PRE Surgery reHABilitation for Spinal Stenosis

NCT04330885 | Completed

• 1 other identifier: SLS-683231
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Rehabilitation; Physiotherapy

Keywords

prehabilitation; spinal stenosis; physiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change of Fear of movement

  6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

• Change of Self efficacy: Self efficacy scale 0-64

  6 weeks pre-surgery, pre-surgery, 3 and 12 months after surgery

• Change of General Health higher value means better health

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

Other Outcomes (2)

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

  12 months after surgery

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

  6 weeks pre-surgery, pre -surgery, 3 and 12 months after surgery

Study Arms (2)

Prehab group

EXPERIMENTAL

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

Care as usual

NO INTERVENTION

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.

Interventions

Supervised abdominal exercises and stationary biking OTHER

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

Also known as: Explain pain

Prehab group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Ryggkirurgiskt Centrum

Stockholm, Sweden

Location

MeSH Terms

Conditions

Low Back Pain; Spinal Stenosis

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Eva Rasmussen Barr, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator does not take part in data collection. All data collected via web based surveys.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Model Details: 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

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: April 2, 2020
• Study Start: August 1, 2019
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2022
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)