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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031158
• Other study ID #: 943328
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: October 2018
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• 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. The intervention will be delivered twice weekly for 8 weeks.
• 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. The intervention will be delivered twice weekly for 8 weeks.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quebec Low Back Pain Disability Scale		Change in disability score from pre-intervention to 20 weeks later
Primary	Patient-Specific Functional Scale		Change in pain-related function score from pre-intervention to 20 weeks later
Secondary	Walking Endurance as measured by the 6 minute walk test		Change in walking endurance from pre-intervention to 20 weeks later
Secondary	Walking speed		Change in walking endurance from pre-intervention to 20 weeks later