An Interactive Gaming-based Intervention for Back Pain

NCT02503410 | Terminated Results

• 1 other identifier: 2015-P-000663
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the outcomes of a traditional, exercise-based rehabilitation intervention for chronic low back pain with the outcomes achieved by combining a traditional intervention with adjunct therapy delivered using an interactive gaming-based system for home-based therapy.

Conditions

Non-specific Chronic Low Back Pain

Keywords

lower back; pain

Outcome Measures

Primary Outcomes (4)

• Visual Analogue Pain Scale at 4 Weeks

  Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).

  Change from baseline in Visual Analogue Pain Scale score at 4 weeks

• Visual Analogue Pain Scale at 8 Weeks

  Subjects are asked to indicate their pain level using a visual analog scale, namely they are asked to choose the position on a horizontal line - drawn on a piece of paper - that corresponds to the pain level that they experience. The line is about 10 cm long and is divided into 10 intervals of equal length referred to as units. The minimum value on the scale is zero (meaning no pain). The maximum value on the scale is ten (meaning maximum ever experienced pain).

  Change from baseline in VAS score at 8 weeks

• Pain Frequency at 4 Weeks

  Subjects are asked how many days they experienced low back pain during the week prior to the study visit.

  Change in pain frequency at 4 weeks

• Pain Frequency at 8 Weeks

  Subjects are asked how many days they experienced low back pain during the week prior to the study visit.

  Change in pain frequency at 8 weeks

Secondary Outcomes (4)

• Oswestry Low Back Pain Disability Questionnaire at 4 Weeks

  Change in disability score at 4 weeks

• Oswestry Low Back Pain Disability Questionnaire at 8 Weeks

  Change in disability score at 8 weeks

• SF36 at 4 Weeks

  Change in clinical score at 4 weeks

• SF36 at 8 Weeks

  Change in clinical score at 8 weeks

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Subjects receive physical therapy for low back pain as typically prescribed in the clinic.

Behavioral: Usual care

Interactive gaming

EXPERIMENTAL

Subjects participate in an intervention combining usual care and home-based exercises using the Valedo system.

Behavioral: Interactive gaming

Interventions

Usual care BEHAVIORAL

Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.

Usual care

Interactive gaming BEHAVIORAL

Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.

Interactive gaming

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Back pain subject-rated \> 3 on an 11 point visual-analog scale (0-10), with pain reported for a time \> 6 months
• Able to commit to all study visits
• Low back pain attributable to mechanical etiology as opposed to infectious, neoplastic, or inflammatory causes.
• BMI ≤ 40
• Familiar with tablet use

You may not qualify if:

• Vision or mobility impairment interfering with the performance of the interactive games
• Current or anticipated receipt of payments from Worker's Compensation or other insurance for disability attributed to low back pain
• Additional treatment for back pain during the period of the study, such as acupuncture
• Unresolved musculoskeletal pathology of the lower limbs
• Severe radiculopathic pain
• Alcohol or substance abuse
• Current medication with coumadin or prednisone, chronic use of steroid medications, daily use of narcotic analgesics, or estrogen supplementation, tricyclic anti-depressants (if not on a regular steady dose at least one month prior to enrollment), or any substance that could impair balance.
• Current diagnosis of:
• Balance problems due to vestibular or other neurological impairments.
• Fibromyalgia
• Severe or progressive neurological deficits, including neuromotor impairment
• Any hypercoagulation condition
• Eczema, Psoriasis, or skin infections, and deep vein thrombosis
• Burns or other acute trauma including unhealed bone fractures or open wounds
• Psychiatric illness not well controlled, or current episode of exacerbated major depressive disorder

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital Boston

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paolo Bonato
• Organization: Spaulding Rehabilitation Hospital

pbonato@partners.org

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor is blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 10, 2015
• First Posted: July 21, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)