Adults 60 to 85, any sex, with Chronic Low-back Pain or Hip Impairments. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Quebec Back Pain Disability ScalePrimary· Baseline to 8-week assessment (i.e. post-intervention)
A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.
Baseline
Group
Value
95% CI
Hip-focused
27.9
± 15.8
Spine-focused
27.9
± 15.5
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
16.7
± 11.7
Spine-focused
20.3
± 14.3
10-Meter Walk Test at Self-Selected Speed (10MWT)Primary· Baseline to 8-week assessment (i.e. post-intervention)
A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Baseline
Group
Value
95% CI
Hip-focused
1.12
± 0.25
Spine-focused
1.12
± 0.24
8-week (post-intervention) assessment
Group
Value
95% CI
Hip-focused
1.2
± 0.24
Spine-focused
1.21
± 0.23
Quebec Back Pain Disability ScaleSecondary· Baseline to the 6-month assessment
A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.
Baseline
Group
Value
95% CI
Hip-focused
27.9
± 15.8
Spine-focused
27.9
± 15.5
6-months (final assessment)
Group
Value
95% CI
Hip-focused
15.8
± 12.5
Spine-focused
17.3
± 14.1
10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)Secondary· Baseline to 6-months
A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Baseline
Group
Value
95% CI
Hip-focused
1.12
± 0.25
Spine-focused
1.12
± 0.24
6-months
Group
Value
95% CI
Hip-focused
1.21
± 0.25
Spine-focused
1.24
± 0.22
10-Meter Walk Test at Fast Speed (10MWT)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A performance test where participants walk along a 10-meter linear pathway 'as quickly as possible', for three trials. Average fast gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Baseline
Group
Value
95% CI
Hip-focused
1.57
± 0.34
Spine-focused
1.59
± 0.38
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
1.65
± 0.31
Spine-focused
1.67
± 0.32
6-months (final assessment)
Group
Value
95% CI
Hip-focused
1.63
± 0.31
Spine-focused
1.66
± 0.34
Timed Up-and-Go (TUG)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A performance test where participants rise from a chair, walk 3 meters at their regular pace, and return to a seated position in the same chair. One practice trial is performed followed by three timed trials; performance times are averaged. Greater times indicate worse physical function.
Baseline
Group
Value
95% CI
Hip-focused
9.73
± 2.68
Spine-focused
9.46
± 2.07
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
8.92
± 1.89
Spine-focused
9.12
± 1.93
6-months (final assessment)
Group
Value
95% CI
Hip-focused
8.99
± 1.93
Spine-focused
8.82
± 2.03
Six-Minute Walk Test (6MWT)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A performance test where participants are asked to walk as far as they can in six minutes around a continuous track. Greater distances (in meters) indicate better mobility and exercise tolerance.
Baseline
Group
Value
95% CI
Hip-focused
451.0
± 116.7
Spine-focused
451.9
± 101.6
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
489.0
± 100.4
Spine-focused
468.2
± 108.8
6-months (final assessment)
Group
Value
95% CI
Hip-focused
487.8
± 100.1
Spine-focused
477.9
± 105.9
30 Second Chair Stand TestSecondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A performance test where participants perform as many sit-to-stands as possible in 30 seconds while their arms are folded across their chest. The number of stands are counted. Higher numbers correlate with better scores.
Baseline
Group
Value
95% CI
Hip-focused
10
± 3.7
Spine-focused
10
± 3.2
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
11
± 3.1
Spine-focused
11
± 3.3
6-months (final assessment)
Group
Value
95% CI
Hip-focused
12
± 3.4
Spine-focused
11
± 3.8
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand TestSecondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
Post-test pain intensities, i.e., 0-10, for both the Six-Minute Walk Test and the 30 Second Chair Stand Test were used in the calculation of aggregate movement-evoked pain. Scores for this measure were the sum of both post-test pain intensities, resulting in a score range of 0-20, where higher numbers indicate worse pain.
Baseline
Group
Value
95% CI
Hip-focused
6.4
± 4.3
Spine-focused
6.7
± 4.7
8-weeks (post-intervention)
Group
Value
95% CI
Hip-focused
3.6
± 3.6
Spine-focused
5.2
± 4.5
6-months (final assessment)
Group
Value
95% CI
Hip-focused
3.8
± 4.1
Spine-focused
4.1
± 4.1
Patient Health Questionnaire-9 (PHQ-9)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A 9-item questionnaire that assesses the presence/absence of depressive symptoms. Scores above 5 indicate likeliness of depressive symptoms. Scores range from 0-27.
