Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Icahn School of Medicine at Mount Sinai15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low Back Pain

Interventions

Vertical climbing ergometer exerciseOTHER

Exercise using the CLMBR, a vertical climbing exercise ergometer.

Recumbent cyclingOTHER

Exercise using a recumbent cycle ergometer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Mount Sinai Union Square

New York, New York, United States

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: 8 Weeks

Number of completed exercise sessions

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.

Time frame: 8 Weeks

Change in Numeric Pain Rating Scale

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.

Time frame: Baseline and 8 Weeks

Secondary Outcomes

Numeric Pain Rating Scale

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).

Time frame: 8 weeks

Minutes of exercise completed

Minutes of exercise completed during the exercise sessions.

Time frame: 8 weeks

Change in The Oswestry Disability Index

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.

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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