Clinical trial NCT05724160: Using Non-Weightbearing Stationary Elliptical Machines for Patients with Chronic Low Back Pain
Official title: Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients with Chronic Nonspecific Low Back Pain; a Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Low Back Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Fitness Cubed Inc.
First posted: 2023-02-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Heart rate
timeFrame: 8 weeks
measure: Pain Visual Analogue Scale (VAS)
timeFrame: 8 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 8 weeks
measure: Oswestry Low Back Pain Disability Index (ODI)
timeFrame: 8 weeks
measure: Transversus abdominis endurance (TAE)
timeFrame: 8 weeks
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 8 weeks
measure: Patient reported outcome measures (PROM)
timeFrame: 8 weeks
Secondary outcomes:
measure: Duration of exercise in each session
timeFrame: 8 weeks
measure: Satisfaction rate (0-10)
timeFrame: 8 weeks
measure: Compliance (duration of continuing the sessions)
timeFrame: 8 weeks
measure: Intention to continue the sessions (0-10)
timeFrame: 8 weeks
measure: Distance passed on the stationary elliptical
timeFrame: 8 weeks
measure: Total strides
timeFrame: 8 weeks
measure: Time series of the stride/minute
timeFrame: 8 weeks
measure: Average strides/minute
timeFrame: 8 weeks
measure: Distance traveled in each section
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
citation: Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008 Jan-Feb;8(1):8-20. doi: 10.1016/j.spinee.2007.10.005.
citation: van Tulder M, Becker A, Bekkering T, Breen A, del Real MT, Hutchinson A, Koes B, Laerum E, Malmivaara A; COST B13 Working Group on Guidelines for the Management of Acute Low Back Pain in Primary Care. Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S169-91. doi: 10.1007/s00586-006-1071-2. No abstract available.
citation: Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017 Feb 18;389(10070):736-747. doi: 10.1016/S0140-6736(16)30970-9. Epub 2016 Oct 11.
citation: Patrick N, Emanski E, Knaub MA. Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005.
citation: Henchoz Y, Kai-Lik So A. Exercise and nonspecific low back pain: a literature review. Joint Bone Spine. 2008 Oct;75(5):533-9. doi: 10.1016/j.jbspin.2008.03.003. Epub 2008 Sep 17.
citation: Illes ST. [Low back pain: when and what to do]. Orv Hetil. 2015 Aug 16;156(33):1315-20. doi: 10.1556/650.2015.30232. Hungarian.
citation: Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
citation: Owen PJ, Miller CT, Mundell NL, Verswijveren SJJM, Tagliaferri SD, Brisby H, Bowe SJ, Belavy DL. Which specific modes of exercise training are most effective for treating low back pain? Network meta-analysis. Br J Sports Med. 2020 Nov;54(21):1279-1287. doi: 10.1136/bjsports-2019-100886. Epub 2019 Oct 30.
citation: Marshall PW, Kennedy S, Brooks C, Lonsdale C. Pilates exercise or stationary cycling for chronic nonspecific low back pain: does it matter? a randomized controlled trial with 6-month follow-up. Spine (Phila Pa 1976). 2013 Jul 1;38(15):E952-9. doi: 10.1097/BRS.0b013e318297c1e5.
citation: Chulliyil SC, Sheth MS, Vyas NJ. EFFECT OF TREADMILL WALKING VERSUS STATIONARY CYCLING ON PAIN, TRANSVERSUS ABDOMINIS ENDURANCE, DISABILITY & QUALITY OF LIFE IN NON-SPECIFIC CHRONIC LOW BACK PAIN: A QUASI EXPERIMENTAL STUDY. Int J Physiother Res. 2018;6(5):2848-56.
citation: Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
citation: Kisner C, Colby L. The spine: exercise interventions. Therapeutic exercise: foundations and techniques 5th ed Philadelphia: FA Davis Company. 2007:439-81.