The Effect of Attention Distraction on the Adherence to Exercise, in Chronic Low Back Pain Patients. (PAINLESS)

University of Thessaly

Status: Not yet enrolling

Conditions: Chronic Low Back Pain (CLBP); Distraction Methods; Adherence to Care

Treatments: Other: Stabilisation exercise, resistance exercise and distraction task; Other: stabilisation exercise and resistance exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07192809

20787/25/TFSKTH - 09/07/2025

Details and patient eligibility

About

This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.

Full description

Participants will be stratified based on their level of physical activity according to the International Physical Activity Questionnaire (IPAQ) into:

• Low physical activity
• Moderate physical activity
• High physical activity

They will then be randomly assigned to one of two groups: (1) an experimental group using the attention distraction application during the standard exercise program and (2) a control group following the same standard exercise program without distraction. The intervention will last for 8 weeks, with participants attending three non-supervised sessions per week (total: 24 training sessions). Each session will last approximately 25-30 minutes. Adherence to the exercise program will be monitored through the EARS questionnaire and the distraction application (The total score ranges from 0 to 24, where a higher score reflects better adherence).

The intervention group sessions consist of 5 minute submaximal warm-up followed by 25 minutes of stabilisation and resistance training with exercises focused on strength and stabilisation while using the distraction application. The training will consist of two parts: warming-up and the resistance and stabilisation program. The resistance program will consist of 4 exercises: knee flexion, abdominal crunches, prone superman and leg extension. Each exercise will be performed for 3 sets of 10 repetitions with a rest of 30 sec corresponding to every set , and 1 minute between each exercise. The stabilisation program will consist of 3 exercises: bridge, plank and side plank. Each exercise will be performed for 3 sets of 1 repetition (maximum time) with a rest of 30 sec corresponding to every set and 1 minute between each exercise. Four levels of difficulty will be given for each exercise to allow for progression. Every 2 weeks, there will be a progression that will be achieved by increasing the resistance band tension, by changing the base of support or my modifying the length of resistance level arm.

In the control group they will perform the same exercises without the distraction-based application.

The exercise intensity will be monitored by the researcher, as determined by the patient's ability to complete three sets of 8-12 repetitions for a given exercise and a CR10scale. The progression will be in line with guidelines provided by the American College of Sports Medicine.

Adherence to the program for both groups will be assessed by the Exercise Adherence Rating Scale (EARS - GR).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Chronic non-specific low back pain (≥3 months)
• No physical therapy or structured exercise program in the last 3 months
• Willingness to use the attention distraction application (for the AD-APP group)
• Completion of the International Physical Activity Questionnaire (IPAQ)

Exclusion criteria

• History of spinal surgery
• Neurological conditions affecting movement
• Regular use of pain relief medication within the past two weeks
• Pregnancy
• Severe psychological disorders that may affect compliance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Distraction Group

Experimental group

Description:

Experimental Group: Standard exercise program with Attention Distraction Application (AD-APP) Participants in this group will: * will be familiarized with the exercises on a separete day prior to testing. * Perform exercises while using an application designed to distract attention in order to achieve a cognitive-motor dual task (exercise task and cognitive task). * Follow the program for 8 weeks, attending non-supervised sessions per week. Every two weeks , there will be a progression that will be achieved by increasing the level of difficulty of each exercise. * Adherence to the exercise program will be tracked through digital monitoring within the application. * Stratified into IPAQ categories (low, moderate, high physical activity). Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).

Treatment:

Other: Stabilisation exercise, resistance exercise and distraction task

Control Group

Active Comparator group

Description:

Control Group: Standard exercise program without Attention Distraction Application (AD-APP) Participants in this group will: * will be familiarized with the exercises on a separete day prior to testing. * Perform the same exercises without attention distraction in order to achieve a single task (exercise task). * Follow the program for 8 weeks, attending non-supervised sessions per week. * Adherence to the exercise program will be tracked through EARS-GR. * Stratified into IPAQ categories (low, moderate, high physical activity). Participants will be given special equipment including an elastic tubing load Thera BandTM (Akron, Ohio, USA).

Treatment:

Other: stabilisation exercise and resistance exercises