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PRE Surgery reHABilitation for Spinal Stenosis

PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04330885
Acronym
PreShab
Enrollment
20
Registered
2020-04-02
Start date
2019-08-01
Completion date
2022-01-14
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Physiotherapy, Rehabilitation

Keywords

prehabilitation, spinal stenosis, physiotherapy

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.

Interventions

OTHERSupervised abdominal exercises and stationary biking

Explain pain to the patients in order to minimize fear of movement

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigator does not take part in data collection. All data collected via web based surveys.

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

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Pain level: Numeric pain rating scale 0-116 weeks pre-surgery, pre-surgery, 3 and 12 months after surgeryNumeric pain rating scale 0-10, higher value means more pain
Change of Disability level6 weeks pre-surgery, pre surgery, 3 and 12 months after surgeryOswestry Disability Index 0-100, higher value means more functional limitations

Secondary

MeasureTime frameDescription
Change of General Health higher value means better health6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better healthEuroQol-5 Dimensions Index (EQ5D), 3-point adjectival scale
Change of Self efficacy: Self efficacy scale 0-646 weeks pre-surgery, pre-surgery, 3 and 12 months after surgerySelf efficacy scale for physical activity in low-back pain,higher value indicates a better self-efficacy
Change of Fear of movement6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgeryFear Avoidance Belief Questionnaire physical activity 0-25, higher score indiactes higher fear

Other

MeasureTime frameDescription
Global Change on a Likert Scale 5 point scale from not changed at all to changed fully12 months after surgeryGlobal recovery, Question to value the overall change of symtoms, measured with Likert scale of 5 steps. HIgher value means better global recovery
Change of 6 minutes walk test Longer distance means better outcome.6 weeks pre-surgery, pre -surgery, 3 and 12 months after surgeryWalk test - , assessed distance managed on 6 minutes, self chosen pace

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026