Vertical Climbing (CLMBR) Exercise for Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483608
• Other study ID #: GCO 21-1568
• Status: Completed
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: November 12, 2023

Study information

• Verified date: December 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 12, 2023
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• Vertical climbing ergometer exercise
Exercise using the CLMBR, a vertical climbing exercise ergometer.
• Recumbent cycling
Exercise using a recumbent cycle ergometer

Locations

Country	Name	City	State
United States	Mount Sinai Union Square	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Incidence of adverse events	8 Weeks
Primary	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.	8 Weeks
Primary	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.	Baseline and 8 Weeks
Secondary	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).	8 weeks
Secondary	Minutes of exercise completed	Minutes of exercise completed during the exercise sessions.	8 weeks
Secondary	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.	Baseline and 8 weeks