Exercise Types for Low Back Pain

Overseen By Luciana Macedo, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Nerve root compromise, Serious pathology, Pregnancy, Surgery, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

425 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Graded activity, Motor Control Exercises for low back pain?

Research shows that active therapies, including exercises that focus on motor control and stabilization, can improve pain and reduce disability in people with chronic low back pain. These exercises help strengthen back muscles and improve their function, which can lead to less pain and better movement. ^{1 2 3 4 5}

Is exercise safe for treating low back pain?

A study on a walking intervention for back pain looked at the range and severity of adverse events, suggesting that safety is considered in such treatments. However, specific safety data for exercises like graded activity or motor control exercises wasn't detailed in the available research. ^{2 6 7 8 9}

How is the treatment of Graded Activity and Motor Control Exercises unique for low back pain?

Graded Activity and Motor Control Exercises focus on improving the coordination and control of muscles around the spine, which can help reduce pain and disability in people with low back pain. This approach is different from other treatments because it specifically targets the way muscles work together to support the back, rather than just strengthening or stretching them. ^{1 10 11 12 13}

What is the purpose of this trial?

Exercise therapy is the most recommended treatment for chronic low back pain. There is a wide range of exercises available and research studies have shown that no exercise is superior to another. The problem is that the effects of exercise in reducing pain and disability are small to moderate. Researchers and clinicians believe that different patients may best respond to different types of exercises. This means that if patients could be better matched to specific exercises, then the effects of exercise would be greater. A study conducted by the investigators of this study tested whether patient's characteristics could predict outcomes to two of the most common exercises for low back pain: motor control exercises or graded activity. The results showed that a simple questionnaire (Lumbar Spine Instability Questionnaire) could identify patients who responded best to either exercise. Patients with low clinical instability (measured by the questionnaire) responded best to graded activity. Patients with high clinical instability responded best to motor control exercises.These results were the first to show that better matching patients to specific exercises improves outcomes. Although these results have the potential to significantly improve the delivery of exercises for low back pain, validation of the results in a high-quality study with a large group of patients is a prerequisite to clinical implementation. The aim of this study is to conduct a randomized controlled trial comparing the effects of graded activity to motor control exercises and identify groups of respondents to these exercises. The study will also include the evaluation the costs and benefits of these interventions and the potential impact of matched treatment to patients and the health care system. The results of this study has the potential to increase the effects of exercise in low back pain and consequently lead to better patient outcomes and decreased health related costs.

Research Team

Luciana Macedo, PhD

Principal Investigator

McMaster University

Eligibility Criteria

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.

Inclusion Criteria

I speak English and can communicate with my healthcare team.

I have had lower back pain for more than 3 months, with or without leg pain.

My main health issue is back pain.

Exclusion Criteria

Clinical assessment indicating that the participant is not suitable for active exercises (by a family physician, or using the Physical Activity Readiness Questionnaire)

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

You have trouble remembering things or understanding instructions, like someone with dementia or Alzheimer's.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either motor control exercises or graded activity over an 8-week period

8 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 2, 6, and 12 months

Treatment Details

Interventions

• Graded activity
• Motor Control Exercises

Trial Overview 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.

Participant Groups

Group I: Motor Control Exercise Experimental Treatment 1 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 Activity Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

The University of Queensland

Collaborator

Trials

149

Recruited

71,700+

Laval University

Collaborator

Trials

439

Recruited

178,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Macquarie University, Australia

Collaborator

Trials

27

Recruited

27,100+

Findings from Research

In a 12-month study involving 229 participants with chronic back pain, those in a pedometer-based walking intervention reported a higher number of adverse events (350) compared to the usual care group (250), with musculoskeletal injuries being the most common.

Despite the increased reporting of musculoskeletal events, the study concludes that individuals with chronic back pain can safely participate in walking programs, suggesting the need for counseling on injury prevention and gradual increases in activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events experienced by participants in a back pain walking intervention: A descriptive study. Krein, SL., Abdul-Wahab, Y., Kadri, R., et al.[2016]

A systematic review of 582 clinical trials on exercise interventions for low back pain revealed that the reporting quality was generally poor, with a median completeness of only 59.2% for the TIDieR checklist and 33.3% for the CERT checklist.

Despite the introduction of standardized reporting checklists, there has been no significant improvement in the quality of reporting over time, indicating a need for more focused efforts to enhance the clarity and completeness of exercise intervention descriptions in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise interventions for low back pain are poorly reported: a systematic review. Davidson, SRE., Kamper, SJ., Haskins, R., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association Between Clinical Tests Related to Motor Control Dysfunction and Changes in Pain and Disability After Lumbar Stabilization Exercises in Individuals With Chronic Low Back Pain. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Active therapy for chronic low back pain part 1. Effects on back muscle activation, fatigability, and strength. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

The efficacy of active rehabilitation in chronic low back pain. Effect on pain intensity, self-experienced disability, and lumbar fatigability. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Cross-Sectional Study Assessing Treatment Preference of People With Chronic Low Back Pain. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Lumbar multifidus muscle thickness does not predict patients with low back pain who improve with trunk stabilization exercises. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events experienced by participants in a back pain walking intervention: A descriptive study. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

What Modifies the Effect of an Exercise Treatment for Chronic Low Back Pain? A Meta-epidemiologic Regression Analysis of Risk of Bias and Comparative Effectiveness. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Exercise interventions for low back pain are poorly reported: a systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Active therapy for chronic low back pain: part 2. Effects on paraspinal muscle cross-sectional area, fiber type size, and distribution. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Motor Control Exercises in Patients With Chronic Nonspecific Low Back Pain: A Systematic Review and Meta-Analysis. [2023]

11. Japan pubmed.ncbi.nlm.nih.gov

Effect of Interventions for Improving Lumbar Motor Control on Low Back Pain in Sedentary Office Workers: A Randomized Controlled Trials. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Motor control exercise for persistent, nonspecific low back pain: a systematic review. [2022]