Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain
Purpose
The goal of this clinical trial is to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed, Inc.) on patient well-being with chronic lower back pain (CLBP). The main questions it aims to answer are: 1. Assess the effect of non-weightbearing stationary ellipticals on clinical outcomes inclduing vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP. 2. Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program Participants will participate in 60 minute training sessions to see if there are effects to their CLBP.
Conditions
- Chronic Low-back Pain
- Low Back Pain
Eligibility
- Eligible Ages
- Between 18 Years and 70 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adults aged 18 to 70 years and CLBP (>12 wk) located between the costal margins and inferior gluteal folds.
Exclusion Criteria
- The presence of a postural abnormality contributing to the diagnosis reported by an expert spine surgeon - Pain radiating below the knee, past medical history or current symptomatic lumbar disc hernia or fracture based on expert reports (i.e. orthopedic surgeon or radiologist) - History of back surgery, inflammatory joint disease, severe osteoporosis - A metabolic disease affecting the CLBP, or neuromuscular disease (as assessed by the American College of Sports Medicine pre-exercise screening tool for cardiovascular risk factors prior to entry into an exercise program) - Pregnancy - Ankle and foot injuries inhibiting them from cycling recently (<3 mo.) - Participation in another exercise program or physiotherapy (i.e., manipulation, mobilization, range of motion, massage).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- 32 patients with non-specific low back pain will be allocated to the physiotherapy group. 32 patients with non-specific low back pain will be allocated to the physiotherapy + sitting elliptical group. They will be receive routine physiotherapy care based on the protocols for non-specific low back pain and using the ellipticals will not affect the process of the treatment.
- Primary Purpose
- Other
- Masking
- None (Open Label)
- Masking Description
- No groups will be masked
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other NSLBP treated with Physiotherapy |
32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert. |
|
|
Other NSLBP treated with Physiotherapy + Sitting ellipticals |
32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert together with planned training using sitting ellipticals |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
There are controversies on whether exercise is more effective than placebo among different clinical studies specifically in acute LBP; however, in CLBP cases, evidence strongly recommends that exercise is more effective than conservative treatment on pain and functional abilities, especially individually designed exercise programs for stabilizing and strengthening. The aims of the present study are: 1. to assess the effect of non-weightbearing stationary ellipticals (Cubii, Fitness Cubed Inc.) on clinical outcomes including vital signs, pain, disability, analgesic use, mental health, abdominal muscle strength, and compliance in patients with CLBP 2. to assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program. The training sessions will be up to 60 minutes and will include a) introduction to the goals of the session (5 minutes), b) warm-up and stretching (10 minutes), c) low resistance flat road cycling (low resistance, low cadence; 10 minutes), d) flat road cycling (high resistance, low cadence; 10 minutes), e) flat road sprint (low resistance, high cadence; 10 minutes), f) warm-down, whole-body stretching, questions and answers (Q&A; 10-15 minutes) obtained from investigations on the similar topic. The training sessions will be supervised by both an expert clinical researcher with MD degree who is familiar with healthcare principles for these patients and also by a US licensed board-certified orthopaedic surgeon, who is responsible for providing routine orthopaedic care for the patients in this study.