1 Kagashicage

Activity 13.4 Random Selection Vs Random Assignment In Psychology

Background

Motor control exercises to improve control and coordination of trunk muscles and graded activity under the principles of cognitive-behavioral therapy are 2 commonly used exercise therapies, yet there is little evidence to support the use of one intervention over the other.

Objective

The objective of this study was to compare the effectiveness of motor control exercises and graded activity for patients with chronic nonspecific low back pain.

Design

This study was a prospectively registered randomized controlled trial with outcome assessment and statistical analyses conducted blind to group.

Setting

The study was conducted in primary care settings.

Patients

The participants were 172 patients with chronic (>12 weeks) nonspecific low back pain.

Interventions

Patients were randomly assigned to receive either motor control exercises or graded activity. There was no attempt to subclassify patients to match them to a treatment. Patients in both groups received 14 sessions of individualized, supervised exercise therapy.

Measurements

Primary outcomes were average pain over the previous week (numeric rating scale) and function (Patient-Specific Functional Scale); secondary outcomes were disability (24-item Roland-Morris Disability Questionnaire), global impression of change (Global Perceived Effect Scale), and quality of life (36-Item Short-Form Health Survey questionnaire [SF-36]). Outcome measures were collected at baseline and at 2, 6, and 12 months after intervention.

Results

A linear mixed models analysis showed that there were no significant differences between treatment groups at any of the time points for any of the outcomes studied. For example, the effect for pain at 2 months was 0.0 (−0.7 to 0.8).

Limitations

Clinicians could not be blinded to the interventions.

Conclusion

The results of this study suggest that motor control exercises and graded activity have similar effects for patients with chronic nonspecific low back pain.

Supervised exercise therapies are among the most commonly advocated treatments for chronic nonspecific low back pain.1,2 However, despite the growing number of studies evaluating the effectiveness of exercise interventions, there is still considerable debate with regard to the most appropriate form of exercise.3 Systematic reviews evaluating the effectiveness of exercise therapies commonly conclude that, to date, there is no evidence to support the superiority of one form of exercise over another.3–5

Among the wide variety of supervised exercise therapies available, motor control exercises and graded activity under the principles of cognitive-behavioral therapy are the most popular and promising forms of exercise for patients with chronic low back pain.1,3,6 The primary reason for their popularity is that, unlike some other forms of exercise, each has a specific rationale for its mechanisms of action in addition to evidence of their efficacy from randomized controlled trials and systematic reviews.4,5 For these reasons, many health professionals believe that these 2 forms of exercise may have superior effects compared with other forms of exercise therapy.

Motor control exercises were developed based on the results of laboratory studies demonstrating that individuals with low back pain have impaired control of the deep (eg, transversus abdominis and multifidus) and superficial trunk muscles responsible for maintaining the stability of the spine.7–10 Motor control exercises utilize principles of motor learning to retrain control of the trunk muscles, posture, and movement pattern,11 ultimately leading to a reduction in the levels of pain and disability.

Graded activity exercises were developed based on studies suggesting that cognitive-behavioral aspects, such as the patient's mood and cognition, are important factors associated with delayed recovery from back pain and with increased levels of disability in patients with chronic pain.12–17 This cognitive-behavioral model assumes that disability is determined not only by the underlying pathology, but also by social, cognitive, emotional, and behavioral factors.18 Therefore, graded activity exercises aim to reduce pain and disability by addressing pain-related fear, kinesiophobia, and unhelpful beliefs and behaviors about back pain19 while correcting physical impairments such as reduced endurance, muscle strength, or balance.20

Systematic reviews have suggested that motor control exercise and graded activity are effective in reducing pain and disability in patients with nonspecific low back pain compared with a minimal intervention approach.4,5 However, only one study has directly compared the effectiveness of motor control exercises and graded activity.21 This randomized controlled trial showed no significant differences between groups in relation to pain or disability at 6-, 12-, and 18-month follow-ups; however, the study had more than 22% loss to follow-up in both groups, which decreases confidence in the results. In addition, the trial protocol was not registered or published prior to beginning data collection, and both interventions were administered in a group format that may not be considered an optimal way to implement these interventions.22

Motor control exercises and graded activity are used in clinical practice, although limited information is available to guide clinical decision making. In view of the limitations of the only trial that compared the effectiveness of these 2 interventions, we believed it was imperative to conduct a high-quality randomized controlled trial where the 2 exercise programs could be directly compared in patients with chronic nonspecific low back pain.

Method

Design Overview

This study was a randomized controlled trial where patients received an intervention for approximately 8 weeks, with follow-ups at 2, 6, and 12 months after intervention. This trial was prospectively registered (ACTRN12607000432415), and the protocol has previously been published.23 All patients signed an informed consent form prior to their inclusion into the study.

Setting and Patients

Participants were recruited to the trial by general practitioners in Sydney and Brisbane or drawn from the waiting list of an outpatient physical therapy department from a public hospital in Sydney. Five patients were recruited by one of the investigators, who identified eligible patients who responded to an advertisement for participation in another set of studies of back pain in Brisbane.

Patients were eligible for inclusion if they met all of the following inclusion criteria:

  • chronic nonspecific low back pain (>3 months' duration) with or without leg pain

  • currently seeking care for low back pain

  • between 18 and 80 years of age

  • English speaker (to allow response to the questionnaires and communication with the physical therapist)

  • clinical assessment indicated that the patient was suitable for active exercises

  • expected to continue residing in the Sydney or Brisbane region for the study duration

  • had a score of moderate or greater on question 7 (“How much bodily pain have you had during the past week?”) or question 8 (“During the past week, how much did pain interfere with your normal work, including both work outside the home and housework?”) of the 36-Item Short-Form Health Survey questionnaire (SF-36).24

Exclusion criteria were:

  • known or suspected serious pathology such as nerve root compromise (at least 2 of the following signs: weakness, reflex changes, or sensation loss, associated with the same spinal nerve)

  • previous spinal surgery or scheduled for surgery during trial period

  • comorbid health conditions that would prevent active participation in exercise programs.

We used a “red flag” checklist to screen for serious pathology and the Physical Activity Readiness Questionnaire from the American College of Sports Medicine guidelines25 to screen for comorbid health conditions that would prevent safe participation in exercise.

Randomization and Interventions

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