Trial Outcomes & Findings for Thera-Band® HEP for LBP Secondary Prevention (NCT NCT02355275)

Results Overview

Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

4 weeks

Results posted on

2016-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Home Exercise Program Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
Overall Study STARTED	22
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thera-Band® HEP for LBP Secondary Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Home Exercise Program n=22 Participants Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
Age, Continuous	41.5 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Patient disability was measured using the Oswestry Disability Index (OSW), a self-report outcome measure. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. The score is calculated by totaling the values marked, divided by 50 x 100. The greater the score the greater the disability. For example, 0% to 20% would be minimal disability and 81%-100% would be bed-bound. This outcome measure was reported at baseline (T1) and 4 weeks later (T2).

Outcome measures

Outcome measures
Measure	Home Exercise Program n=22 Participants Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
Oswestry Disability Index OSW T1	18.75 units on a scale Interval 2.0 to 34.0
Oswestry Disability Index OSW T2	14.71 units on a scale Interval 4.0 to 42.0

SECONDARY outcome

Timeframe: 4 weeks

The Numeric Pain Rating Scale (NPRS) is a self-report scale measuring pain. It is measured from 0 to 10, 0 being pain free and 10 being the worse imaginable pain. This was measured at baseline (T1) and 4 weeks (T2)

Outcome measures

Outcome measures
Measure	Home Exercise Program n=22 Participants Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
Numeric Pain Rating Scale Pain T1	2.7 units on a scale Interval 0.0 to 7.0
Numeric Pain Rating Scale Pain T2	2.3 units on a scale Interval 1.0 to 7.0

Adverse Events

Home Exercise Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jena Slaski

Sport & Spine Rehab Clinical Research Foundation

Phone: 301-251-2777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place