Baseline
Group
Value
95% CI
Hip-focused
3.3
± 4.1
Spine-focused
2.9
± 3.6
8 week (post-intervention)
Group
Value
95% CI
Hip-focused
2.5
± 2.7
Spine-focused
2.6
± 3.6
6 months (final assessment)
Group
Value
95% CI
Hip-focused
2.4
± 2.8
Spine-focused
2.5
± 3.5
Low Back Activity Confidence Scale (LOBACS)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A 15-item questionnaire that measures a person's confidence in their ability to perform different activities, including carrying, pushing, sitting, walking, and exercising, which may be directly affected by low back pain. There is an overall score, as well as three Self-Efficacy Subscales: Functional, Self-Regulatory, and Exercise. Overall, as well as subscales, range from 0-100%, where higher numbers indicate higher confidence.
Baseline: Overall
Group
Value
95% CI
Hip-focused
70.1
± 16.4
Spine-focused
68.9
± 18.8
8-week: Overall
Group
Value
95% CI
Hip-focused
78.4
± 14.9
Spine-focused
74.3
± 19.9
6-month: Overall
Group
Value
95% CI
Hip-focused
76.2
± 18.8
Spine-focused
73.0
± 20.3
Baseline: Functional Subscale
Group
Value
95% CI
Hip-focused
56.2
± 23.9
Spine-focused
54.3
± 23.4
8-week: Functional Subscale
Group
Value
95% CI
Hip-focused
68.2
± 21.1
Spine-focused
63.1
± 26.0
6-month: Functional Subscale
Group
Value
95% CI
Hip-focused
70.0
± 23.9
Spine-focused
65.2
± 25.6
Baseline: Self-Regulatory Subscale
Group
Value
95% CI
Hip-focused
78.4
± 19.1
Spine-focused
77.9
± 23.6
8-week: Self-Regulatory Subscale
Group
Value
95% CI
Hip-focused
86.3
± 17.7
Spine-focused
82.5
± 21.6
Hip Disability and Osteoarthritis Outcome Score (HOOS)Secondary· Baseline, 8-weeks (i.e. post-intervention), and 6-months
A 40-item questionnaire that contains five domains (symptoms, pain, activity of daily living (ADL), sport and recreation, and quality of life). Each scale ranges from 0-100, where higher scores are better, indicating lower hip-related disability.
Baseline Symptoms
Group
Value
95% CI
Hip-focused
67.8
± 18.3
Spine-focused
68.6
± 15.0
8-weeks Symptoms
Group
Value
95% CI
Hip-focused
80.6
± 12.8
Spine-focused
77.4
± 15.6
6-months Symptoms
Group
Value
95% CI
Hip-focused
80.4
± 13.6
Spine-focused
81.6
± 15.5
Baseline Pain
Group
Value
95% CI
Hip-focused
56.1
± 12.4
Spine-focused
57.7
± 11.4
8-weeks Pain
Group
Value
95% CI
Hip-focused
73.8
± 13.7
Spine-focused
71.9
± 17.2
6-months Pain
Group
Value
95% CI
Hip-focused
74.1
± 15.6
Spine-focused
76.5
± 17.1
Baseline ADL
Group
Value
95% CI
Hip-focused
64.9
± 16.7
Spine-focused
66.0
± 16.6
8-weeks ADL
Group
Value
95% CI
Hip-focused
81.1
± 13.9
Spine-focused
78.1
± 16.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected from baseline to the 6-month post-baseline final assessment..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Hip-focused
Serious: 9/91 (10%)
Deaths: 0/91
Spine-focused
Serious: 4/93 (4%)
Deaths: 0/93
Serious adverse events (10 terms)
Reaction
System
Hip-focused
Spine-focused
Surgical and Medical Procedures-other, specify
Surgical and medical procedures
—
—
Chest Pain
Cardiac disorders
—
—
Myocardial Infarction
Cardiac disorders
—
—
Atrial Fibrillation
Cardiac disorders
—
—
Cardiac Disorders-others, specify
Cardiac disorders
—
—
Cough
Respiratory, thoracic and mediastinal disorders
—
—
Heart Failure
Cardiac disorders
—
—
Respiratory, Thoracic and Mediastinal Disorders-other, specify
Older adults with chronic low back pain (LBP) are at a greater risk for disability, loss of independence, and lower quality of life. Experts agree that LBP is not a homogeneous condition, and treatments should differ based upon clinical presentation. Our past work indicates that all of these hip and lumbar spine impairments may contribute to worse physical function and greater disability, but the relative importance of each impairment is unclear. Thus, clinicians have limited evidence to draw on for treatment decisions for this patient population. We have identified a vulnerable subgroup of older adults with hip and low back pain. The purpose of this study is to randomize participants into one of two treatment arms and analyze the outcomes.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06891625 — Movement Performance in Persons With Chronic Back Pain
· NA
· recruiting
NCT06568198 — Modulation Effect of tACS on Chronic Low Back Pain
· Phase 2
· recruiting
NCT06825390 — AuriculoTherapy NeuroImaging
· NA
· recruiting
NCT04824248 — Weight Reduction in CLBP
· NA
· recruiting
NCT07055802 — Effects Of Inversion Table Therapy Vs MT On Pain And Lumbar Flexibility In Patients With Chronic Low Back Pain
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Delaware
Last refreshed: 11 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009837.