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Completed

NCT Number: NCT04330885

PRE Surgery reHABilitation for Spinal Stenosis

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ryggkirurgiskt Centrum

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised abdominal exercises and stationary biking

Other

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

Other names: Explain pain

Primary outcomes

  1. Change of Pain level: Numeric pain rating scale 0-11

    Time frame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

    Numeric pain rating scale 0-10, higher value means more pain

  2. Change of Disability level

    Time frame: 6 weeks pre-surgery, pre surgery, 3 and 12 months after surgery

    Oswestry Disability Index 0-100, higher value means more functional limitations

Secondary outcomes

  1. Change of Fear of movement

    Time frame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

    Fear Avoidance Belief Questionnaire physical activity 0-25, higher score indiactes higher fear

  2. Change of Self efficacy: Self efficacy scale 0-64

    Time frame: 6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

    Self efficacy scale for physical activity in low-back pain,higher value indicates a better self-efficacy

  3. Change of General Health higher value means better health

    Time frame: 6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better health

    EuroQol-5 Dimensions Index (EQ5D), 3-point adjectival scale

Other outcomes

  1. Global Change on a Likert Scale 5 point scale from not changed at all to changed fully

    Time frame: 12 months after surgery

    Global recovery, Question to value the overall change of symtoms, measured with Likert scale of 5 steps. HIgher value means better global recovery

  2. Change of 6 minutes walk test Longer distance means better outcome.

    Time frame: 6 weeks pre-surgery, pre -surgery, 3 and 12 months after surgery

    Walk test - , assessed distance managed on 6 minutes, self chosen pace

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis

Acronym: PreShab

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 2, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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