PRE Surgery reHABilitation for Spinal Stenosis

Low Back Pain Clinical Trial

— PreShab  

Official title:

PRE Surgery reHABilitation for Patients Suffering From Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330885
• Other study ID #: SLS-683231
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: January 14, 2022

Study information

• Verified date: March 2022
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Low Back Pain
• Physiotherapy
• Rehabilitation
• Spinal Stenosis

Intervention

Other:
• Supervised abdominal exercises and stationary biking
Explain pain to the patients in order to minimize fear of movement

Locations

Country	Name	City	State
Sweden	Ryggkirurgiskt Centrum	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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