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Exercise Types for Low Back Pain

N/A

Recruiting

Led By Luciana G Macedo, PhD

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between 18 to 80 years of age

Back pain being the primary musculoskeletal complaint of the patient

Must not have

Nerve root compromise (2 strength, reflex or sensation affected for the same nerve root)

Severe neuromuscular condition (e.g. spinal cord injury) that precludes participant from engaging in activity exercise

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 2, 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether patients with chronic low back pain respond better to two different types of exercise: motor control exercises or graded activity. The results of the study could improve the delivery of exercises for low back pain and lead to better patient outcomes.

Who is the study for?

This trial is for adults aged 18-80 with chronic low back pain lasting more than 3 months, who primarily complain of back pain and can speak English. They should have moderate to severe pain or disability and be suitable for physiotherapy as indicated by the STarT Back Tool.

What is being tested?

The study compares two exercise treatments for chronic low back pain: graded activity and motor control exercises. It aims to see which exercise works best depending on the patient's characteristics, potentially improving treatment outcomes and reducing healthcare costs.

What are the potential side effects?

Exercise interventions like graded activity or motor control exercises may cause temporary muscle soreness or discomfort, especially when starting a new program or increasing intensity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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My main health issue is back pain.

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I experience moderate to severe pain or disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have weakness, altered reflexes, or sensation loss due to nerve damage.

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I have a severe condition like a spinal cord injury that stops me from exercising.

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I might have a serious health issue like an infection, fracture, cancer, or severe arthritis.

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I am scheduled for or on a wait list for surgery during the trial period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 2, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 2, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 2, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Oswestry Disability Index

Secondary study objectives

EQ-5D-5L

IMPACT of low back pain - PROMIS-9

Pain Numeric Ranting Scale

+1 more

Other study objectives

Effect Modifier: Coping strategies questionnaire

Effect Modifier: OREBRO LBP screening questionnaire

Effect Modifier: Pain Pressure Threshold Assessment

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Motor Control ExerciseExperimental Treatment1 Intervention

The primary goal of motor control exercises is to retrain optimal control and coordination of the spine. It uses principles of motor learning such as segmentation, simplification and task-specific practice to retrain control of trunk muscles activation, alignment and movement. The first stage of the treatment involves assessment of the postures, movement patterns and muscle activation associated with symptoms and a retraining program designed to improve activity of muscles assessed to have poor control (usually the deep trunk muscles). Participants are taught how to contract these muscles independently. During this stage additional exercises for breathing control, posture of spine and movement are performed. The second stage of the treatment involves the progression of the exercises towards functional activities, firstly using static then dynamic tasks. Education is also included.

Group II: Graded ActivityExperimental Treatment1 Intervention

The primary goal of graded activity is to address individual modifiable contextual factors associated with the pain experience such as self-efficacy, pain-related fear, kinesiophobia and unhelpful beliefs/behaviors about back pain while at the same time addressing physical impairments such as endurance, muscle strength and balance. A primary goal of the program is to increase activity tolerance by performing individualized and submaximal exercises in addition to ignoring illness behaviors and reinforcing well behaviors. Activities in the program are progressed in a time-contingent manner from the baseline assessed ability to a target goal set jointly by patient and therapist. Cognitive-behavioral principles are used to help patients overcome the natural anxiety associated with pain and activities.

0 / 7Eligibility criteria met