PRE Surgery reHABilitation for Spinal Stenosis (PreShab)

PRE Surgery reHABilitation for Patients Suffering From 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Rehabilitation; Physiotherapy
• Intervention / Treatment: Other: Supervised abdominal exercises and stationary biking

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Ryggkirurgiskt Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prehab group; 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	Other: Supervised abdominal exercises and stationary biking; Explain pain to the patients in order to minimize fear of movement; Other Names: Explain pain
NO_INTERVENTION: Care as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Pain level: Numeric pain rating scale 0-11	Numeric pain rating scale 0-10, higher value means more pain	6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
Change of Disability level	Oswestry Disability Index 0-100, higher value means more functional limitations	6 weeks pre-surgery, pre surgery, 3 and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Fear of movement	Fear Avoidance Belief Questionnaire physical activity 0-25, higher score indiactes higher fear	6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
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	6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery
Change of General Health higher value means better health	EuroQol-5 Dimensions Index (EQ5D), 3-point adjectival scale	6 weeks before surgery, pre surgery, 3 and 12 months after surgery. HIgher values menas better health

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Eva Rasmussen Barr, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ACTUAL): January 14, 2021
• Study Completion (ACTUAL): January 14, 2022

Study Registration Dates

• First Submitted: December 31, 2019
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: physiotherapy; prehabilitation; spinal stenosis
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: SLS-683231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No