Clinical trial NCT04330885: PRE Surgery reHABilitation for Spinal Stenosis
Official title: PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Rehabilitation
Physiotherapy
Keywords: prehabilitation
spinal stenosis
physiotherapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study with two treatment arms; one with care as usual and the intervention group with prehab before surgery. This is a feasibility study to determine how many subjects who need to be included to be able to a obtain an estimate of variance in an outcome when an important difference between groups
Primary purpose: TREATMENT

Brief summary: Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60. LSS is the most common reason to perform spinal surgery for people aged \>65 years and have been shown to be superior to conservative treatment. Hitherto, studies on lumbar spinal stenosis are sparse with only 3 trials including approximately 300 patients. There is also a paucity in studies investigating if people with lumbar spinal stenosis improve their outcome following surgery undergoing a pre-surgery rehabilitation programme including physical fitness exercises, abdominal and back muscle strengthening and a core control approach.

Detailed description: Lumbar spinal stenosis is a spinal disorder that affects mainly people over the age of 60. This age group with neurogenic claudication is expected to rise dramatically over the next 20 years when an estimated 23-25 % of the population will be \> 60 years. Lumbar spinal stenosis is the most common reason to perform spinal surgery for people aged \>65 years and have been shown to be superior to conservative treatment. Conservative treatment post-operatively have recently been described in a Cochrane review to be of importance. Hitherto, studies on lumbar spinal stenosisare sparse with only 3 trials including approximately 300 patients. There is also a paucity in studies investigating if people with lumbar spinal stenosis improve their outcome following surgery undergoing a pre-surgery rehabilitation programme including physical fitness exercises, abdominal and back muscle strengthening and a core control approach.

Aim: The aim of the current study was to evaluate a pre-surgery rehabilitation intervention for patients diagnosed with lumbar spinal stenosis found eligible for a decompression surgery. A further aim was to conduct a qualitative study to explore the experience of symptoms in relation to all-day-living and quality of life among those who have undergone a decompression surgery for lumbar spinal stenosis.

Methods: Patients consecutively seeking or referred for orthopaedic surgery at Spine Clinic in Stockholm will, if found eligible and given their informed consent be randomized into two separate groups following a consultant visit to an orthopaedic surgeon; 1) A pre-habilitation program of 8 weeks before decompression surgery 2) Care as usual, that is information from physiotherapists 2 weeks before surgery and the advice to stay active. Those eligible for decompression surgery are patients aged 50-75 with pseudo-claudication in one or both legs and back pain (VAS\>30), magnetic resonance camera with 1-2 adjacent stenotic segments (L3-S1) (area ≤75mm2), duration of symptoms \>6 months.

Both written and oral information of the study will be given and the patients will give their written consent. An independent physiotherapist blinded to patient assignment will sequentially number the envelopes containing intervention assignments according to a computer-generated randomization. Opaque and sealed envelopes will be opened in front of the participants at the end of the initial assessment visit. The main applicant will be responsible for data collection, to set up the program and educate included physiotherapists, to be responsible for analyses of data and for ethical application.

For the secondary aim a strategic sample of patients from both groups following the surgery will be included to conduct semi-structured deep interviews to explore their experience of facilitators and barriers to every day life both before and after the surgery. The interviews will take place 3 months following the surgery. The collected data will be analysed according a content analysis with categories, sub categories and themes.

Eligibility criteria: Inclusion Criteria:

* Spinal stenosis
* Eligible for decompression surgery
* aged 50-75 years
* pseudo-claudication in one or both legs
* back pain (VAS\>30),
* MRI with 1-2 adjacent stenotic segments (L3-S1) (area ≤75mm2),
* duration of symptoms \>6 months.

Primary outcomes:
measure: Change of Pain level: Numeric pain rating scale 0-11
timeFrame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
measure: Change of Disability level
timeFrame: 6 weeks pre-surgery, pre surgery, 3 and 12 months after surgery
Secondary outcomes:
measure: Change of Fear of movement
timeFrame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
measure: Change of Self efficacy: Self efficacy scale 0-64
timeFrame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
measure: Change of General Health higher value means better health
timeFrame: 6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better health
Other outcomes:
measure: Global Change on a Likert Scale 5 point scale from not changed at all to changed fully
timeFrame: 12 months after surgery
measure: Change of 6 minutes walk test Longer distance means better outcome.
timeFrame: 6 weeks pre-surgery, pre -surgery, 3 and 12 months after surgery
Locations:
city: Stockholm
country: Sweden
facility: Ryggkirurgiskt Centrum
Study officials:
affiliation: Karolinska Institutet
name: Eva Rasmussen Barr, PhD
role: PRINCIPAL_INVESTIGATOR
References: