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Completed

NCT Number: NCT05483608

Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

This is a randomized control trial of vertical climbing ergometer exercise for individuals with chronic low back pain. Using a parallel-arm design, participants will be randomized to 8 weeks of supervised exercise using either the vertical climbing ergometer (CLMBR) or a recumbent cycling ergometer. This feasibility study will examine the safety, tolerability, and efficacy of vertical climbing exercise for individuals with chronic low back pain.

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Key information

Conditions

Chronic Low Back Pain Back Pain Behavior Low Back Pain Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Union Square

New York, 10003, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Confirmed chronic (>12 weeks) low back pain at screening assessment (based on patient history)
  • Ability to comply with the current Mount Sinai Health system COVID-19 requirements for research participants (e.g., vaccination, masks)

Exclusion criteria

  • Criteria will be evaluated during the clinical evaluation at the screening visit. All determinations will be the decision of the study physician:
  • Less than 2/10 low back pain on 0-10 numeric rating scale for average pain over past 7 days at baseline assessment
  • Any cardiovascular or musculoskeletal contraindication to exercise
  • Impaired balance contraindicating exercise
  • Known psychological illnesses or cognitive impairments contraindicating exercise or preventing the ability to complete study assessments
  • Current pregnancy
  • Current medications or new medications commenced that may impact the ability for change to be detected in study
  • Any other contraindication in the opinion of the study physician

Treatment and study plan

Vertical climbing ergometer exercise

Other

Exercise using the CLMBR, a vertical climbing exercise ergometer.

Recumbent cycling

Other

Exercise using a recumbent cycle ergometer

Primary outcomes

  1. Incidence of adverse events

    Time frame: 8 Weeks

    Incidence of adverse events

  2. Number of completed exercise sessions

    Time frame: 8 Weeks

    The number of completed exercise sessions. A completed session is defined as achieving a minimum of 15 minutes of active exercise during a commenced session.

  3. Change in Numeric Pain Rating Scale

    Time frame: Baseline and 8 Weeks

    11-point numerical rating scale evaluating average pain intensity over the past 7 days. A clinically meaningful difference will be considered as 2 points. Change in Numeric Pain Rating scale at 8 weeks as compared to baseline. Full scale from 0-10, with higher score indicating more pain.

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 8 weeks

    Average acute change in pain intensity on 11-point numerical rating scale (higher = worse pain) during or immediately post-exercise, or reported at the beginning of the following session (unless believed that the change in pain was caused by something unrelated to the study intervention).

  2. Minutes of exercise completed

    Time frame: 8 weeks

    Minutes of exercise completed during the exercise sessions.

  3. Change in The Oswestry Disability Index

    Time frame: Baseline and 8 weeks

    The Oswestry Disability Index will be used to evaluate changes in disability in day-to-day activities as a result of low back pain. A clinically meaningful difference will be considered as 10 points. Full scale is 0 (no disability) to 50 (complete disability), higher score indicating poorer health outcomes.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Clinical Trial of Vertical Climbing Ergometer Exercise (CLMBR) in People With Chronic Low Back Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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