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PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol.

Lindbäck Y, Tropp H, Enthoven P, Abbott A, Öberg B - BMC Musculoskelet Disord (2016)

Bottom Line: The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels.Primary outcome measure is Oswestry Disability Index.The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical and Health Sciences, Division of Physiotherapy, Faculty of Health Sciences, Linköping University, SE-58183, Linköping, Sweden.

ABSTRACT

Background: Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes.

Methods: This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary outcome measure is Oswestry Disability Index. Secondary outcome measures are the visual analogue scale for back and leg pain, pain drawing, health related quality of life, Hospital anxiety and depression scale, Fear avoidance beliefs questionnaire, Self-efficacy scale and Work Ability Index.

Discussion: The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.

Trial registration: ClinicalTrials.gov reference: NCT02454400 (Trial registration date: August 31st 2015) and has been registered on ClinicalTrials.gov, identifier: NCT02454400 .

No MeSH data available.


Related in: MedlinePlus

Treatment based classification (TBC) [26–28] used in the trial
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Fig2: Treatment based classification (TBC) [26–28] used in the trial

Mentions: The following TBC will be utilized; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The TBC criteria for patient’s subjective and physical examination findings which has been outlined in previous publications [26–28] will be utilized except for the “Specific exercises” and “Manipulation” classifications in the original TBC being collapsed to one classification named “Specific exercises and mobilization”. This means that manipulation will not be used as a treatment classification. The reason for this is that the patients included in the study have long-lasting pain that does not fulfil the TBC criteria of symptom duration < 16 days for the manipulation classification [27]. Furthermore, literature suggests that 25 % of the patients fulfill criteria for more than one classification and for 68 % of these cases it is the combination of criteria for “Specific exercises” and “Manipulation” [26]. In the “Specific exercise and mobilization” classification, a test for centralization with lumbar spine flexion combined with rotation in side lying position will be added, to assess more directions than only sagittal plane movement. This position is commonly used in clinical practice for assessment and treatment of patients with sciatica. If repeated exercises only give an unstable centralisation, where the pain is reduced or abolished during the repeated movement testing or positioning but after resuming a weight bearing position for one minute, the pain intensity level returned to the pre-testing intensity, patients will be classified to this classification [48]. This added criteria is useful in patients who have significant activity limitation due to pain, are too deconditioned to perform repetitions of tests or are patients who activity limiting symptoms are not painful such as in some spinal stenosis cases. In the PA-test, segmental pain will be documented, but not hypo- or hypermobility, due to lack of reliability in segmental motion restriction [49]. The tests “Active straight leg raising” (ASLR) and Trendelenburg will be added as criteria for the “Motor control exercises” classification [28]. The TBC is outlined in Fig. 2.Fig. 2


PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol.

Lindbäck Y, Tropp H, Enthoven P, Abbott A, Öberg B - BMC Musculoskelet Disord (2016)

Treatment based classification (TBC) [26–28] used in the trial
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4940916&req=5

Fig2: Treatment based classification (TBC) [26–28] used in the trial
Mentions: The following TBC will be utilized; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The TBC criteria for patient’s subjective and physical examination findings which has been outlined in previous publications [26–28] will be utilized except for the “Specific exercises” and “Manipulation” classifications in the original TBC being collapsed to one classification named “Specific exercises and mobilization”. This means that manipulation will not be used as a treatment classification. The reason for this is that the patients included in the study have long-lasting pain that does not fulfil the TBC criteria of symptom duration < 16 days for the manipulation classification [27]. Furthermore, literature suggests that 25 % of the patients fulfill criteria for more than one classification and for 68 % of these cases it is the combination of criteria for “Specific exercises” and “Manipulation” [26]. In the “Specific exercise and mobilization” classification, a test for centralization with lumbar spine flexion combined with rotation in side lying position will be added, to assess more directions than only sagittal plane movement. This position is commonly used in clinical practice for assessment and treatment of patients with sciatica. If repeated exercises only give an unstable centralisation, where the pain is reduced or abolished during the repeated movement testing or positioning but after resuming a weight bearing position for one minute, the pain intensity level returned to the pre-testing intensity, patients will be classified to this classification [48]. This added criteria is useful in patients who have significant activity limitation due to pain, are too deconditioned to perform repetitions of tests or are patients who activity limiting symptoms are not painful such as in some spinal stenosis cases. In the PA-test, segmental pain will be documented, but not hypo- or hypermobility, due to lack of reliability in segmental motion restriction [49]. The tests “Active straight leg raising” (ASLR) and Trendelenburg will be added as criteria for the “Motor control exercises” classification [28]. The TBC is outlined in Fig. 2.Fig. 2

Bottom Line: The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels.Primary outcome measure is Oswestry Disability Index.The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical and Health Sciences, Division of Physiotherapy, Faculty of Health Sciences, Linköping University, SE-58183, Linköping, Sweden.

ABSTRACT

Background: Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes.

Methods: This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary outcome measure is Oswestry Disability Index. Secondary outcome measures are the visual analogue scale for back and leg pain, pain drawing, health related quality of life, Hospital anxiety and depression scale, Fear avoidance beliefs questionnaire, Self-efficacy scale and Work Ability Index.

Discussion: The study findings will help improve the treatment of patients with degenerative lumbar spine disorder scheduled for surgery.

Trial registration: ClinicalTrials.gov reference: NCT02454400 (Trial registration date: August 31st 2015) and has been registered on ClinicalTrials.gov, identifier: NCT02454400 .

No MeSH data available.


Related in: MedlinePlus