Sensorimotor Training in Low-back Pain Rehabilitation

Low Back Pain Clinical Trial

— SeMoPoP  

Official title:

Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304120
• Other study ID #: 2014-0873
• Status: Completed
• Phase: N/A
• First received: November 17, 2014
• Last updated: April 5, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Reha Rheinfelden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics Committee of Northwestern Switzerland
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with musculoskeletal low back pain (non-specific low back pain)

• Age = 18 years

Exclusion Criteria:

• Known or suspected neurological diseases or lesions

• Traumatic injury of musculoskeletal system (fractures, tumours)

• Spinal pathologies (e.g., tumour, infection, fracture, and inflammatory disease)

• Previous spinal surgery

• Presence of any contraindication to exercise (fracture or cardiovascular limitations)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Proprioceptive postural training

• Treadmill training

• Conventional physiotherapy
All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Michael A. McCaskey	University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Scholz JP, Schöner G. The uncontrolled manifold concept: identifying control variables for a functional task. Exp Brain Res. 1999 Jun;126(3):289-306. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of self-reported pain on 100mm Visual Analogue Scale (VAS)		Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)	No
Primary	Change of functional status recorded with the Oswestry Disability Index (ODI)		Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)	No
Secondary	Centre of Pressure	Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)	No
Secondary	Joint Repositioning Error (segmental)	Repositioning acuity after surface perturbation.	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)	No
Secondary	Uncontrolled Manifold Index (UCM)	Segmental joint configuration.	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)	No