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

NCT05724160 | Completed DMC

• 1 other identifier: 2022P001905
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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. 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. 2.Assess the effect of placing the patients into an interactive virtual environment during the exercise sessions on the outcomes of the program

Conditions

Chronic Low-back Pain; Low Back Pain

Outcome Measures

Primary Outcomes (7)

• Heart rate

  Heart rate in beats/minute

  8 weeks

• Pain Visual Analogue Scale (VAS)

  Pain scores based on the Visual Analogue Scale 0-10

  8 weeks

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• Duration of exercise in each session

  8 weeks

• Satisfaction rate (0-10)

  8 weeks

• Compliance (duration of continuing the sessions)

  8 weeks

• Intention to continue the sessions (0-10)

  8 weeks

• Distance passed on the stationary elliptical

  8 weeks

Study Arms (2)

NSLBP treated with Physiotherapy

OTHER

32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert.

Other: Physiotherapy Protocol

NSLBP treated with Physiotherapy + Sitting ellipticals

OTHER

32 patients with non-specific low back pain receiving routine protocol-based physiotherapy care by an expert together with planned training using sitting ellipticals

Other: Using sitting ellipticals; Other: Physiotherapy Protocol

Interventions

Using sitting ellipticals OTHER

Patients will receive routine physiotherapy protocols as well as Non-weightbearing stationary elliptical

Also known as: Cubii Ellipticals

NSLBP treated with Physiotherapy + Sitting ellipticals

Physiotherapy Protocol OTHER

Routine physiotherapy protocol

Also known as: Physiotherapy

NSLBP treated with Physiotherapy; NSLBP treated with Physiotherapy + Sitting ellipticals

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 70 years and CLBP (\>12 wk) located between the costal margins and inferior gluteal folds.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Fitness Cubed Inc.: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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.

  PMID: 10470716 BACKGROUND

• 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: 18164449 BACKGROUND

• 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: 16550447 BACKGROUND

• 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: 27745712 BACKGROUND

• 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: 24994051 BACKGROUND

• 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: 18801686 BACKGROUND

• 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: 26256495 BACKGROUND

• 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: 15867409 BACKGROUND

• 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: 31666220 BACKGROUND

• 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.

  PMID: 23615384 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11074683 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No groups will be masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Foot and Ankle Research and Innovation Laboratory

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 13, 2023
• Study Start: September 18, 2023
• Primary Completion: September 22, 2024
• Study Completion: December 22, 2024
• Last Updated: January 7, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)