Author Names
Oliveira Meirelles, F. , Oliveira Muniz Cunha, J.C., Silva, E.B.
Reviewer Name
Allison Hinish, SPT
Reviewer Affiliation(s)
Duke University Doctor of Physical Therapy Division
Paper Abstract
BACKGROUND: Osteopathic manipulation treatment is widely used in the clinical practice in the care of patients with chronic nonspecific low back pain, however, its benefits still seem uncertain.
OBJECTIVE: This study aimed to verify the efficacy of osteopathic manipulation for chronic nonspecific low back pain.
MATERIALS AND METHODS: Forty-two participants with chronic nonspecific low back pain were selected and randomized into two groups: active control group (ACG – n = 19) and osteopathic manipulation treatment group (OMTG – n = 23). Therapeutic exercises were performed with the ACG and osteopathic manipulation techniques with the OMTG. The interventions were carried out over 5 weeks of treatment, totaling 10 treatments for the ACG and 5 for the OMTG. The visual analogue scale (VAS) was used to measure chronic nonspecific low back pain and the Oswestry Disability Index 2.0, Tampa Scale of Kinesiophobia and Beck Depression Inventory were used to measure disability, kinesiophobia and depression, respectively.
RESULTS: The final chronic nonspecific low back pain in both groups was significantly lower than the initial low back pain (p 6 0.01) and the final chronic nonspecific low back pain of the OMTG was significantly lower than that of the ACG (p = 0.001).
CONCLUSION: This study demonstrated that the treatments were effective in both groups. However, the efficacy of the osteopathic manipulation treatment was greater than that of the therapeutic exercises. Keywords: Osteopathy, osteopathic manipulation treatment, chronic nonspecific low back pain
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?
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- Yes
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Cannot Determine, Not Reported, or Not Applicable
- Was there high adherence to the intervention protocols for each treatment group?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- 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?
- Yes
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Yes
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
Both groups had statistically significant improvement in pain rating and functional capacity after treatment, measured by the Visual Analogue Scale and Owestry Disability Index. Two way repeated measures ANOVA and post-hoc analysis found the Osteopathic Manipulation Treatment group had significantly greater improvement in these measures compared to the active control group.
Key Finding #2
Two-way repeated measures ANOVA and post-hoc analysis of both groups showed no significant improvement in scores for depression or kinesiophobia in either group after treatment.
Please provide your summary of the paper
This double-blind randomized controlled sough to examine whether therapeutic exercise based treatment or osteopathic manipulation treatment was better for treating patients with chronic nonspecific low back pain. Study participants 30 to 50 years old with chronic low back pain (greater than 3 months duration) with an intensity rating above 30 mm on the Visual Analogue Scale were randomized into either the active control group (ACG) or osteopathic manipulation treatment group (OMTG). Individuals with low back pain caused by fractures or dislocations of the spine, ligament ruptures, muscle ruptures, skin lacerations, sacroiliitis, vertebral osteomyelitis, infections, disc herniation with radicular symptoms, rheumatic disorders, cauda equina syndrome, tumors, visceral referred pain, red flags, or lower limb discrepancy greater than 20 mm were excluded from the study. After a pre-intervention assessment, the ACG group was given 2 sessions per week for 5 weeks, for a total of 10 treatment sessions. The ACG treatment was provided by physical therapy students with supervision from an experienced physical therapist. The OMTG group underwent 1 treatment session per week for 5 weeks for a total of 5 sessions, provided by a physical therapist with a graduate degree in Osteopathy. 4 variables were assessed: pain, functional level, kinesiophobia, and depression. These were measured pre and post treatment using the Visual Analogue Scale, Owestry Disability Index, Tampa Scale of Kinesiophobia, and Beck Depression Inventory, respectively. Results from these measurements were analyzed using a two-way repeated measures ANOVA and post-hoc analysis. Statistical analysis found that both the ACG and OMTG had significant improvement in functional capacity and pain levels after treatment, but the OMTG had significantly greater improvement than the ACG. While both groups demonstrated some improvement in kinesiophobia and depression levels, neither group had statistically significant results. The ultimate conclusion of this study determined osteopathic manipulation is more effective at treating chronic nonspecific low back pain than therapeutic exercise. There were some limitations to this study that may have influenced outcomes. The first is that treatment in the ACG group was being provided by student physical therapists, whereas the OMTG group was being treated by more skilled physical therapists with additional training. This difference in skill level may have influenced efficacy of treatment. Also, it was stated that treatment protocol in this study was very generalized and techniques used were not specified to only one body region, due to the nonspecific nature of the participants low back pain. More targeted or customized treatment methods in either group may have influenced results. Finally, specific details of what exercises and manipulation techniques were used in treatment were not readily accessible for review. Analysis of exercises treatment techniques would lend itself to be more useful for readers looking for successful treatment options.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This study overall was soundly conducted and the paper provided detailed descriptions of the study design, participant selection, group assignment, etc. The researchers made sure to properly design their study for reliable and internally valid results. The biggest fault lies in the difference in skill level of the physical therapists assigned to treat the therapeutic exercise group compared to the osteopathic manipulation group. While there was an experienced clinician present during the active control group treatment, the session was conducted by
student physical therapists. The lack of experience in treatment may have led to less valid results than if an experienced and skilled clinician was providing therapeutic exercise, like in the osteopathic manipulation group. Despite this fact, the study does demonstrate that osteopathic manipulation produces strong improvements in patients’ perceived pain levels and functional levels. While the results can only be applied to patient with nonspecific low back pain with no known origin, it is still helpful to know that manipulation can be effective for this large patient population. The study also demonstrated that therapeutic exercise alone leads to significant improvements in pain levels and functional ability. This suggests that the therapeutic exercise and osteopathic manipulation when used together could compound to create even greater improvements than either treatment alone. These findings could be used as the basis for future research on combining the two approaches.
