NCT03470753

Brief Summary

Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and randomized within two phases (retention and compliance). Patients will consent to a 2-step study design, with independent randomization for each. The initial step will assess retention based on 4 different exercise prescription strategies. This will be assessed short-term, and then the 2nd step will consist of a second independent randomization to receive different reminder strategies to determine their influence on exercise compliance at home.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable chronic-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

January 12, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

February 7, 2018

Last Update Submit

January 16, 2020

Conditions

Chronic PainCompliance, PatientChronic Low Back PainKnee Pain Chronic

Outcome Measures

Primary Outcomes (2)

  • Performance Assessment Tool

    A locally developed tool designed to meet the needs of assessing both exercise retention and compliance. It will capture the subject's ability to recall the name of an exercise, the prescribed sets and repetitions, and the ability to perform an exercise using a 4-point ordinal scale

    1-month

  • Compliance

    Subjects will be asked to submit self-reported daily compliance logs.

    1-month

Secondary Outcomes (3)

  • Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)

    1-month

  • Patient Acceptable Symptom State (PASS)

    1-month

  • Self-perception on Physical Health and Ability to Return to Work or Full Duty

    1-month

Study Arms (4)

Exercise Amount

ACTIVE COMPARATOR

Phase 1: 2 or 4 exercises.

Other: Number of ExercisesOther: Type of Instruction

Type of instruction

ACTIVE COMPARATOR

Phase 1: Handout on paper versus handout and visual demonstration/performance.

Other: Number of ExercisesOther: Type of Instruction

Delivery Type

ACTIVE COMPARATOR

Phase 2: Handout vs electronic delivery

Other: Delivery TypeOther: Mobile Reminder

Reminder Type

EXPERIMENTAL

Phase 2: Mobile reminders vs no mobile reminders

Other: Delivery TypeOther: Mobile Reminder

Interventions

Number of ExercisesOTHER

Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.

Exercise AmountType of instruction
Type of InstructionOTHER

The type of instruction in phase 1 will be compared: Instruction by providing a handout only vs being instructed by a provider and practiced by the patient with provider feedback.

Exercise AmountType of instruction
Delivery TypeOTHER

In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.

Delivery TypeReminder Type
Mobile ReminderOTHER

A text-message based mobile reminder tool will be utilized to engage with subjects via texting on a daily basis to provide reminders and encouragement to perform their home exercises.

Delivery TypeReminder Type

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee.
  • The current episode for the injury is 6 weeks or greater
  • A home exercise program is appropriate as part of the management plan for their injury on the first day
  • Between the age of 18 and 65 years.
  • Own and utilize a smart phone
  • Read and speak English well enough to interact with the smart phone-based tool.
  • Able and willing to come in for follow-up at 1-month.

You may not qualify if:

  • History of prior surgery to the lower extremities or spine
  • Already receiving or have received treatment for this episode of pain within the past 6 months.
  • Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, malignancy, joint infection, or systemic disease
  • If participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months
  • Exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Related Publications (6)

  • Jordan JL, Holden MA, Mason EE, Foster NE. Interventions to improve adherence to exercise for chronic musculoskeletal pain in adults. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD005956. doi: 10.1002/14651858.CD005956.pub2.

    PMID: 20091582BACKGROUND

  • Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of measures of self-reported adherence to unsupervised home-based rehabilitation exercise programmes, and their psychometric properties. BMJ Open. 2014 Jun 27;4(6):e005044. doi: 10.1136/bmjopen-2014-005044.

    PMID: 24972606BACKGROUND

  • Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.

    PMID: 17909210BACKGROUND

  • Hayden JA, van Tulder MW, Tomlinson G. Systematic review: strategies for using exercise therapy to improve outcomes in chronic low back pain. Ann Intern Med. 2005 May 3;142(9):776-85. doi: 10.7326/0003-4819-142-9-200505030-00014.

    PMID: 15867410BACKGROUND

  • Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.

    PMID: 20163979BACKGROUND

  • Holcomb LS. A Taxonomic Integrative Review of Short Message Service (SMS) Methodology: A Framework for Improved Diabetic Outcomes. J Diabetes Sci Technol. 2015 Apr 30;9(6):1321-6. doi: 10.1177/1932296815585132.

    PMID: 25934517BACKGROUND

MeSH Terms

Conditions

Chronic PainPatient Compliance

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Daniel Rhon, DSc

    Brooke Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

February 7, 2018

First Posted

March 20, 2018

Study Start

January 12, 2018

Primary Completion

June 30, 2019

Study Completion

November 30, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(1)