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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SFEX+H
SFEX
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Delaware

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SFEX+H

SFEX

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Quebec Low Back Pain Disability Scale
Patient-Specific Functional Scale

Secondary Outcome Measures

Walking Endurance as measured by the 6 minute walk test
Walking speed

Full Information

First Posted
January 23, 2017
Last Updated
October 8, 2018
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT03031158
Brief Title
Hip-spine Intervention for Older Adults With Chronic Low Back Pain
Official Title
Pilot Trial of a Hip-spine Intervention for Older Adults With a Primary Complaint of Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFEX+H
Arm Type
Experimental
Arm Description
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.
Arm Title
SFEX
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SFEX+H
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SFEX
Intervention Description
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 Outcome Measure Information:
Title
Quebec Low Back Pain Disability Scale
Time Frame
Change in disability score from pre-intervention to 20 weeks later
Title
Patient-Specific Functional Scale
Time Frame
Change in pain-related function score from pre-intervention to 20 weeks later
Secondary Outcome Measure Information:
Title
Walking Endurance as measured by the 6 minute walk test
Time Frame
Change in walking endurance from pre-intervention to 20 weeks later
Title
Walking speed
Time Frame
Change in walking endurance from pre-intervention to 20 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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