Fusion or Not - a Study on Low Back Pain

NCT06709391 | Recruiting DMC

• 2 other identifiers: Protocol version 1.030
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 4

Brief Summary

Problems from the musculoskeletal system are one of the most common reasons for disability and sick leave. These problems include low back pain. Low back pain affects as many as 8 out of 10 individuals at some point in life. In most people it is quickly transient with little, or only short-term, impact on function and quality of life. In some individuals, the problems can become long-lasting and significantly impair the quality of life. When analgesic and physiotherapeutic treatment have been tried and the problems are still not manageable, and have lasted more than a year, surgical treatment consisting of fusion surgery of the painful part of the spine may come in question. In Sweden, approximately 600 fusion surgeries are performed annually for low back pain. There are a few randomized studies comparing fusion surgery for low back pain with non-surgical treatments, but these have showed different results. The effect of fusion surgery on low back pain is therefore uncertain. Surgical treatments brings with it a clear placebo effect. Other studies on pain in other parts of musculoskeletal system than the back has not been able to show that a surgical treatment is always better than placebo surgery. This has called into question the effect of surgery on many painful conditions of the musculoskeletal system. No placebo-controlled surgical studies have been done on fusion surgery for low back pain. A placebo surgical controlled study is the only way to ascertain whether fusion surgery is the right treatment for low back pain. In this study, 90 individuals will undergo surgical treatment for low back pain. After surgical exposure, the surgeon will be informed whether fusion surgery should be performed or not. Half of the patients will undergo a fusion procedure with implants and the other half will not undergo the fusion procedure and will not receive implants. Treatment randomization will be performed during surgery, and the individuals undergoing treatment and the staff taking care of the individual after surgery will be blinded for treatment allocation during 6 months. That means that the individuals participating in the study and the staff who meet the individuals after surgery won't know if the individual had fusion surgery or no fusion surgery until after the 6 month follow-up. The most important outcome of the study is the result of a questionnaire-based measure of back function answered by the participating individuals.

Conditions

Low Back Pain, Mechanical; Degenerative Disc Disease Lumbar

Keywords

Low back pain, degenerative disc disease, lumbar spine, surgery

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  The primary outcome variable is change in Oswestry Disability index (ODI) from baseline (preoperative) to the 6-month follow-up. ODI is a back specific index measuring disability due to back pain. It is the recommended instrument for studies concerning low back problems. An index from 0-100 is calculated. An ODI of 0-20 indicate minimal disability, 21-40; moderate disability, 41-60; severe disability, 61-80; severely crippled, 81-100; bed-bound.

  From baseline to the 6-month follow-up.

Secondary Outcomes (46)

• Numeric rating scale back pain

  From baseline to the 6-month follow-up.

• EQ-5D

  From baseline to the 6-month follow-up.

• General pain intensity

  From baseline to the 6-month follow-up.

• Oswestry Disability Index

  At the 3-month follow-up.

• Oswestry Disability Index

  At the 6-month follow-up.

Study Arms (2)

Fusion surgery

ACTIVE COMPARATOR

Fusion surgery with implants

Procedure: Fusion surgery

Non-fusion surgery

SHAM COMPARATOR

No fusion is performed. No implants are placed.

Procedure: Non-fusion surgery

Interventions

Fusion surgery PROCEDURE

After anaesthesia, the surgical area is identified through intraoperative fluoroscopy. After sterile draping, incision is made through skin and subcutaneous fat. Dissection is performed bilaterally down to the facet joints and transverse processes. Intraoperative fluoroscopy or computed tomography is performed to verify the surgical level. When the dissection is complete, randomization takes place. Randomization to fusion (active treatment): Pedicle screws are placed. Interbody cages may be used. Fluoroscopy or intraoperative computed tomography with or without intraoperative navigation is performed for correct implant positioning. Decortication is performed in the surgical area, and the cartilage in the facet joints is partially removed to allow fusion. Local bone graft is used and placed in the surgical area. Rods are placed in the screws and the fixation system is locked. Local anaesthesia is given in the surgical area. Fascia, subcutaneous tissue, and skin is sutured.

Fusion surgery

Non-fusion surgery PROCEDURE

After anaesthesia, the surgical area is identified through intraoperative fluoroscopy. After sterile draping, incision is made through skin and subcutaneous fat. Dissection is performed bilaterally down to the facet joints and transverse processes. Intraoperative fluoroscopy or computed tomography is performed to verify the surgical level. When the dissection is complete, randomization takes place. Randomization to non-fusion surgery (control): No implants are placed. No decortication is performed. The facet joints are left intact. Local anaesthesia is given in the surgical area. Fascia, subcutaneous tissue and skin is sutured.

Non-fusion surgery

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Axial, mechanical, stabbing pain localized to the lower lumbar spine, persisting for at least 12 months, in which non-surgical treatments have been unsuccessful
• A perceived improvement of back muscle strength after structured physical exercise, but severe, quality-of-life-reducing pain persists
• No symptoms or clinical signs of radiculopathy or neurogenic claudication (spinal stenosis)
• Numeric rating scale back pain of at least 5 (on a 0-10 (worst) scale)
• Oswestry Disability index of at least 35 (on a 0-100 (worst) scale)
• MRI-confirmed degenerative disc disease at L4/L5 and/or L5/S1.
• years of age
• American Society of Anesthesiologists (ASA) classification 1 or 2.
• No previous spine surgery, except for previous discectomy without fusion on the symptomatic level
• Written informed consent

You may not qualify if:

• Inability to give informed consent
• Unable to understand Swedish
• Unable to attend follow-up visits
• Severe osteoporosis making the patient unfit for surgery
• Severe cardiovascular, pulmonary or other chronic disease making the patient unfit for surgery
• Isthmic or degenerative spondylolisthesis, grade 2 or larger
• New or old fractures
• Spondylodiscitis
• Anchylosing spondylitis or other inflammatory process in the spine
• Active neoplasm
• Symptoms and clinical signs of nerve root compression or neurogenic claudication requiring decompressive surgery

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Karolinska Institutet: collaborator
• University of Oslo: collaborator
• Aleris Hospital: collaborator
• Ryggkirurgiskt centrum, Stockholm: collaborator

Study Sites (4)

Sahlgrenska university hospital

Gothenburg, Sweden

RECRUITING

Ryggkirurgiskt centrum

Stockholm, 11433, Sweden

RECRUITING

Uppsala University

Uppsala, 75185, Sweden

RECRUITING

Aleris Elisabetsjukhuset

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Gerdhem, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Christian Carrwik, MD, PhD

  Uppsala University Hospital

  STUDY DIRECTOR

• Karin Jensen, MD, MSc Psych

  Karolinska Institutet

  STUDY DIRECTOR

• Jens Ivar Brox, MD, PhD

  Oslo University

  STUDY DIRECTOR

• Catharina Parai, MD, PhD

  Sahlgrenska University Hospital

  STUDY DIRECTOR

• Martin Skeppholm, MD, PhD

  Ryggkirurgiskt centrum, Stockholm

  STUDY DIRECTOR

Central Study Contacts

Paul Gerdhem, MD, PhD

CONTACT

+46(0)186110000; paul.gerdhem@uu.se

Christian Carrwik, MD, PhD

CONTACT

+46(0)186110000; christian.carrwik@akademiska.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2037
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (4)