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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of exercise therapies to determine which reduces low back pain more effectively. Researchers believe that matching individuals to the appropriate exercise type can enhance outcomes. The study compares motor control exercises, which improve spine stability and muscle control, with graded activity, which aims to increase activity levels and address pain-related fears. Individuals experiencing back pain for over three months, considering it their main issue, may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to more personalized and effective treatments for chronic back pain.

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 prior data suggests that these exercise types are safe for low back pain?

Previous studies have shown that exercises focusing on movement control have positive effects for people with long-term low back pain. These exercises help reduce pain and improve mobility, though the improvements may be small. Research indicates that most people find these exercises easy to perform, with no major side effects reported.

Graded activity, another exercise type, has also been studied and found safe. It can reduce time away from work due to back pain and slightly improve pain and movement. Like movement control exercises, graded activity is generally manageable for most people.

Both treatments are forms of exercise therapy and have been used safely in the past for low back pain, with no serious side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for low back pain because they offer a personalized and holistic approach. Motor Control Exercises focus on retraining the spine’s movement and coordination, aiming to strengthen deep trunk muscles and improve posture and breathing, which is quite different from the typical pain relief medications or general physical therapy. Graded Activity, on the other hand, tackles both the physical and psychological aspects of pain by gradually increasing activity levels and addressing factors like fear and anxiety related to movement, using cognitive-behavioral strategies to boost confidence and activity tolerance. These approaches are distinctive because they combine physical rehabilitation with psychological support, offering a more comprehensive treatment for low back pain.

What evidence suggests that this trial's treatments could be effective for low back pain?

This trial will compare two exercise types for low back pain: motor control exercises and graded activity. Research has shown that motor control exercises, which participants in this trial may receive, can reduce pain and improve movement in people with long-term low back pain. These exercises prove more effective than doing nothing or minimal treatments, enhancing movement and muscle control, and making daily activities easier.

Graded activity, another treatment option in this trial, focuses on building strength and endurance with personalized exercises. However, evidence suggests it may not significantly reduce pain or improve function compared to other treatments. Both exercise types aim to help, but motor control exercises have a better track record for improving back pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Luciana Macedo, PhD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816013/

Graded activity for chronic low back pain - PubMed Central - NIH Graded activity aims to improve physical function through functionally focused exercises, including muscle strength, endurance, and balance (Leeuw 2008), while ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16847036/

The Effectiveness of Graded Activity for Low Back Pain in ... Graded activity did not improve pain or functional status clinically significantly. Conclusions: Graded activity was not effective for any of the outcome ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1413355517302812

Effectiveness of graded activity versus physiotherapy in ... The results of this study suggest that graded activity and physiotherapy have similar effects in the medium-term for patients with chronic nonspecific low back ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD015507/abstract

Graded activity for chronic low back pain To assess the benefits and harms of graded activity compared to placebo, sham, or no treatment for pain and function in adults with chronic non‐ ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2794765

Effect of Graded Sensorimotor Retraining on Pain Intensity ... In this randomized clinical trial of patients with chronic low back pain, graded sensorimotor retraining significantly improved pain ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/14734329/

Graded activity for low back pain in occupational health care Conclusions: Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain. Publication types.

7. acpjournals.org acpjournals.org/doi/10.7326/0003-4819-140-2-200401200-00007

Graded Activity for Low Back Pain in Occupational Health ... Conclusions: Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

8. academic.oup.com academic.oup.com/ptj/article/90/6/860/2737764

Graded Activity and Graded Exposure for Persistent ... The available evidence suggests that graded activity in the short term and intermediate term is slightly more effective than a minimal intervention.