Using Non-Weightbearing Stationary Elliptical Machines for Patients with Chronic Low Back Pain
NCT ID: NCT05724160
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2023-09-18
2024-12-22
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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NSLBP treated with Physiotherapy
32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.
Physiotherapy Protocol
Routine physiotherapy protocol
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
Using sitting ellipticals
Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
Physiotherapy Protocol
Routine physiotherapy protocol
Interventions
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Using sitting ellipticals
Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
Physiotherapy Protocol
Routine physiotherapy protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Fitness Cubed Inc.
UNKNOWN
Responsible Party
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Soheil Ashkani Esfahani
Director, Foot and Ankle Research and Innovation Laboratory
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Kisner C, Colby L. The spine: exercise interventions. Therapeutic exercise: foundations and techniques 5th ed Philadelphia: FA Davis Company. 2007:439-81.
Other Identifiers
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2022P001905
Identifier Type: -
Identifier Source: org_study_id
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