NCT03984864

Preference, Exercise Therapy Adherence and Efficacy Low Back Pain

Status unknown NA Last updated 10 March 2020

What this trial tests

NA trial testing Exercise therapy in Low Back Pain, Recurrent in 50 participants. Status unknown.

Timeline

1 July 2019

Primary endpoint
30 December 2020

30 December 2020

Quick facts

Lead sponsor	Ariel University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 July 2019
Primary completion	30 December 2020
Estimated completion	30 December 2020
Sites	1 location across Israel

Drugs / interventions tested

• Exercise therapy

Conditions studied

• Low Back Pain, Recurrent — all drugs for Low Back Pain, Recurrent →

Sponsor

Ariel University

Who can join

Adults 18 to 35, any sex, with Low Back Pain, Recurrent. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Low back pain, mainly nonspecific (NSLBP) is a major cause of pain and disability worldwide. Exercise therapy (ET) is considered as the first line treatment, and it is one of the treatment modalities most commonly used by physiotherapists. Yet, ET is reliant on the adherence of patients to its various components. Research has demonstrated a positive relationship between adherence to rehabilitation programs and recovery from a variety of musculoskeletal conditions. Therefore, factors that strengthen adherence to ET may increase its efficacy for NSLBP. Converging evidence from recent studies suggest that control and choice may increase adherence to various treatments.

Therefore, the purpose of this study is to evaluate the effect of patient choice and preference on adherence and efficacy of exercise for recovery from NSLBP.

Design: Matched case control study. Participants: Fifty subjects with chronic (\>3 months) NSLBP. Twenty-five participants will be allocated to exercise by preference group, and 25 aged and gender controls will be allocated to exercise group.

Inclusion criteria:

1. Non-specific low back pain (pain or discomfort in the lumbosacral area, with or without symptoms to the lower extremities), diagnosed by general physician or orthopedic surgeon.
2. Age 18-35
3. Chronic pain (greater than 3 months' duration).

Exclusion Criteria:

1. Specific cause for LBP (rheumatic diseases, tumors, fractures, fibromyalgia, previous spinal surgery, pregnancy, low back pain after car or work accidents).
2. Previous (last three years) ET treatment for NSLBP.
3. Regularly performing exercise more than WHO's recommendation:

* 150 minutes of moderate-intensity aerobic physical activity throughout the week or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity.
* Muscle-strengthening activities should be done involving major muscle groups on 2 or more days a week.

Procedure: After initial assessment, participants in the intervention group will be asked to choose 3-4 items from a list of 10 general exercises - intended for treatment of low back pain. Each matched participant in the control group will receive the same exercise (without the option to choose). Participants will be instructed to perform their exercises three times a week, for a period of four weeks (12 sessions total).

Outcomes: Oswestry Disability Index (ODI) Henry-Eckert Performance Assessment Tool (HEPA) Both measurements will be taken on the first and last meeting. Additionally, each participant will fill a personal weekly exercise log (selecting between complete \\ incomplete \\ lack of execution) - sent by e-mail.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.