Efficacy of Hip Belt Squat Training on Pain Management and Physcial Function in Low Back Pain Patients

NCT06833346 | Not Yet Recruiting

• 1 other identifier: N-20230063-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to investigate the efficacy of the hip belt squat exercise in pain management and physical function for people with chronic low back pain.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (6)

• Oswetry Disability index

  A questionnaire measuring the degree of disability, which ranges from 0 (no disability) to 100 (bedridden).

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Health related quality of life

  A questionnaire measuring the easured health-related quality of life (EuroQOL-5D), ranging from -0.596 to 1, with higher scores indicating better quality of life.

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Fear-avoidance Beliefs Questionnaire

  Fear-avoidance Beliefs Questionnaire (FABQ) measuring the amount of kinesiophobia, ranging from 0-96 with higher scores indicating higher levels of fear avoidance belief.

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• STarTBack tool

  A questionnaire used to assess the risk of chronicity in low back pain (ranging from low to medium to high risk).

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Pain sensitivity

  Pressure-pain threshold was assessed using a handheld pressure algometer.

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Pain intensity

  Patients were asked to rate the intensity of their LBP on a visual analog scale (VAS) using a 10 cm long line, where the far-left part of the line (0/10) corresponded to no pain and the far right part (10/10) corresponded to the worst imaginable pain. Ratings on the VAS scale was gathered both while the participants stood in an upright position and during a self-chosen movement known to induce pain (e.g. bending over).

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

Secondary Outcomes (6)

• Muscle strength

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Lumbar flexibility

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Body composition

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Physical activity level

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

• Tobacco use

  Assessed at baseline, after 6 weeks, 12 weeks, and at 1-year followup

Study Arms (2)

Control

NO INTERVENTION

Low back pain patients not performing an intervention

Hip belt squat exercise

EXPERIMENTAL

Low back pain patients performing hip belt squat training twice per week for 12 weeks.

Other: Hip belt squat exercise

Interventions

Hip belt squat exercise OTHER

Hip belt squat exercise performed twice per week for 12 weeks

Hip belt squat exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women with non-specific low back pain for more than twelve weeks, with a VAS score of at least 3, taken as an average of the last week, and ODI\>20

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

Sponsors & Collaborators

• Aalborg University: lead
• Aleris: collaborator

Study Sites (1)

Aalborg University

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mathias Kristiansen, PhD

CONTACT

+4526803461; mvk@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)