The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial – Duke Center of Excellence in Manual and Manipulative Therapy

Author Names

Saracoglu, I., Isintas, A.M., Afsar, E., Gokpinar, H.H.

Reviewer Name

Abigail Tolstyka, SPT

Reviewer Affiliation(s)

Duke University Doctor of Physical Therapy Division

Paper Abstract

Objectives: The aim of this study was to investigate the short- and mid-term effects of pain neuroscience education (PNE) combined with manual therapy (MT) and a home exercise program (HEP) on pain intensity, back performance, disability, and kinesiophobia in patients with chronic low back pain (CLBP). Methods: This study was designed as a prospective, randomized, controlled, single-blind study in which 69 participants were randomly assigned to three groups. Participants in Group 1 received PNE, MT, and the HEP, while Group 2 received MT and the HEP. Participants in the control group did the HEP only. All interventions lasted 4 weeks. The participants’ pain intensity, disability, low back performance, and kinesiophobia were assessed. All assessments were executed before intervention, at 4 weeks, and at 12 weeks post-intervention by the same blinded physiotherapist. A mixed model for repeated measures was used for each outcome measure. Results: Analysis of pain level (p < .05), back performance (p < .05), disability (p < .05) and kinesiophobia (p < .05) revealed significant time, group, and time-by-group interaction effects. The participants in Group 1 exhibited greater improvement in terms of pain intensity and kinesiophobia compared to the participants in Group 2 and the control group. Level of disability was significantly decreased in both Group 1 and Group 2 compared to the control group. Conclusion: This study suggests that a multimodal treatment program combining PNE, MT, and HEP is an effective method for improving back performance and reducing pain, disability, and kinesiophobia in the short (4 weeks) and midterm (12 weeks).

NIH Risk of Bias Tool

Quality Assessment of Controlled Intervention Studies

Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT?

Was the method of randomization adequate (i.e., use of randomly generated assignment)?

Was the treatment allocation concealed (so that assignments could not be predicted)?

Were study participants and providers blinded to treatment group assignment?

Were the people assessing the outcomes blinded to the participants’ group assignments?

Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?

Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?

Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?

Was there high adherence to the intervention protocols for each treatment group?

Were other interventions avoided or similar in the groups (e.g., similar background treatments)?

Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?

Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?

Cannot Determine, Not Reported, or Not Applicable

Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?

Cannot Determine, Not Reported, or Not Applicable

Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?

Key Finding #1

A multimodal program including pain neuroscience education (PNE), manual therapy, and home exercise programs to treat chronic LBP improved pain levels, disability, low back performance, and kinesiophobia within 4 weeks of treatment.

Key Finding #2

Combining manual therapy and exercise with cognitive and behavioral approaches may provide greater benefit in patients with chronic low back pain or other chronic pain. The implementation of manual therapy and exercise alone may be inadequate in comparison.

Please provide your summary of the paper

This study aimed to evaluate several factors contributing to low back pain including low back performance, pain intensity, kinesiophobia, and disability to determine the short term effects of a combined treatment approach. Interventions for the chronic low back pain (CLBP) participants in this study consisted of manual therapy, home exercise programs, and pain neuroscience education. There was a total of 69 participants, ages 18-65 years old, split into three different groups. Each participant had experienced CLBP for at least 6 months and reported their pain intensity as 5/10 or higher. The first group received PNE, manual therapy, and home exercise programs. The second group received strictly manual therapy and home exercise programs. Finally, the third group (i.e. control group) only participated in the home exercise programs. The study lasted approximately 4 weeks. Each week, a scheduled PNE session was held for group one participants. These sessions lasted about 40-45 minutes long and were conducted by the same physiotherapist weekly. For groups one and two, manual therapy was given twice per week for 30 minutes each. The joint mobilization techniques for LBP were provided, including low velocity, mid-range, posterior-to-anterior force to the lower lumbar spine in a prone position. As stated previously, all three groups were assigned a home exercise program. This consisted of lumbar and pelvis stretching, as well as strength training interventions. All participants were asked to perform each exercise for ten repetitions, three times per day for four weeks. All three groups were reevaluated at the end of the four weeks of interventions, then again after 12 weeks. The study found that the multimodal program including PNE, manual therapy, and home exercise programs assigned to group one was associated with clinically significant improvements in pain level, disability, low back performance, and kinesiophobia at the 12-week follow-up. Furthermore, group two also showed significant improvements in pain intensity when participating in manual therapy and home exercise programs. The control group, only participating in home exercise programs, showed no clinical improvements at the 12-week follow-up. Limitations in this study included a variation of education levels among the participants and inability to track consistency during home exercise programs. The differing levels of education may have potentially impacted patient’s ability to learn PNE or understand the home exercise program. Along with this, adherence of the home exercise program may have lacked consistency among participants, making it difficult to determine whether the 12-week follow-up was truly accurate. Strengths of this study included similarities among participants in terms of age, body weight, body mass index, or duration of CLBP, no matter the group assigned. With this, all participants in each group had similar baseline scores for pain intensity, back performance, disability, and kinesiophobia.

Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.

In a clinical setting, it is beneficial to implement a well-rounded plan of care to patients with chronic low back pain. By providing pain neuroscience education, physical therapists would adequately incorporate cognitive and behavioral approaches to the patient’s treatment. Common factors that negatively impact patient’s plan of care include stress, anxiety, fear avoidance, and kinesiophobia. Each topic is addressed during PNE via the fear-avoidance model. In addition to education, manual therapy and home exercise programs should be implemented for greater benefits in patients with CLBP or other chronic pain. This multimodal treatment program is associated with significant improvements in pain levels, disability, low back performance, and kinesiophobia, and would be beneficial in an outpatient orthopedic setting for CLBP.