Francesca Galiano
|
23/06/2022 - Last update 30/12/2022

Frederico de Oliveira Meirelles, Júlio César de Oliveira Muniz Cunha, Elirez Bezerra da Silva | Year 2020

Osteopathic manipulation treatment versus therapeutic exercises in patients with chronic nonspecific low back pain: a randomized, controlled and double-blind study

Pathology:

Non-specific low back pain

Type of study:

Randomized controlled trial

Date of publication of the study’:

2020/May/21

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Purpose of the study

  • Objective: to determine the efficacy of OMT in case of chronic nonspecific  low back pain
  • Measured outcomes:
    • Primary: pain through Visual Analog Scale (VAS) from 0 to 100 mm
    • Secondary: disability through Oswestry Disability Index 2.0 (ODI), fear of movement through Tampa Scale Kinesiophobia (TSK) and depression through Beck Depression Scale (BDS)

Participants

  • Number: 38 people (28 female and 10 male)
  • Criteria of inclusion: age between 30 and 59 years, diagnostic of chronic nonspecific low back pain with intermittent or persistent lumbar pain with intensity greater than 30 mm on VAS for at least 3 months.
  • Criteria of exclusion: fractures or dislocations of the spine, ligament tears, muscle breakdown, skin tears, sacroiliitis, vertebral osteomyelitis, infections, herniated disk with radicular symptoms, radicular disorders, cauda equina syndrome, tumor, visceral referred pain, red flags for low back pain, difference of length between the two lower extremities superior to 20mm.
  • Gruppi di studio: Groups of study: 2 groups obtained by randomization
    • Group 1: OMT, 20 people(16 female and 4 male, mean age 46 years)
    • Group 2: physical exercise, 18 people (12 female and 6 male, mean age 50.1 years)

Interventions and evaluations

 

  • Assessment of pain through VAS, disability through ODI, fear of movement through TSK and depression through BDS at the beginning of the study and after the last intervention
  • Evaluation of the usual level of physical activity through Baecke questionnaire at the beginning of the study
  • 5 weekly sessions of OMT of 30-45 minutes each and 10 sessions of physical exercise twice a week
  • OMT: articulatory and myofascial techniques
  • Physical exercise: therapeutic exercises for low back pain
  • OMT performed by a physiotherapist with a diploma  in osteopathy
  • Physical exercise performed by three physiotherapy students trained and supervised by an experienced physiotherapist
  • People were asked not to undergo physiotherapy, take any medication or follow other treatments during this study
  • During each visit, the practitioner investigated if the person had followed these directions: if not, the person would be excluded from the study

Results

  • Primary outcomes: after the intervention, both groups saw a statistically significant decrease in pain intensity measured with VAS compared to the beginning of the study. The OMT group had a starkly greater decrease compared to the group with physical exercise (-49mm vs -18mm) in a statistically significant manner.
  • Secondaru outcomes: both groups saw a decrease in disability measured by ODI compared to the beginning of the study in a statistically significant manner. The OMT group had a starkly greater statistically significant reduction compared to the group with physical exercise (-10 vs -4).
    With regard to depression, measured through BDS, the groups did not show statistically significant differences, even though at the beginning of the study the OMT group saw a statistically significant decrease of depression.  The same result as depression was obtained in fear of movement, measured through TSK.
  • Further analysis: the decrease of pain was positively correlated, and in a statistically significant way, to the reduction of disability (strong association), of fear of movement (moderate association) and of depression (moderate association).

Discussion

OMT proved to be able to drastically reduce chronic nonspecific low back pain and other related parameters such as disability, fear of movement and depression. On the contrary, physical exercise induced minor effects compared to OMT, or even no effects like in the case of fear of movement and depression. 

The consequences OMT had on pain seem to have positively affected the other outcomes, which highlights the importance of considering both people and pathological conditions from a biopsychosocial point of view. 

The positive effects of OMT could depend on the reduction of muscular tensions and on an improvement of articular mobility, which induced a greater ease of movement, and, therefore, less fear, disability and depression.The authors hope that this study will promote a wider use of osteopathy as this type of treatment is not really expensive and has no side effects.

The review of Osteopedia

By Marco Chiera

Strengths: calculation of sample size (how many people to recruit); the practitioners tried to control if the participants underwent other therapies; OMT compared to physical exercise, a type of therapy usually considered as a first-line therapy in case of low back pain (manual therapies are usually considered additional second-line interventions); “all round” results, from pain to mood; good discussion of past studies with  in line or divergent results compared to the present study. 

Limiti: OMT performed by a physiotherapist, while the physical exercises were performed by students of physiotherapy; in the introduction the reason why it was decided to estimate also the association between chronic low back pain and depression is not well explained; some criteria of exclusion were not necessarily actual  criteria of exclusion (eg, apparently there is no specific correlation between the length of lower extremities and low back pain); lack of follow-ups to see the results in the long term; absence of an appropriate evaluation of the limits of the study; possible side effects were not assessed. 

The hypothesis data analyzed for the calculation of the sample size were not consistent with the results of the study which invalidates the power of the study (the capacity to find an effect that actually exists): even if a calculation of the power was made in retrospective, this practice is considered circular and little informative (that is to say: without a result the power is normally low, with a result the power is normally high).

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