investigator
First posted
Jan 25, 2017
Start date
Feb 1, 2017
Primary completion
Mar 13, 2018
Completion
Mar 13, 2018
Last update
Oct 9, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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