Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 11:10 AM
Study NCT ID:
NCT05724160
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2023-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Non-Weightbearing Stationary Elliptical Machines for Patients with Chronic Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No groups will be masked'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '32 patients with non-specific low back pain will be allocated to the physiotherapy group.\n\n32 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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2023-01-12', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '8 weeks', 'description': 'Heart rate in beats/minute'}, {'measure': 'Pain Visual Analogue Scale (VAS)', 'timeFrame': '8 weeks', 'description': 'Pain scores based on the Visual Analogue Scale 0-10'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Oswestry Low Back Pain Disability Index (ODI)', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Transversus abdominis endurance (TAE)', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Fear-Avoidance Beliefs Questionnaire (FABQ)', 'timeFrame': '8 weeks', 'description': "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)"}, {'measure': 'Patient reported outcome measures (PROM)', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Duration of exercise in each session', 'timeFrame': '8 weeks', 'description': 'Duration of exercise in each session as feedback on the session'}, {'measure': 'Satisfaction rate (0-10)', 'timeFrame': '8 weeks', 'description': 'Satisfaction rate (0-10) as feedback on the session'}, {'measure': 'Compliance (duration of continuing the sessions)', 'timeFrame': '8 weeks', 'description': 'Compliance (duration of continuing the sessions) as feedback on the session'}, {'measure': 'Intention to continue the sessions (0-10)', 'timeFrame': '8 weeks', 'description': 'Intention to continue the sessions (0-10) as feedback on the session'}, {'measure': 'Distance passed on the stationary elliptical', 'timeFrame': '8 weeks', 'description': 'Distance passed on the stationary elliptical as elliptical measurement in kilometers'}, {'measure': 'Total strides', 'timeFrame': '8 weeks', 'description': 'Total strides as elliptical measurement'}, {'measure': 'Time series of the stride/minute', 'timeFrame': '8 weeks', 'description': 'Time series of the stride/minute as elliptical measurement'}, {'measure': 'Average strides/minute', 'timeFrame': '8 weeks', 'description': 'Average strides/minute as elliptical measurement'}, {'measure': 'Distance traveled in each section', 'timeFrame': '8 weeks', 'description': 'Distance traveled in each section as elliptical measurement in kilometers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Low-back Pain', 'Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '10470716', 'type': 'BACKGROUND', '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.'}, {'pmid': '18164449', 'type': 'BACKGROUND', '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.'}, {'pmid': '16550447', 'type': 'BACKGROUND', '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.'}, {'pmid': '27745712', 'type': 'BACKGROUND', '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.'}, {'pmid': '24994051', 'type': 'BACKGROUND', '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.'}, {'pmid': '18801686', 'type': 'BACKGROUND', '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.'}, {'pmid': '26256495', 'type': 'BACKGROUND', '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.'}, {'pmid': '15867409', 'type': 'BACKGROUND', '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.'}, {'pmid': '31666220', 'type': 'BACKGROUND', '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.'}, {'pmid': '23615384', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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.'}, {'pmid': '11074683', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Kisner C, Colby L. The spine: exercise interventions. Therapeutic exercise: foundations and techniques 5th ed Philadelphia: FA Davis Company. 2007:439-81.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. 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.\n2. Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program\n\nParticipants will participate in 60 minute training sessions to see if there are effects to their CLBP.', 'detailedDescription': '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:\n\n1. 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\n2. to assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 to 70 years and CLBP (\\>12 wk) located between the costal margins and inferior gluteal folds.\n\nExclusion Criteria:\n\n* The presence of a postural abnormality contributing to the diagnosis reported by an expert spine surgeon\n* 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)\n* History of back surgery, inflammatory joint disease, severe osteoporosis\n* 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)\n* Pregnancy\n* Ankle and foot injuries inhibiting them from cycling recently (\\<3 mo.)\n* Participation in another exercise program or physiotherapy (i.e., manipulation, mobilization, range of motion, massage).'}, 'identificationModule': {'nctId': 'NCT05724160', 'acronym': 'Cubii', 'briefTitle': 'Using Non-Weightbearing Stationary Elliptical Machines for Patients with Chronic Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Using Non-Weightbearing Stationary Elliptical Machines and Virtual Reality for Patients with Chronic Nonspecific Low Back Pain; a Prospective Clinical Trial', 'orgStudyIdInfo': {'id': '2022P001905'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'NSLBP treated with Physiotherapy', 'description': '32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.', 'interventionNames': ['Other: Physiotherapy Protocol']}, {'type': 'OTHER', 'label': 'NSLBP treated with Physiotherapy + Sitting ellipticals', 'description': '32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert together with planned training using sitting ellipticals', 'interventionNames': ['Other: Using sitting ellipticals', 'Other: Physiotherapy Protocol']}], 'interventions': [{'name': 'Using sitting ellipticals', 'type': 'OTHER', 'otherNames': ['Cubii Ellipticals'], 'description': 'Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical', 'armGroupLabels': ['NSLBP treated with Physiotherapy + Sitting ellipticals']}, {'name': 'Physiotherapy Protocol', 'type': 'OTHER', 'otherNames': ['Physiotherapy'], 'description': 'Routine physiotherapy protocol', 'armGroupLabels': ['NSLBP treated with Physiotherapy', 'NSLBP treated with Physiotherapy + Sitting ellipticals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All data acquired as specified by this protocol will be maintained and monitored by approved study staff. Approved study staff will be responsible for collecting the signed consent forms. All electronic data and subject information will be secured on non-networking password protected computers; all paperwork will be secured in locked filing cabinets. All electronic data and subject information will be secured in REDCap and will be secured on non-networking password protected computers to which only study staff will have access; all paper work will be secured in locked filing cabinets.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fitness Cubed Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Foot and Ankle Research and Innovation Laboratory', 'investigatorFullName': 'Soheil Ashkani Esfahani', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}