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PRE Surgery reHABilitation for Spinal Stenosis (PreShab)

Primary Purpose

Low Back Pain, Rehabilitation, Physiotherapy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Supervised abdominal exercises and stationary biking
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring prehabilitation, spinal stenosis, physiotherapy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ryggkirurgiskt Centrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehab group

Care as usual

Arm Description

The patients in the PREHAB group will meet with a PT for 6 weeks pre surgery. The PT will coach the patient in 1:1 visits with a graded activity program with the purpose to affect fear of movement and raising level of self-efficacy with physical activity. The intervention comprises; cycling on a stationary cycle. Instructions of exercises that strengthen the deep and the superficial abdominal muscles and the back muscles. Information to contract the abdominal muscles in posturally loaded position to support their back. Information on flexion exercises of their lumbar spine and to keep the back in a flexed position when standing and walking (as opposed to extension). Recommendation to use "Nordic walk (stavar)" for outdoor walking

Control group will be treated with care as usual meaning information from a PT two weeks prior to the surgery with information on the surgery and to stay active. Both groups will be given information on to stay active and home exercises following the surgery.

Outcomes

Primary Outcome Measures

Change of Pain level: Numeric pain rating scale 0-11
Numeric pain rating scale 0-10, higher value means more pain
Change of Disability level
Oswestry Disability Index 0-100, higher value means more functional limitations

Secondary Outcome Measures

Change of Fear of movement
Fear Avoidance Belief Questionnaire physical activity 0-25, higher score indiactes higher fear
Change of Self efficacy: Self efficacy scale 0-64
Self efficacy scale for physical activity in low-back pain,higher value indicates a better self-efficacy
Change of General Health higher value means better health
EuroQol-5 Dimensions Index (EQ5D), 3-point adjectival scale

Full Information

First Posted
December 31, 2019
Last Updated
March 13, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT04330885
Brief Title
PRE Surgery reHABilitation for Spinal Stenosis
Acronym
PreShab
Official Title
PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
January 14, 2021 (Actual)
Study Completion Date
January 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Rehabilitation, Physiotherapy
Keywords
prehabilitation, spinal stenosis, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator does not take part in data collection. All data collected via web based surveys.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehab group
Arm Type
Experimental
Arm Description
The patients in the PREHAB group will meet with a PT for 6 weeks pre surgery. The PT will coach the patient in 1:1 visits with a graded activity program with the purpose to affect fear of movement and raising level of self-efficacy with physical activity. The intervention comprises; cycling on a stationary cycle. Instructions of exercises that strengthen the deep and the superficial abdominal muscles and the back muscles. Information to contract the abdominal muscles in posturally loaded position to support their back. Information on flexion exercises of their lumbar spine and to keep the back in a flexed position when standing and walking (as opposed to extension). Recommendation to use "Nordic walk (stavar)" for outdoor walking
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Control group will be treated with care as usual meaning information from a PT two weeks prior to the surgery with information on the surgery and to stay active. Both groups will be given information on to stay active and home exercises following the surgery.
Intervention Type
Other
Intervention Name(s)
Supervised abdominal exercises and stationary biking
Other Intervention Name(s)
Explain pain
Intervention Description
Explain pain to the patients in order to minimize fear of movement
Primary Outcome Measure Information:
Title
Change of Pain level: Numeric pain rating scale 0-11
Description
Numeric pain rating scale 0-10, higher value means more pain
Time Frame
6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
Title
Change of Disability level
Description
Oswestry Disability Index 0-100, higher value means more functional limitations
Time Frame
6 weeks pre-surgery, pre surgery, 3 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Change of Fear of movement
Description
Fear Avoidance Belief Questionnaire physical activity 0-25, higher score indiactes higher fear
Time Frame
6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
Title
Change of Self efficacy: Self efficacy scale 0-64
Description
Self efficacy scale for physical activity in low-back pain,higher value indicates a better self-efficacy
Time Frame
6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
Title
Change of General Health higher value means better health
Description
EuroQol-5 Dimensions Index (EQ5D), 3-point adjectival scale
Time Frame
6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better health
Other Pre-specified Outcome Measures:
Title
Global Change on a Likert Scale 5 point scale from not changed at all to changed fully
Description
Global recovery, Question to value the overall change of symtoms, measured with Likert scale of 5 steps. HIgher value means better global recovery
Time Frame
12 months after surgery
Title
Change of 6 minutes walk test Longer distance means better outcome.
Description
Walk test - , assessed distance managed on 6 minutes, self chosen pace
Time Frame
6 weeks pre-surgery, pre -surgery, 3 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Rasmussen Barr, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryggkirurgiskt Centrum
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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PRE Surgery reHABilitation for Spinal Stenosis

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