Using Non-Weightbearing Stationary Elliptical Machines for Patients With Chronic Low Back Pain

Low Back Pain Clinical Trial

— Cubii  

Official title:

Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients With Chronic Nonspecific Low Back Pain; A Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724160
• Other study ID #: 2022P001905
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: March 22, 2027

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: Soheil Ashkani-Esfahani, MD
• Phone: 6177265303
• Email: sashkaniesfahani[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 22, 2027
• Est. primary completion date: September 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• Using sitting ellipticals
Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical
• Physiotherapy Protocol
Routine physiotherapy protocol

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Kisner C, Colby L. The spine: exercise interventions. Therapeutic exercise: foundations and techniques 5th ed Philadelphia: FA Davis Company. 2007:439-81.

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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate	Heart rate in beats/minute	8 weeks
Primary	Pain Visual Analogue Scale (VAS)	Pain scores based on the Visual Analogue Scale 0-10	8 weeks
Primary	Pain Catastrophizing Scale (PCS)	Mental health based on the Pain Catastrophizing Scale (PCS). 13-item questionnaire to identify catastrophic thoughts or feelings in relation to painful experiences. The total score ranges from 0 to 52, with high scores indicating that more catastrophic thoughts or feelings are experienced.	8 weeks
Primary	Oswestry Low Back Pain Disability Index (ODI)	Measure of disability based on the Oswestry Low Back Pain Disability Index (ODI). Version 2, 10-item questionnaire on how LBP affects aspects of their life (0%-100% scoring.	8 weeks
Primary	Transversus abdominis endurance (TAE)	Abdominal strength based on Transversus abdominis endurance (TAE). Holding or tonic capacity of transversus abdominis measured by the number of 10-second holds (up to 10) using pressure biofeedback in prone position.	8 weeks
Primary	Fear-Avoidance Beliefs Questionnaire (FABQ)	Patient's beliefs about the potential harm of work or general physical activity to their back pain. Two subscales within the FABQ have been identified, a 7-item work subscale score (FABQw, score range 0-42), and a 4-item physical activity subscale score (FABQa, score range 0-24)	8 weeks
Primary	Patient reported outcome measures (PROM)	PROMIS-29 profile v1.0 (for Physical function, anxiety, depression, fatigue, sleep disturbance, satisfaction with social role, pain inference (+pain inference short form 6b), pain intensity, depression, mood and anxiety.	8 weeks
Secondary	Duration of exercise in each session	Duration of exercise in each session as feedback on the session	8 weeks
Secondary	Satisfaction rate (0-10)	Satisfaction rate (0-10) as feedback on the session	8 weeks
Secondary	Compliance (duration of continuing the sessions)	Compliance (duration of continuing the sessions) as feedback on the session	8 weeks
Secondary	Intention to continue the sessions (0-10)	Intention to continue the sessions (0-10) as feedback on the session	8 weeks
Secondary	Distance passed on the stationary elliptical	Distance passed on the stationary elliptical as elliptical measurement in kilometers	8 weeks
Secondary	Total strides	Total strides as elliptical measurement	8 weeks
Secondary	Time series of the stride/minute	Time series of the stride/minute as elliptical measurement	8 weeks
Secondary	Average strides/minute	Average strides/minute as elliptical measurement	8 weeks
Secondary	Distance traveled in each section	Distance traveled in each section as elliptical measurement in kilometers	8 weeks