Remote Exercise Programs in Chronic Low Back Pain

NCT05082649 | Completed DMC

• 1 other identifier: KA-21024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is a common problem that affects many people at some point in their lives. These people constitute a big part of the disease burden due to their recurrent complaints. About 45% of individuals with chronic low back pain seek medical attention. This situation makes chronic low back pain the second reason for individuals to apply to the hospital. Exercise therapy is the first option that comes to mind in the management of low back pain. It is seen that exercise therapy both reduces the intensity of pain and reduces the recurrence rate of complaints. When the literature is examined, it is observed that among the exercise models, stabilization exercises can provide more benefits than general exercises in reducing pain and improving disability. The COVID-19 pandemic causes disruptions in face-to-face rehabilitation services. The development of telemedicine and telerehabilitation services, whose popularity is increasing with the advancing technology, gained momentum with these disruptions. With telerehabilitation, long-term treatments tailored to the needs of the patients can be offered, the cost is low, and the patients can exercise at home, on their own, at their own pace, whenever they want. These reasons make telerehabilitation stand out especially during the pandemic period. The aim of the study planned in this context is to investigate short and long-term results of remote and face-to-face exercise training on function and disease symptoms for individuals with chronic low back pain.

Conditions

Low Back Pain

Keywords

spinal stabilization exercise; tele-rehabilitation; low back pain

Outcome Measures

Primary Outcomes (6)

• Evaluation of Trunk Range of Motion

  Trunk range of motion measurement is a frequently used method in the evaluation of individuals with low back pain. Trunk range of motion measurements will be carried out before and after the exercise program using Valedo® system (Hocoma, Switzerland). Valedo® system is a professional system used in the evaluation and treatment of low back pain and valid and reliable system that is routinely used in the evaluation of trunk range of motion. Within the scope of our study, trunk flexion, extension, lateral flexion and rotation movements will be evaluated. All angles will be measured in degrees.

  15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline trunk range of motion at 8 weeks and 6th months

• Evaluation of Gait Parameters - Time Characteristics 1

  Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step time, gait cycle, and cadance will be evaluated and results will be recorded in seconds.

  15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months

• Evaluation of Gait Parameters - Time Characteristics 2

  Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, stance phase, swing phase, single support, double support, load response and pre-swing will be evaluated and results will be recorded as percentages.

  15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months

• Evaluation of Gait Parameters - Distance Characteristics

  Gait analyses is used to evaluate the time-distance gait parameters in chronic conditions such as low back pain. Gait analyses measurements will be carried out before and after the exercise program using OPTOGait (OPTOGait, Microgate, İtalya, 2010). The OPTOGait system consists of two bars, each 1 meter, and one a sender and the other a receiver unit. It is a portable platform that can be placed on the treadmill. Its validity and reliability have been established. During the assessment, individuals will walk in comfortable clothes and sneakers. Individuals' walking at the pace they choose will be recorded for 1 minute. Within the scope of our study, step length and stride length will be evaluated and results will be recorded in centimeter.

  15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline time-distance gait parameters at 8 weeks and 6th months

• Evaluation of Functional Capacity Level

  Functional capacity level will be evaluated with The Back Performance Scale. This scale is a test that evaluates the effectiveness of each activity that includes 5 different activities (socks test, gathering test, righting test, fingertip-floor test, carrying test). The Back Performance Scale test is scored between 0-15 points. A high score means poor functional capacity.

  10 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline functional capacity level at 8 weeks and 6th months

• Evaluation of Pain Intensity

  Pain intensity will be evaluated with Visual Analog Scale (VAS). The VAS consists of a 10cm line. The pain experienced by the patient is marked as "0: I have no pain", "10: I have a lot of pain". Scoring is based on measuring the level marked by the participant on the line with a ruler.

  5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline pain intensity level at 8 weeks and 6th months

Secondary Outcomes (5)

• Evaluation of Quality of Life

  5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline quality of life at 8 weeks and 6th months

• Evaluation of Exercise Adaptation

  5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline exercise adaptation at 8 weeks and 6th months

• Evaluation of Pain Catastrophization

  5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline pain catastrophizing scale score at 8 weeks and 6th months

• Evaluation of Disability

  5 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline ODI score at 8 weeks and 6th months

• Evaluation of Media and Social Media Usage Situations with Technological Tools

  15 minutes, through study completion, an average of 8 weeks, and 6th months after treatment, change from baseline score at 8 weeks and 6th months

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Remotely (with video) progressive spinal stabilization exercises.

Other: Telerehabilitation

Face to Face Exercises

ACTIVE COMPARATOR

Face to face (in clinic) progressive spinal stabilization exercises.

Other: Face to Face Exercise

Interventions

Face to Face Exercise OTHER

Face to face (in clinic) progressive spinal stabilization exercises.

Face to Face Exercises

Telerehabilitation OTHER

Remotely (with video) progressive spinal stabilization exercises.

Telerehabilitation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Having low back pain for more than 3 months,
• Pain intensity of 3 or more according to VAS,
• literate,
• A smartphone user,
• Own a smartphone
• Individuals who are able to understand the exercises (total score \>21 on the Montreal Cognitive Assessment Scale (MOCA)) will be included in the study.

You may not qualify if:

• Those who have been diagnosed with cervical or lumbar region pathologies,
• Cervical rapiculopathy, thoracic outlet syndrome,
• Having a malignant condition,
• Having systemic diseases such as neurological, psychological, cardiovascular, rheumatological and loss of function due to these diseases,
• History of previous surgery on the spine and upper extremity,
• Acute infection,
• Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: October 19, 2021
• Study Start: November 1, 2021
• Primary Completion: January 5, 2023
• Study Completion: July 5, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

TU (1)