NCT06594731

Brief Summary

The purpose of this project is to investigate the feasibility of using belt squat as an exercise intervention for people with chronic low back pain. We will recruit people with chronic low back pain as well as asymptomatic controls

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 3, 2024

Last Update Submit

September 10, 2024

Conditions

Low Back Pain

Keywords

Feasibility study

Outcome Measures

Primary Outcomes (4)

  • Acceptability

    Acceptability of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was acceptable or not.

    Immediately after the intervention

  • Demand

    Demand of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the participants wish to incorporate belt squats into their future training.

    Immediately after the intervention

  • Implementation

    Implementation of the intervention will be assessed using a 5 point likert scale ranging from completely agree to completely disagree on whether the intervention was feasible or not.

    Immediately after the intervention

  • Practicality

    Practicality will be assessed by evaluation of the adherence level, computed as the percentage of completed training sessions.

    Immediately after the intervention

Secondary Outcomes (8)

  • Pain sensitivity

    Assessed at baseline and immediately after the intervention period

  • Muscle strength

    Assessed at baseline and immediately after the intervention period

  • Lumbar flexibility

    Assessed at baseline and immediately after the intervention period

  • Muscle activity

    Assessed at baseline and immediately after the intervention period

  • Oswetry Disability index

    Assessed at baseline and immediately after the intervention period

  • +3 more secondary outcomes

Study Arms (2)

Low back pain patients

EXPERIMENTAL

Low back pain subjects performing hip belt squat training twice per week for 6 weeks.

Other: Hip belt squat training

Healthy individuals

ACTIVE COMPARATOR

Healthy individuals performing hip belt squat training twice per week for 6 weeks.

Other: Hip belt squat training

Interventions

Hip belt squat trainingOTHER

Hip belt squat training performed twice per week for 6 weeks

Healthy individualsLow back pain patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women
  • Men and women with non-specific low back pain for more than twelve weeks

You may not qualify if:

  • Leg pain greater than back pain
  • Neuromuscular disorders
  • Spinal or lower extremity fractures
  • Infections
  • Cancer
  • Osteoporosis
  • Dementia
  • Current substance abuse
  • Former lumbar surgery
  • Persistent pain syndromes other than back pain
  • Inflammatory rheumatic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 19, 2024

Study Start

March 1, 2024

Primary Completion

June 15, 2024

Study Completion

June 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)